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For Peer Review Only Exercise Therapy in the treatment of primary dysmenorrhea: a systematic review and meta-analysis Journal: Physical Therapy Manuscript ID PTJ-2018-0179.R2 Manuscript Category: Review (systematic, meta-analysis, scoping) Section: Women's Health Keywords: dysmenorrhea, Exercise Therapy, Physical Therapy Modalities, Women's Health, meta-analysis PTJ Manuscript in Review Physical Therapy
For Peer Review Only 1 EXERCISE THERAPY IN THE TREATMENT OF PRIMARY DYSMENORRHEA: A SYSTEMATIC REVIEW AND META-ANALYSIS Page 1 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 2 PRÉCIS Therapeutic exercise reduces pain intensity in patients with primary dysmenorrhea, as well as the duration of pain measured in hours. Page 2 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 3 ABSTRACT Objectives: to study the efficacy of physical exercise in pain intensity in primary dysmenorrhea, assess the effectiveness in the duration of pain and in the improvement of quality of life. Data Sources: the search was conducted between February 2017 and May 2017 in the databases WoS, PEDro, PubMed, Scopus, CINAHL, Dialnet and Google Scholar; using the terms dysmenorrhea, exercise therapy, exercise movement technique, exercise, physical therapy, physical therapy speciality, treatment, primary dysmenorrhea, prevention, etiology, epidemiology, pain. Methods of Study selection: We included RCTs, studies conducted on women aged 16- 25 years with primary dysmenorrhea, studies that included exercise as a type of therapy, studies that assess pain in intensity and duration and quality of life and studies published in English or Spanish. Studies that included women with irregular cycles, women diagnosed with a gynecological disease, operated on or serious diseases or who use intra-cavitary or oral contraceptives were excluded. We started with 455 studies, of which 16 were included in the systematic review and 11 in the three meta-analyses carried out. Tabulation, integration and results: Therapeutic exercise can be considered as a useful tool in the treatment of primary dysmenorrhea, in terms of reduction of pain intensity, with moderate evidence. Regarding the duration of pain and quality of life, the evidence is low and very low, respectively. Of the three meta-analyzes performed, the results are significantly (p <0.05) positive in favour of exercise in all three, that is, both in the decrease in intensity and in duration of pain. Page 3 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 4 Conclusion: Therapeutic exercise reduces pain intensity in patients with primary dysmenorrhea. Page 4 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 5 INTRODUCTION Dysmenorrhea, whose term is broken down from the Greek terms dys (difficult), mens (month) and rhoia (flow) whose literal meaning is a difficult menstrual flow.(1) It is defined as painful menstruation and was classified in 1992 by WHO within the International Statistical Classification of Diseases and Other Health Problems (ICD-10), in which it is classified as primary, secondary and non-specific.(2) Within this classification, we find that the most common is primary dysmenorrhea, which is defined as menstrual pain in the lower abdominal area before or during menstruation, without signs of pelvic pathology and between one or two years after menarche, or between 6 and 12 months later and can remain until 40 years of age, even continue during menopause.(3–5) We are facing a health problem that has a high impact on health, society, which implies a high economic cost and absenteeism from work.(4– 6) Its incidence is variable, since the majority of women do not demand health care, so the data vary according to the study. However, the WHO establishes its prevalence between 16.8-81.0%,(1) decreasing with age to age 25.(3,7) In addition, we found that this prevalence is associated more with a gynecological than chronological age.(8) Women with this health problem report as most common symptoms: pain in the lower abdomen, swollen abdomen, sadness, depression, irritability, mastalgia, low back pain, nausea, vomiting or diarrhea.(3,7,9) Pain suffered can be classified as moderate-severe pain, which has a negative effect on the quality of life, affecting 72.8% of women who suffer from it.(10) Although it is important to highlight the role of risk factors, both genetic(4) and personal,(9,11) recent research indicates that one of the main causes of dysmenorrhea Page 5 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 6 first is an excessive production of prostaglandins, which causes uterine contractions and ischemia, which leads to the onset of pain. However, there are other possible causes such as bleeding, production of lysosomes or progesterones, arachidonic acid, arginine vasopressin, proinflammatory cytokines, beta-growth factor or ovarian steroids, among others.(1,3,4,9) While other studies show changes in brain areas, whether in areas of glucose metabolism or changes in the distribution of brain gray matter in areas related to pain processing, as well as changes in the factor Val66Met that plays a role in the modulation of pain at the central level.(11,12) In relation to the approach of this health problem, although some drugs, such as nonsteroidal anti-inflammatory drugs or oral contraceptives, are shown to be an effective treatment for dysmenorrhea, therapeutic exercise is another therapeutic option to reduce the symptomatology of this health problem, with a low cost and absence of side effects. The application of physical exercise as a treatment of primary dysmenorrhea began to be postulated by Mosler, in 1914, he hypothesized that exercise decreased menstrual pain by pumping blood out of the uterus.(13,14) Later and more recent studies postulate that physical exercise reduces stress, pain and prostaglandin levels.(15–20) Therefore, the use of physical exercise as a therapy has not only been shown to improve the symptoms of pain and mental health, but also the quality of life. However some studies determine that its efficacy is not yet clear, because evidence of work focused on therapeutic exercise is found in limited randomized clinical trials,(21) while others defend its effectiveness when compared with some NSAIDs.(11) In the scientific literature, two previous systematic reviews (22,23) analyze the efficacy of therapeutic exercise in women with dysmenorrhoea, both focus on assessing the Page 6 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 7 intensity of pain and duration of the same, and cover a group of female population without limiting the sample´s age. Being conscious on the one hand, that a higher level of affectation and the presence of more symptomatology usually occurs between 16 and 25 years old, and on the other, that there are a large number of women with primary dysmenorrhoea who doubt whether to do physical exercise or not because of fear or ignorance if pain will increase, or simply by the presence of pain(24), which negatively affects their lives, the research objectives of this review are: to study the efficacy of physical exercise in the treatment of primary dysmenorrhea in pain intensity, to assess the efficacy of therapeutic exercise in the duration of pain and to evaluate the efficacy of therapeutic exercise in the improvement of the quality of life in women between 16 and 25 years old. METHODOLOGY In this study, we conducted a systematic review of randomized clinical trials following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyzes) standards. The bibliographic search took place from February 10, 2017 to May 31, 2018. The criteria that had to be met by the studies to be included were: randomized controlled clinical trials published until January 31, 2018, studies performed in women aged 16-25 years with primary dysmenorrhea, bearing in mind that this is the age range where patients have a higher frequency of symptoms,(25–28) studies that included exercise as a type of therapy in one of the intervention groups, studies in which pain and / or quality of life are assessed and studies published in English or Spanish. Studies that included women with abnormal menstrual cycles, studies that included women Page 7 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 8 diagnosed with gynecological diseases, operations or serious diseases, studies that included women using intracavitary or oral contraceptives, were excluded from the review. For the search of information, the selected databases were Web of Sciences, PubMed, Dialnet, CINAHL, PEDro and Scopus; applying the strategies and terms listed in table 1. To minimize publication bias, a search was performed on clinicaltrial.gov, a relevant database for grey literature. Table 1: Search strategies The variables of the results considered in our study are: pain as the main variable and quality of life as a secondary. The evaluation of the methodological quality of the studies was carried out by means of the PEDro scale. This review of the quality of the studies was carried out by two independent assessors, with a third one being consulted in situations of discrepancy. Included studies were rated according to scoring of 9–10, 6–8 and ≤5, and were interpreted as “excellent”, “good” and “fair” quality studies.(29) The quantitative synthesis of the results (meta-analysis) was carried out by another of the authors. Three different meta-analyzes were carried out, two referring to pain intensity (in the first, pain intensity after the intervention was taken as the outcome variable and in the second the difference in pain levels between baseline and post- Page 8 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 15 Duration of pain Unlike intensity, the duration of pain is not a variable that has been measured in all studies. In the 8 articles included in this review, in which this variable was measured, we observed that there was a significant decrease in five studies (26,27,32,33,36), of which three(27,32,36) reach 7 points on PEDro scale, that is, good quality, another(26) with 6 points (good quality) and finally one(33) with fair quality (4 points), while three(34,35,38) did not find significant improvements in exercise groups compared to control groups (one having(38) a fair quality according to PEDro scale, 5 points, and the other two(34,35) good, 7 points). It seems therefore that there is low evidence on the effectiveness of exercise in reducing pain duration. In the third meta-analysis carried out, statistically significant differences were also found between the groups (Mean Difference = -4.38 IC (95%): [-5.17; -3.60]), regarding pain duration. That is, in the experimental group the duration of menstrual pain was significantly less than in the control group (figure 5). Figure 5: Forest plot of the comparison in the two groups of the duration of pain. We again obtained that there was no publication bias as indicated by the Begg and Egger tests (p> 0.05). This is also seen in the funnel plot shown below (figure 4). The sensitivity analysis carried out indicates that no study substantially modifies the overall results when eliminating them. Figure 5 shows the meta-analysos on pain duration, finding that the studies with a greater impact of exercise on pain duration were those performed by Abbaspour et Page 15 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 16 al.(26) and Azima et al.(33). Abbaspour e al.(26), showed again the biggest mean difference between groups (4.64 hours) with a good methodological quality (PEDro = 6/10), followed by Azima et al.(33) (mean difference = 3.06 hours and good methodological quality PEDro = 7/10). Stretching and isometric exercises, applied for eight weeks, were the best treatments. Quality of life The quality of life, it is only present in four works. Three of them(31,39,41) did find that there is a significantly greater increase in quality of life in the groups of patients who do physical exercise, but only one(31) of them is of excellent quality (9 points in PEDro) and the other two(39,41) are of fair quality (3 and 5 points respectively), while the one performed by Chaudhuri et al.(28) obtained opposite results (with PEDro = 7/10). Therefore, there is very low evidence about the effectiveness of physical exercise when improving the quality of life of women with dysmenorrhea. The greater impact of the exercise on quality of life was performed by Arora et al.(39), that found significant differences in favor of aerobic exercise (applied during 12 weeks) in the eight domains of the SF-36 questionnaire. Yonglitthipagon et al.(31) found that there were significant improve in yoga (practiced for 12 weeks) group more than control group in 6 domains of SF-36 (functional capacity, vitality, mental health, social aspects, pain and general health. Finally, Sutar et al.(41) described that only the Physical Domain of Quality of life showed significant difference in favor of aerobic exercises group (applied during 12 weeks). Page 16 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 17 DISCUSION Following the systematic review and metaanalysis of the studies included in this review, the results suggest that therapeutic exercise for primary dysmenorrhoea in young women appears to be effective in relation to pain, with a moderate recommendation for intensity and low for duration. As for quality of life, the recommendation is very low but there were few studies that analyzed this result (Figure 6). Although these results show that there is improvement from a statistical analysis, it is necessary to carry these results from a clinical point of view. In this line, and in relation to pain intensity, studies focused on dysmenorrhoea in women with endometriosis point out that the MCID for VAS varies between-39mm(43) data that stray from those found in our review (-18,6 mm), and -10 mm found by Bourdel et al.(44), to which our results would fit the MCID. However, this comment should be treated cautiously because these studies do not focus on primary dysmenorrhoea but on endometriosis. As stated above, it is difficult to determine the clinical relevance of any of the variables in our study, neither intensity, nor duration of pain or quality of life, since the data found correspond to another health problem as in the case of pain intensity, or there is no data to support such relevance for pain duration or quality of life. Comparing our results with existing literature, and focusing on the variables intensity and duration of pain, another 3 systematic reviews were found prior to ours (Abaraougu et al.(22), Brown et al.(45) and Matthewman et al.(23)). In the case of Brown et al.(45), they analysed only one clinical trial, with a small sample and methodological deficiencies, limiting their results and showing the scarcity of evidence; as for the review of Abaraougu et al.(22), and Matthewman et al.(23) their findings are in line with ours, suggesting that therapeutic exercise can be beneficial and a therapeutic option for pain in the case of primary dysmenorrhoea. However, like us, they believe Page 17 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 18 that the quality of the studies is not sufficiently high to be able to affirm it in a forceful way. In relation to the quality of life variable was also raised in the review from Abaraougu but the data provided come from a single study and low methodological quality. In our case, the data provided comes from four randomized clinical trials, with methodological quality varying from low to high, which make use of valid and reliable tools for their measurement, and whose results suggest that physical exercise seems to have a positive effect on improving the quality of life in young women with primary dysmenorrhoea. It is necessary to emphasize in this revision, not only the inclusion of the quality of life as variable, secondary but not less important given the impact of this health problem and of the pain supposes for the population, but also by the population reason of study, since in this revision the sample is limited to women between 16 and 25 years, population that most often suffer this health problem and with greater severity. One of the relevant aspects to be highlighted in this review is the great heterogeneity in relation to the intervention applied in each one of the studies, heterogeneity in terms of: type of exercise, if it is combined or isolated, and dosage. This fact has not allowed to include an analysis in the quantitative review. However, physical exercise programs have been included in the qualitative synthesis for each variable of this review, and the following data have been extracted and summarized: the most effective exercise programs are stretching and isometrics exercises for 8 weeks in pain intensity and duration, yoga for 12 weeks in intensity pain and quality of life and also aerobic exercises for 12 weeks in quality of life. Page 18 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 19 CONCLUSION Therefore, we can conclude that therapeutic exercise during 8-12 weeks is a useful therapeutic option for young women with primary dysmenorrhoea, since it produces a decrease in pain intensity and to a lesser extent in duration, while for quality of life although it seems that therapeutic exercise produce an improvement, the evidence is still low. More studies of high quality methodological are necessary and that include the measurement of quality of life in these women, given the impact that this health problem implies for many of them. REFERENCES 1. Dorrego Leal MJ. Estudio epidemiológico de los factores de riesgo psicológicos y de comportamiento de la dismenorrea. Universidade de Santiago de Compostela. Facultade de Medicina e Odontoloxía. Facultade de Psicoloxía; 2015. 2. World Health Organization. International Classification of Diseases. 10th revision, 2nd ed. Geneva: Worl Health Organization; 2016. 3. Ortiz M. Primary dysmenorrhea among Mexican university students: prevalence, impact and treatment. Eur J Obstet Gynecol Reprod Biol. Ireland; 2010 Sep;152(1):73–7. 4. Habibi N, Huang MSL, Gan WY, Zulida R, Safavi SM. Prevalence of Primary Dysmenorrhea and Factors Associated with Its Intensity Among Undergraduate Page 19 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
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For Peer Review Only 23 intensity of primary dysmenorrhea based on McGill pain questionnaire among Shiraz University students. J Res Med Sci. India; 2016;21:104. 28. Chaudhuri A, Singh A, Dhaliwal L. A randomised controlled trial of exercise and hot water bottle in the management of dysmenorrhoea in school girls of Chandigarh, India. Indian J Physiol Pharmacol. India; 2013;57(2):114–22. 29. Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. England; 2018 Jan;8(1):506. 30. Ortiz MI, Cortes-Marquez SK, Romero-Quezada LC, Murguia-Canovas G, Jaramillo-Diaz AP. Effect of a physiotherapy program in women with primary dysmenorrhea. Eur J Obstet Gynecol Reprod Biol. Ireland; 2015 Nov;194:24–9. 31. Yonglitthipagon P, Muansiangsai S, Wongkhumngern W, Donpunha W, Chanavirut R, Siritaratiwat W, et al. Effect of yoga on the menstrual pain, physical fitness, and quality of life of young women with primary dysmenorrhea. J Bodyw Mov Ther. United States; 2017 Oct;21(4):840–6. 32. Azima S, Bakhshayesh HR, Kaviani M, Abbasnia K, Sayadi M. Comparison of the Effect of Massage Therapy and Isometric Exercises on Primary Dysmenorrhea: A Randomized Controlled Clinical Trial. J Pediatr Adolesc Gynecol. United States; 2015 Dec;28(6):486–91. 33. Azima S, Bakhshayesh H, Abbasnia K, Kaviani M, Sayadi M. Effect of Isometric Exercises on Primary dysmenorrhea: a randomized controlled clinical trial. Galen Med J. 2015;4(1):26–32. 34. Shirvani MA, Motahari-Tabari N, Alipour A. Use of ginger versus stretching Page 23 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 24 exercises for the treatment of primary dysmenorrhea: a randomized controlled trial. J Integr Med. Netherlands; 2017 Jul;15(4):295–301. 35. Motahari-Tabari N, Shirvani MA, Alipour A. Comparison of the Effect of Stretching Exercises and Mefenamic Acid on the Reduction of Pain and Menstruation Characteristics in Primary Dysmenorrhea: A Randomized Clinical Trial. Oman Med J. Oman; 2017 Jan;32(1):47–53. 36. Rakhshaee Z. Effect of three yoga poses (cobra, cat and fish poses) in women with primary dysmenorrhea: a randomized clinical trial. J Pediatr Adolesc Gynecol. United States; 2011 Aug;24(4):192–6. 37. Shah S, Verma N, Begani P, Nagar H, Mujawar N. Effect of Exercises on Primary Dysmenorrhoea in Young Females shah. Int J Physiother Res. 2016;4(5):1658–62. 38. Yang N-Y, Kim S-D. Effects of a Yoga Program on Menstrual Cramps and Menstrual Distress in Undergraduate Students with Primary Dysmenorrhea: A Single-Blind, Randomized Controlled Trial. J Altern Complement Med. United States; 2016 Sep;22(9):732–8. 39. Arora A, Yardi S, Gopal S. Effect of 12-Weeks of Aerobic Exercise on Primary Dysmennorrhea. Indian J Physiother Occup Ther. 2014;8(3):130–5. 40. Patel N, Tanna T, Bhatt S. Effect of Active Stretching Exercises on Primary Dysmenorrhea in College Going Female Students. Indian J Physiother Occup Ther. 2015;9(3):72–6. 41. Sutar A, Paldhikar S, Shikalgar N, Ghodey S. Effect of aerobic exercises on primary dysmenorrhoea in college students. IOSR J Nurs Heal Sci. Page 24 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 31 Mean age: 20.8±1.8 Azima S et al (2015)(33) Iran N= 68 (34 isometric exercise – 34 control) Mean age: 20.73 ± 1.08 control, 21.08 ± 1.21 experimental BMI: 21.18 ± 2.56 control, 21.19 ± 2.41 experimental Menarche age: 13.32 ± 1.90 control, 13.29 ± 1.40 experimental Menstruation interval: 25.82 ± 3.45 days control, 25.55 ± 4.26 days experimental Duration bleeding: 4.76 ± 1.15 days control, 4.52 ± 1.10 days experimental Menstrual cycle duration: 6.76 ± 0.88 days control, 6.85 ± 1.04 days experimental Yang NY et al (2016)(38) South Korea N= 40 (20 yoga – 20 control) Age: 20 years (16.7% experimental), 21 years old (77.8% experimental, 83.3% control), 22 years old (5.6% experimental, 11.1% control), 23 years old (5.6% control) Cycle regularity: 47.2% regular, 52.8% irregular Start pain: menarche (22.2% experimental - control), 1st year (16.7% experimental - control), 1-2 year (44.4% experimental, 50.0% control), others (16.7% experimental, 11.1% control) Days spasms: before the period (5.6% experimental, 11.1% control), during the period (44.4% experimental, 55.6% control), 2nd day (50.0% experimental, 33.3% control) Menarche age: 13.28 ± 1.32 control, 14.11 ± 1.57 experimental Menstrual cycle: 32.61 ± 10.57 days control, 29.78 ± 4.04 days experimental Duration period: 5.89 ± 1.13 days control, 5.83 ± 2.77 days experimental BMI: 20.44 ± 1.66 control, 20.86 ± 1.41 experimental Azima S et al (2015)(32) Iran N= 102 (34 isometric exercise – 34 massage – 34 control) Nulliparous Average age: 21.08 ± 1.21 years control, 20.73 ± 1.08 years exercise, 21.14 ± 0.95 massage Menarche: 13.29 ± 1.40 years control, 13.32 ± 1.09 years exercise, 12.85 ± 1.41 years massage Cycle interval: 25.55 ± 4.26 days control, 25.82 ± 3.45 days exercise, 25.5 ± 3.5 days massage Duration bleeding: 4.52 ± 1.10 days control, 4.76 ± 1.15 days exercise, 4.64 ± 1.32 days massage Menstrual cycle: 6.85 ± 1.04 days control, 6.76 ± 0.88 days experimental, 6.61 ± 1.20 days massage Arora A et al (2014)(39) India N= 60 (30 aerobic exercise – 30 control) Mean age: 20.4±1.54 experimental, 20.73±1.5 control Patel NS et al (2015)(40) India N= 120 (60 aerobic exercise – 60 control) Average age: 21.35 years experimental, 21.28 years old control Height: 159.5cm experimental, 158.3cm control Weight: 49.88Kg experimental, 47.88Kg control Sutar A et al (2016)(41) India N=100 (50 aerobic dance – 50 control) Yonglitthipagon P et al (2017)(31) Thailand N= 34 (17 yoga – 17 control) Age: 19.71 ± 1.36 yoga, 20.06 ± 1.03 control Menarche: 12.29 ± 1.05 yoga, 12.12 ± 1.27 control Page 31 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 32 Height: 159.68 ± 5.10 yoga, 158.41 ± 6.00 control Weight: 55.41 ± 8.52 yoga, 54.15 ± 11.62 control BMI: 21.72 ± yoga, 21.53 ± 4.25 control Shirvani MA et al (2017)(34) Iran N= 122 (61 stretching exercises – 61 control) Age: 21.60 ± 2.14 ginger, 21.32 ± 1.96 exercise BMI: 21.65 ± 3.08 ginger, 22.56 ± 3.56 exercise Motahari-Tabari N et al (2017)(35) Iran N= 122 (61 stretching exercise – 61 mefenamic acid group) Age: 21.6 ± 2.0 MA, 21.3 ± 2.0 years BMI: 21.8 ± 2.9 MA, 22.6 ± 3.6 years Abbaspour Z et al (2006)(26) Iran N= 142 (97 aerobic exercise - 45 control) Age: 15-18 years Chaudhuri A et al (2013)(28) India N= 128 (53 girls in school 1 and 75 girls in school 2) (53 experimental group; 75 control) Prevalence of dysmenorrhea: 57.61% school 1; 62.77% school 2 Median age: 14.0 school 1; 14.0 school 2 Absent from school: 22 school 1; 11 school 2 Bed rest: 23 school 1; 59 school 2 Visited doctor: 5 school 1; 6 school 2 Nag U et al (2013)(42) India N= 113 (60 yoga - 53 control) Age: 18-23 years Behbahani BM et al (2016)(27) Iran N= 120 (40 acupressure – 40 isometric exercise – 40 control) Mean age: 20.02±1.44 acupressure group, 20.12±1.50 training group, 20.37±1.54 control group Mean age time of beginning of pain after menarche: 1.80±0.82 acupressure group, 1.90±0.77 training group, 1.87±0.79 control group Rakhashaee (2011)(36) Iran N= 92 students (50 yoga - 42 control) Age: 18-20 years old Mean age: 20.86 yoga group, 20.45 control group Menarche age: 13.2 yoga group, 13.4 control group Dysmenorrhea age: 15.5 yoga group, 15.7 control group Page 32 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 33 TABLE 3: METHODOLOGICAL QUALITY OF THE STUDIES AND RESULTS OBTAINED ON PAIN INTENSITY, PAIN DURATION AND QUALITY OF LIFE. AUTHOR PEDro scale Mejora intensidad dolor Mejora duración dolor Mejora calidad de vida Ortiz MI et al(30) 9/10 X - - Shah S et al(37) 5/10 X - - Azima S et al(33) 7/10 X X - Yang NY et al(38) 5/10 X O - Azima S et al(32) 7/10 X X - Arora A et al(39) 5/10 X - X Patel NS et al(40) 4/10 X - - Sutar A et al(41) 3/10 X - X Yonglitthipagon P et al(31) 9/10 X - X Shirvani MA et al(34) 7/10 X O - Motahari-Tabari N et al(35) 7/10 O O - Abbaspour Z et al(26) 6/10 X X - Chaudhuri A et al(28) 7/10 O - O Nag U et al(42) 5/10 X - - Behbahani BM et al(27) 7/10 X X - Rakhshaee Z et al(36) 7/10 X X - X: significant differences in favor of “therapeutical exercise”. O: no significant differences in favor of “therapeutical exercise”. -: no data were collected. TABLE 4. INTERVENTIONS, OUTCOMES AND RESULTS. AUTHOR Intervention Evaluation PAIN INTENSITY PAIN DURATION QoL Ortiz MI (2015)(30) Experimental group: training program, 50 min/3 times a week. Physiotherapy program. Five phases: 5-10 repetitions. 1st Phase: general stretches, 10 minutes. 2nd Phase: specific stretches, 10 minutes. Stretches of the connective tissue around the pelvis, hip flexors and inner thigh muscles. 3 types of specific stretches. 3rd Phase: trot, 10 minutes. At an intensity of between 60-70% of the máximum cardiac rate. 4th Phase: Kegel exercises, 10 minutes. Involving contraction of the perineal musculature, 5 exercises proposed. 5th Phase: relaxation exercises, 10 minutes. Supine with Deep breathing through the nose and expulsión through the mouth. Control group: wait in the yard; standing, walking or talking. They do not perform stretching, Kegel exercises, yoga or relaxation Tool: VAS demographic questionnaire. Variables measured at the end of each period. During 3 periods. Significant differences in the second cycle and third cycle (p<0.05) in favor of the exercise group. Control group: VAS-baseline = 62.9 ± 1.5 Experimental group: VAS-baseline = 64.9 ± 1.3 Post-interventions means and standard deviations not provided. - - Page 33 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 34 exercises. Shah S (2016)(37) Between December 2014 to April 2015. Group A (experimental): 6 activities: abdominal, pelvic and inguina stretches. For 8 weeks: 4 days a week. No stretches during cycles. Group B (control): waiting period for 8 weeks. Questionnaire for menstruation and dysmenorrhea characteristics. Tool: VAS and Verbal Multidimensional Scoring System (VMSS) Control group: Pretest: 6.5±0.76 Postest: 6.4±0.75 Experimental group: Pretest: 6.3±1.22 Postest: 4.6±0.99 W group A: 171 W group B: 9 Pre-post (intragroup) comparison: Control group: p = 0.53 Experimental group: p = 0.0002 Comparison of difference in VAS between Groups: p < 0.0001 - - Azima S (2015)(33) Between November 2012 to May 2013. Experimental group: Perform isometrics on the 3rd day of menstration. 5 days a week, 2 sessions a day. 10 repetitions per session for 8 weeks. . ◦ 7 positions modified and confirmed by a specialized rehabilitator. ◦Isometric protocol. Control group: non-intervention. 1st month non-intervention: measurement of intensity, pain duration and anxiety in both. 2nd month: questionnaire in control and intervention program. Tools: VAS, pain hours, Spilerger quiestionnaire. (Anxiety level) Measurements at the end of the 1st, 2nd and 3rd cycle in both groups. Control group: 1st month: 6.61±2.04 2nd month: 6.941±1.94 3rd month: 6.67±1.96 Exercise group: 1st month: 6.58±1.67 2nd month: 4.64±2.60 3rd month: 4.17±2.12 Intragroup comparison: Control: p = 0.598 Exercise p < 0.001 Between groups comparison 1st month: p = 0.948 2nd month p <0.001 3rd month p <0.001 Control group: 1st month: 7.91±5.24 2nd month: 7.67±5.49 3rd month: 8.35±6.03 Exercise group: 1st month: 10.70±7.63 2nd month: 9.63±7.17 3rd month: 5.29±4.77 Intragroup comparison: Control: p = 0.562 Exercise p < 0.001 Between groups comparison 1st month: p = 0.083 2nd month: p = 0.793 3rd month: p = 0.024 - Yang NY (2016)(38) Diagnosis by a specialist. Two groups: experimental and control. Experimental: 12 week yoga program. Program guided by a certified yoga specialist: ◦ 10 cycles of surya namaskara for 15 min. ◦ 5 min shavasana of relaxation. ◦ 5 cycles: cat, cobra and fish, 10 min. ◦ 30 min yoga nidra. ◦ Do not perform other yoga activities. ◦ Avoid contact with the control group. Control group: did not participate in the program. Before the program: menstrual and demographic information, VAS, pain duration, Short Form Menstrual Distress Questionnaire (SF-MDQ). After the program: VAS, pain duration, SF-MDQ. Control group: Pre-test: 7.00±0.77 Week 12: 6.89±0.83 Exercise group: Pre-test: 7.33±0.69 Week 12: 5.49±0.73 Intragroup comparison: Control: p > 0.05 Exercise: p < 0.0001 Between groups comparison Pre-test: p = 0.053 Week 12: p = 0.001 Control group: Pre-test: 1.94±0.64 Week 12: 1.83±0.62 Exercise group: Pre-test: 1.89±0.58 Week 12: 1.67±0.69 Intragroup comparison: Control: p > 0.05 Exercise p < 0.05 Between groups comparison Pre-test: p = 0.002 Week 12: p = 0.449 - Azima S (2015)(32) Massage group: skin sensitivity test. ◦Supine. ◦ Upper pubic symphysis and navel (15 min each). ◦ Pain duration and intensity measured after massage ◦ Anxiety levels, 24 hours after the second massage. Questionnaire for anxiety levels. Measurements before the intervention. Pain intensity and duration was measured in the 3 intervention groups in 3 consecutive menstrual Control group: 1st month (before the intervention): 6.61±2.04 2nd month: 6.94±1.94 3rd month:: 6.67±1.96 Massage group: 1st month (before the Control group: 1st month (before the intervention): 7.91±5.24 2nd month: 7.67±5.49 3rd month:: 8.35±6.03 Massage group: 1st month (before the - Page 34 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 35 Exercise group: isometrics 3rd day of the cycle. ◦ 5 days/week, 2 sessions/day. ◦ 10 repetitions, 8 weeks. ◦ Pain intensity and duration in 3 consecutive cycles. ◦ Anxiety levels in 4th and 8th week after exercise. Control group: non-intervention. ◦ Intensity, duration and anxiety levels at the end of the 4th and 8th week after the cycle cycles. intervention): 7.05±1.85 2nd month: 4.26±2.59 3rd month:: 3.44±1.86 Exercise group: 1st month (before the intervention): 6.58±1.67 2nd month: 4.64±2.60 3rd month:: 4.17±2.02 Intragroup comparison: Control: p = 0.598 Massage: p < 0.001 Exercise: p < 0.001 Between groups comparison: 1st month: p = 0.509 2nd month p <0.001 3rd month p <0.001 intervention): 9±6.57 2nd month: 5.97±4.96 3rd month:: 4.73±3.58 Exercise group: 1st month (before the intervention): 10.7±7.63 2nd month: 9.63±7.17 3rd month:: 5.29±4.77 Intragroup comparison: Control: p = 0.562 Massage: p < 0.001 Exercise: p < 0.001 Between groups comparison 1st month: p = 0.214 2nd month p = 0.590 3rd month p = 0.006 Arora A (2014)(39) Experimental group: aerobic exercise program for 3 months. ◦ 10 min warm up. ◦ 30 min aerobic phase (74-84% FCM). ◦ 10 min cooling off. ◦3-5 times/week. 12 weeks of intervention Control group: without intervention. Questionnaire: medical, sociodemographic, ability and state of dysmenorrhoea characteristics, EVA, non-use of compresses during the maximum bleeding day, MDS and quality of life through the SF-36 questionnaire. Administration of the dysmenorrhea questionnaire before the intervention and after this collection of results. Control group: Pretest: 8.20+0.71 Difference Between Pre & Post: -0.13±0.93 Experimental group: Pretest: 7.93+0.86 Difference Between Pre & Post: 2.60±1.5 Between groups comparison: Pretest: p = 0.163 Difference Between Pre & Post: p <0.0001 - Control group: Difference Between Pre-Post: 2.99+4.88 Experimental group: Difference Between Pre-Post:14.36+11.3 Patel NS (2015)(40) Experimental group: Stretches for 8 weeks. ◦ 6 types of stretching. ◦ 3 days/week, twice/day, 8 weeks. ◦ Do not perform stretches during the period. Control group: do not perform any type of exercise. Measurements before the beginning of the program, after 4 weeks and after 8 weeks. Tools: VAS, Moos' Menstrual Distress Questionnaire (menstrual symptoms) Control group: Pretest: 7.417±1.418 8 week: 7.2±1.436 Experimental group: Pretest: 7.133±1.467 8 week: 3.017±0.9654 Between groups comparison: Pretest: p = 0.0367 8 week: p<0.0001 - - Sutar A (2016)(41) 8 weeks aerobic exercise: 3 days/week, 45 minutes/day. 3 cycles. ◦ 10 min heating. ◦ 25 min, 70-80% Borg scale aerobic exercise. Dance. ◦ 10 min cooling Control group: observation without exercises or lifestyle modification. Evaluation questionnaire, VAS, MSS (degree of dysmenorrhea), SF-36 (quality of life) Pain measurement at the onset and the three consecutive cycles. ◦ 24-36 hours menstruation start. ◦ Pre-intervention (4th week) and postintervention (8th week). P<0.05 in favor of the exercise group. Pre and Postinterventions means and standard deviations not provided. - When the eight domains of the SF-36 were compared between the first and third visits, all domains showed highly significant improvement within the group (pre and post intervention). The Physical Domain of Quality of life showed significant difference in the exercise group. Pre and Postinterventions means and standard deviations not Page 35 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 36 provided. Yonglitthipagon P (2017)(31) 12 weeks, February 2015—January 2016 Yoga group: 30 min before breakfast/dinner or 2 h after (shavasana, surya namaskar, supta vajrasana, janu sirsasana, pashimottanasana). Yoga teacher and home. Control group: nothing. 10 minutes telephone follow-ups to control Tools: VAS, SF-36 Measurement: On starting and at 12 weeks. Adjusted Means of Variable Measures after 12-week Experimental Setup Control: 4.17 Yoga: 2.30 Between groups comparison p=0.02 - Adjusted Means of Variable Measures after 12-week Experimental Setup SF-36 Functional capacity Control: 79.19 Yoga: 88.16 p=0.049 Physical limitation Control: 88.15 Yoga: 95.67 p=0.241 Emotional limitation Control: 82.35 Yoga: 88.24 p= 0.527 Vitality Control: 53.02 Yoga: 69.04 p<0.0001 Mental health Control: 59.45 Yoga: 73.73 p<0.0001 Social aspects Control: 69.17 Yoga: 83.78 p<0.0001 Pain Control: 69.13 Yoga: 82.79 p=0.008 General health Control: 53.14 Yoga: 71.27 p<0.0001 Motahari-Tabari N (2017)(35) Five months in 2014. Experimental group: 1. 5 min warm-up standing 2. 10 min six belly and pelvic stretching exercises 15 minutes, 3 times/week, 2 menstrual cycles (8 weeks). Not during menstruation. Two trained instructors taught exercise. Mefenamic acid (MA) group: 250mg capsules every 8 h from the onset of menstruation until pain relief, 2 cycles. VAS for pain intensity at the end of the first and second menstrual cycles. Control group (MA): At baseline: 55.0±20.4 1st cycle: 39.0±17.8 2nd cycle: 33.8±17.7 Experimental group: At baseline: 60.3±14.5 1st cycle: 45.4±19.2 2nd cycle: 31.6±16.03 Between groups comparison: At baseline: p=0.104 1st cycle: p=0.058 2nd cycle: p=0.477 Control group (MA): At baseline: 1.7±0.9 1st cycle: 1.4±0.6 2nd cycle: 1.6±0.7 Experimental group: At baseline: 1.8±0.7 1st cycle: 1.6±0.8 2nd cycle: 1.5±0.7 Between groups comparison: At baseline: p=0.444 1st cycle: p=0.131 2nd cycle: p=0.378 - Chaudhuri A (2013)(28) April 2010 — September 2010 Intervention group: physical education teacher and doctor. Practised except on the days of menstruation, two sessions/day, 10-15 minutes. 1. Lie face up with legs and knees semiflexed, abdominal breathing. 10 times. 2. Lie on back, bring knees to touch chin, straighten back the legs. 10 times. 3. Stand straight while holding the back of a chair, stand on toes for 10 seconds (heels raised), normal positions. 20 times. 4. Stand straight while holding the back of a MDQ for severity of dysmenorrhea and impact on life (18 questions). VAS for intensity of pain (0-10). Post intervention assessment: 1st, 2nd and 3rd months after beginning interventions. Control group: Baseline: 5.16 (CI: 4.8- 5.51) 1st month: 3.55 (CI: 3.14-3.95) 2nd month: 2.70 (CI: 2.34-3.05) 3rd month: 2.06 (CI: 1.74-2.37) Experimental group: Baseline: 5.75 (CI: 5.13- - Control group: Baseline: 14.92 (CI: 12.36-17.48) 1st month: 11.45 (CI: 9.26-13.63) 2nd month: 9.91 (CI: 7.22-12.59) 3rd month: 8.16 (CI: 5.40-10.91) Experimental group: Baseline: 14.53 (CI: Page 36 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 37 chair, do 5 deep knee bends, 15 seconds. 5. Stand with both knees semi-flexed and feet together. Hold a roll in the back of both knees, 1 minute. Once a week visits to repeat demonstrations. Initial training for 40-45 minutes, subsequent of 15-20 minutes. Control Group: Hot Water Bottle (HWB). Bottles wrapped in towels, applied over the lower abdomen, 15-20 minutes. Control by phone calls mothers. 6.36) 1st month: 4.36 (CI: 3.79-4.93) 2nd month: 3.46 (CI: 2.86-4.06) 3rd month: 2.96 (CI: 2.36-3.56) Intragroup comparison: Control: Baseline-1st month: p<0.001 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 Exercise: p < 0.001 Baseline-1st month: p<0.001 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 Between groups comparison: Baseline: p = 0.086 1st month: p = 0.022 2nd month: : p = 0.028 3rd month: : p = 0.007 11.39-17.66) 1st month: 14.11 (CI: 10.42-17.79) 2nd month: 9.02 (CI: 6.60-11.43) 3rd month: 7.85(5.34- 10.53) Intragroup comparison: Control: Baseline-1st month: p<0.001 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 Exercise: p < 0.001 Baseline-1st month: p=0.669 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 Between groups comparison: Baseline: p = 0.849 1st month: p = 0.203 2nd month: : p = 0.645 3rd month: : p = 0.878 Shirvani MA (2017)(34) January — May 2014. Experimental group: two trained instructors, practices with students: 1. 5 min of warm-up in standing position 2. 6 stretching exercises for the abdomen and pelvis for 10 minutes 15 min, 3 times/week, two consecutive menstrual cycles (8 weeks), not during menstruation. Control weekly. Ginger group (Control group): 250mg ginger capsules, at the onset of menstruation and every 6h until pain relief for 2 cycles. VAS to pain intensity. Other characteristics: pain duration, length of menstruation, menstrual cycle, change in bleeding) Record: at the end of the first and the second menstruation cycles. Control group: Baseline: 58.01±15.15 1st month: 43.49±19.99 2nd month: 38.19±20.47 Experimental group: Baseline: 60.26±14.45 1st month: 45.42±19.21 2nd month: 31.57±16.03 Intragroup comparison: Control group Baseline-1st and 2nd month: p < 0.0001 Experimental group Baseline-1st and 2nd month: p < 0.0001 Between groups comparison: Changes between baseline and 1st month p = 0.95 Changes between baseline and 1st month p = 0.02 Control group: Baseline: 1.62±0.85 1st month: 1.60±0.80 2nd month: 1.49±0.78 Experimental group: Baseline: 1.78±0.70 1st month: 1.59±0.78 2nd month: 1.50±0.72 Intragroup comparison Control group Baseline-1st and 2nd month: p = 0.69 Experimental group Baseline-1st and 2nd month: p = 0.02 Between groups comparison: Changes between baseline and 1st month p = 0.12 Changes between baseline and 1st month p = 0.16 - Nag U (2013)(42) From July to October 2010. 18-23 years. Yoga intervention: 24 yoga poses (navasana, matsyasana, dhanurasana, vajrasana, paschimotasana, ustrasana, ardhamatstyendrasana, salabhasana, bhujangasana sarvangasana, uttanapadasana, padmasana, and surya namaskara). Control group: nothing NRS (0-10) for pain intensity and PSS for stress (both). Both groups evaluated after three months. Control Group (53 subjects): Baseline: 2 mild pain, 44 reported mild to moderate pain, 9 severe pain. After 3 months: no change was observed in 52 subjects. Experimental group (60 subjects): Baseline: 2 mild pain, 47 moderate pain, 11 severe - - Page 37 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 38 pain. After 3 months: 53 subjects (88%) complete pain relief and 7 subjects mild pain. Intragroup comparison p<0.0001 Between groups comparison after 3 months: p<0.0001 (NRS) Rakhshaee Z (2011)(36) Yoga group (experimental): cobra, cat and fish poses, 14 days of menstrual cycle and on 20 min session in a day, morning before breakfast/lunch/dinner (3 hour after ordinary meal, 2 hour after light meal). Booklet with explanations Control group: nothing VAS for pain intensity. Evaluated for 3 menstrual cycles: first cycle no method, the second and third cycles with treatment. Control group complete questionnaire during menstruation. Control group: Pretest: 2.35±0.48 1st month: 2.45±0.67 2nd month: 2.38±0.66 Experimental group: Pretest: 2.54±0.50 1st month: 1.50±0.78 2nd month: 1.26±0.82 Intragroup comparison: Control group Baseline-1st and 2nd month: p = 0.448 Experimental group Baseline-1st and 2nd month: p < 0.0001 Between groups comparison: Baseline: p = 0.81 1st month: p < 0.001 2nd month: p < 0.001 Control group: Pretest: 40.57±17.4 1st month: 40±19.7 2nd month: 40.2±19.2 Experimental group: Pretest: 37.49±22.4 1st month: 32.1±21.8 2nd month: 33±69.4 Intragroup comparison: Control group Baseline-1st and 2nd month: p = 0.448 Experimental group Baseline-1st and 2nd month: p < 0.0001 Between groups comparison: Baseline: p = 0.471 1st month: p = 0.087 2nd month: p < 0.001 - Behbahani BM (2016)(27) Acupressure group: abdominal meridian using the thumb for 20 min (15s pressure, 15s rest) 1st and 2nd days of menstruation for 2 cycles. Pain intensity: 1/2h, 1h and 2h after application. Self-care behaviours: teaching theoretical (reading, discussion, experience sharing) four sessions (60-90min, once a week). Anatomy and physiology, nutrition during menstrual cycle. Second part: practical training, isometric exercises (by master of physical education) during menstrual cycle. 8 weeks, first 4 weeks – the researcher. Second 4 weeks – images of playing sports. Control: phone calls. Control group: ibuprofen 400mg, 3 times/day/3 cycles. Short Form McGill Pain Questionnaire: 15 sensory ítems (11 questions) and emotional (4 questions). Measurements before and after treatment. Acupressure group: Before intervention: 20.25±6.93 After intervention: 14.40±6.87 Intragroup comparison: p<0.001 Education group: Before intervention: 16.90±7.43 After intervention: 10.65±5.71 Intragroup comparison: p<0.001 Control group: Before intervention: 31.77±6.36 After intervention: 19±5.41 Intragroup comparison: p<0.001 Difference in severity of pain between measures: Education: 6.25±4.34 Control: 8.25±4.64 Acupressure: 2.70±3.45 Between groups comparison p<0.001 - - Abbaspour Z (2006)(26) Two cycles: before and after intervention Exercise group (experimental): Lie face up with legs and knees bent, perform abdominal breathing about 10 times Stand holding back of chair; lift one heel off the floor, then the other, repeat 20 times Stand holding back of chair then do 5 deep knee bends Tools: VAS, pain duration in hours Two observation cycles with measurement. Program in the 3rd and 4th cycles with Control group: Mean cycle 1-2 control: 8.84±0.893 Cycle 3 control: 9± 1.02 Cycle 4 control: 9±1.02 Experimental group: Mean cycle1-2: Control group: Mean cycle 1-2 control: 6.60±1.44 Cycle 3 control: 6.82± 2.60 Cycle 4 control: 6.87±2.56 - Page 38 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 39 While lying on back lift and bring knees to touch chin, 10 timesthey should do these physical activities twice a day for 20 min and stop them in menstruation Control group: observation measurement at the end. 8.59±1.21 Cycle 3 exp: 4.63±2.22 Cycle 4 exp: 2.84±2.18 Intragroup comparison: Control: p>0.05 Experimental: p<0.01 Between groups comparison: Mean cycle 1-2: p>0.05 Cycle 3: p<0.01 Cycle 4: p<0.01 Experimental group: Mean cycle1-2: 7.15±1.41 Cycle 3 exp: 4.32±2.52 Cycle 4 exp: 2.23±1.93 Intragroup comparison: Control: p>0.05 Experimental: p<0.01 Between groups comparison: Mean cycle 1-2: p>0.05 Cycle 3: p<0.01 Cycle 4: p<0.01 Page 39 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 1" " FIGURE LEGENDS Figure 1: Flow chart Figure 2: Forest plot of the comparison of the difference between groups in VAS postintervention. Figure 3: Forest plot for the comparison between the control groups and the intervention of the difference in pain measured with the VAS scale between pre- and postintervention. Figure 4. Funnel plots. From left to right: 1) funnel plot of the comparison between groups of pain intensity, measured with the EVA scale, in the post-test, 2) funnel plot of the comparison between groups of the difference in pain intensity, measured with the EVA scale, between pre-test and the post-test; 3) Funnel plot of comparison between groups of menstrual pain duration in the post-test. Figure 5: Forest plot of the comparison in the two groups of the duration of pain. Figure 6. GRADE evidence profile. Page 40 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 3" " Menarche age: 13.28 ± 1.32 control, 14.11 ± 1.57 experimental Menstrual cycle: 32.61 ± 10.57 days control, 29.78 ± 4.04 days experimental Duration period: 5.89 ± 1.13 days control, 5.83 ± 2.77 days experimental BMI: 20.44 ± 1.66 control, 20.86 ± 1.41 experimental Azima S et al (2015)(32) Iran N= 102 (34 isometric exercise – 34 massage – 34 control) Nulliparous Average age: 21.08 ± 1.21 years control, 20.73 ± 1.08 years exercise, 21.14 ± 0.95 massage Menarche: 13.29 ± 1.40 years control, 13.32 ± 1.09 years exercise, 12.85 ± 1.41 years massage Cycle interval: 25.55 ± 4.26 days control, 25.82 ± 3.45 days exercise, 25.5 ± 3.5 days massage Duration bleeding: 4.52 ± 1.10 days control, 4.76 ± 1.15 days exercise, 4.64 ± 1.32 days massage Menstrual cycle: 6.85 ± 1.04 days control, 6.76 ± 0.88 days experimental, 6.61 ± 1.20 days massage Arora A et al (2014)(39) India N= 60 (30 aerobic exercise – 30 control) Mean age: 20.4±1.54 experimental, 20.73±1.5 control Patel NS et al (2015)(40) India N= 120 (60 aerobic exercise – 60 control) Average age: 21.35 years experimental, 21.28 years old control Height: 159.5cm experimental, 158.3cm control Weight: 49.88Kg experimental, 47.88Kg control Sutar A et al (2016)(41) India N=100 (50 aerobic dance – 50 control) Yonglitthipagon P et al (2017)(31) Thailand Page 47 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 4" " N= 34 (17 yoga – 17 control) Age: 19.71 ± 1.36 yoga, 20.06 ± 1.03 control Menarche: 12.29 ± 1.05 yoga, 12.12 ± 1.27 control Height: 159.68 ± 5.10 yoga, 158.41 ± 6.00 control Weight: 55.41 ± 8.52 yoga, 54.15 ± 11.62 control BMI: 21.72 ± yoga, 21.53 ± 4.25 control Shirvani MA et al (2017)(34) Iran N= 122 (61 stretching exercises – 61 control) Age: 21.60 ± 2.14 ginger, 21.32 ± 1.96 exercise BMI: 21.65 ± 3.08 ginger, 22.56 ± 3.56 exercise Motahari-Tabari N et al (2017)(35) Iran N= 122 (61 stretching exercise – 61 mefenamic acid group) Age: 21.6 ± 2.0 MA, 21.3 ± 2.0 years BMI: 21.8 ± 2.9 MA, 22.6 ± 3.6 years Abbaspour Z et al (2006)(26) Iran N= 142 (97 aerobic exercise - 45 control) Age: 15-18 years Chaudhuri A et al (2013)(28) India N= 128 (53 girls in school 1 and 75 girls in school 2) (53 experimental group; 75 control) Prevalence of dysmenorrhea: 57.61% school 1; 62.77% school 2 Median age: 14.0 school 1; 14.0 school 2 Absent from school: 22 school 1; 11 school 2 Bed rest: 23 school 1; 59 school 2 Visited doctor: 5 school 1; 6 school 2 Nag U et al (2013)(42) India N= 113 (60 yoga - 53 control) Page 48 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 5" " Age: 18-23 years Behbahani BM et al (2016)(27) Iran N= 120 (40 acupressure – 40 isometric exercise – 40 control) Mean age: 20.02±1.44 acupressure group, 20.12±1.50 training group, 20.37±1.54 control group Mean age time of beginning of pain after menarche: 1.80±0.82 acupressure group, 1.90±0.77 training group, 1.87±0.79 control group Rakhashaee (2011)(36) Iran N= 92 students (50 yoga - 42 control) Age: 18-20 years old Mean age: 20.86 yoga group, 20.45 control group Menarche age: 13.2 yoga group, 13.4 control group Dysmenorrhea age: 15.5 yoga group, 15.7 control group TABLE 3: METHODOLOGICAL QUALITY OF THE STUDIES AND RESULTS OBTAINED ON PAIN INTENSITY, PAIN DURATION AND QUALITY OF LIFE. AUTHOR PEDro scale Mejora intensidad dolor Mejora duración dolor Mejora calidad de vida Ortiz MI et al(30) 9/10 X - - Shah S et al(37) 5/10 X - - Page 49 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 6" " Azima S et al(33) 7/10 X X - Yang NY et al(38) 5/10 X O - Azima S et al(32) 7/10 X X - Arora A et al(39) 5/10 X - X Patel NS et al(40) 4/10 X - - Sutar A et al(41) 3/10 X - X Yonglitthipagon P et al(31) 9/10 X - X Shirvani MA et al(34) 7/10 X O - Motahari-Tabari N et al(35) 7/10 O O - Abbaspour Z et al(26) 6/10 X X - Chaudhuri A et al(28) 7/10 O - O Nag U et al(42) 5/10 X - - Behbahani BM et al(27) 7/10 X X - Rakhshaee Z et al(36) 7/10 X X - X: significant differences in favor of “therapeutical exercise”. O: no significant differences in favor of “therapeutical exercise”. -: no data were collected. TABLE 4. INTERVENTIONS, OUTCOMES AND RESULTS. AUTHOR Intervention Evaluation PAIN INTENSITY PAIN DURATION QoL Ortiz MI (2015)(30) Experimental group: training program, 50 min/3 times a week. Physiotherapy program. Five phases: 5-10 repetitions. Ø 1st Phase: general stretches, 10 minutes. Ø 2nd Phase: specific stretches, 10 minutes. Stretches of the connective tissue around the pelvis, hip flexors and inner thigh muscles. 3 types of specific stretches. Ø 3rd Phase: trot, 10 minutes. At an intensity of between 60-70% of the máximum cardiac rate. Ø 4th Phase: Kegel exercises, 10 minutes. Involving contraction of the perineal musculature, 5 exercises proposed. Ø 5th Phase: relaxation exercises, 10 minutes. Supine with Deep breathing through the nose and expulsión through the mouth. Tool: VAS demographic questionnaire. Variables measured at the end of each period. During 3 periods. Significant differences in the second cycle and third cycle (p<0.05) in favor of the exercise group. Control group: VAS-baseline = 62.9 ± 1.5 Experimental group: VAS-baseline = 64.9 ± 1.3 Post-interventions means and standard deviations - - Page 50 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 7" " Control group: wait in the yard; standing, walking or talking. They do not perform stretching, Kegel exercises, yoga or relaxation exercises. not provided. Shah S (2016)(37) Between December 2014 to April 2015. Group A (experimental): Ø 6 activities: abdominal, pelvic and inguina stretches. Ø For 8 weeks: 4 days a week. Ø No stretches during cycles. Group B (control): waiting period for 8 weeks. Questionnaire for menstruation and dysmenorrhea characteristics. Tool: VAS and Verbal Multidimensional Scoring System (VMSS) Control group: Pretest: 6.5±0.76 Postest: 6.4±0.75 Experimental group: Pretest: 6.3±1.22 Postest: 4.6±0.99 W group A: 171 W group B: 9 Pre-post (intragroup) comparison: Control group: p = 0.53 Experimental group: p = 0.0002 Comparison of difference in VAS between Groups: p < 0.0001 - - Azima S (2015)(33) Between November 2012 to May 2013. Experimental group: Perform isometrics on the 3rd day of menstration. Ø 5 days a week, 2 sessions a day. Ø 10 repetitions per session for 8 weeks. . ◦ 7 positions modified and confirmed by a specialized rehabilitator. ◦Isometric protocol. Control group: non-intervention. 1st month non-intervention: measurement of intensity, pain duration and anxiety in both. 2nd month: questionnaire in control and intervention program. Tools: VAS, pain hours, Spilerger quiestionnaire. (Anxiety level) Measurements at the end of the 1st, 2nd and 3rd cycle in both groups. Control group: 1st month: 6.61±2.04 2nd month: 6.941±1.94 3rd month: 6.67±1.96 Exercise group: 1st month: 6.58±1.67 2nd month: 4.64±2.60 3rd month: 4.17±2.12 Intragroup comparison: Control: p = 0.598 Exercise p < 0.001 Between groups comparison 1st month: p = 0.948 2nd month p <0.001 3rd month p <0.001 Control group: 1st month: 7.91±5.24 2nd month: 7.67±5.49 3rd month: 8.35±6.03 Exercise group: 1st month: 10.70±7.63 2nd month: 9.63±7.17 3rd month: 5.29±4.77 Intragroup comparison: Control: p = 0.562 Exercise p < 0.001 Between groups comparison 1st month: p = 0.083 2nd month: p = 0.793 3rd month: p = 0.024 - Yang NY (2016)(38) Ø Diagnosis by a specialist. Two groups: experimental and control. Experimental: 12 week yoga program. Program guided by a certified yoga specialist: ◦ 10 cycles of surya namaskara for 15 min. ◦ 5 min shavasana of relaxation. ◦ 5 cycles: cat, cobra and fish, 10 min. Before the program: menstrual and demographic information, VAS, pain duration, Short Form Menstrual Distress Questionnaire Control group: Pre-test: 7.00±0.77 Week 12: 6.89±0.83 Control group: Pre-test: 1.94±0.64 Week 12: 1.83±0.62 - Page 51 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 8" " ◦ 30 min yoga nidra. ◦ Do not perform other yoga activities. ◦ Avoid contact with the control group. Control group: did not participate in the program. (SF-MDQ). After the program: VAS, pain duration, SF-MDQ. Exercise group: Pre-test: 7.33±0.69 Week 12: 5.49±0.73 Intragroup comparison: Control: p > 0.05 Exercise: p < 0.0001 Between groups comparison Pre-test: p = 0.053 Week 12: p = 0.001 Exercise group: Pre-test: 1.89±0.58 Week 12: 1.67±0.69 Intragroup comparison: Control: p > 0.05 Exercise p < 0.05 Between groups comparison Pre-test: p = 0.002 Week 12: p = 0.449 Azima S (2015)(32) Ø Massage group: skin sensitivity test. ◦Supine. ◦ Upper pubic symphysis and navel (15 min each). ◦ Pain duration and intensity measured after massage ◦ Anxiety levels, 24 hours after the second massage. Ø Exercise group: isometrics 3rd day of the cycle. ◦ 5 days/week, 2 sessions/day. ◦ 10 repetitions, 8 weeks. ◦ Pain intensity and duration in 3 consecutive cycles. ◦ Anxiety levels in 4th and 8th week after exercise. Ø Control group: non-intervention. ◦ Intensity, duration and anxiety levels at the end of the 4th and 8th week after the cycle Questionnaire for anxiety levels. Measurements before the intervention. Pain intensity and duration was measured in the 3 intervention groups in 3 consecutive menstrual cycles. Control group: 1st month (before the intervention): 6.61±2.04 2nd month: 6.94±1.94 3rd month:: 6.67±1.96 Massage group: 1st month (before the intervention): 7.05±1.85 2nd month: 4.26±2.59 3rd month:: 3.44±1.86 Exercise group: 1st month (before the intervention): 6.58±1.67 2nd month: 4.64±2.60 3rd month:: 4.17±2.02 Intragroup comparison: Control: p = 0.598 Massage: p < 0.001 Exercise: p < 0.001 Between groups comparison: 1st month: p = 0.509 2nd month p <0.001 3rd month p <0.001 Control group: 1st month (before the intervention): 7.91±5.24 2nd month: 7.67±5.49 3rd month:: 8.35±6.03 Massage group: 1st month (before the intervention): 9±6.57 2nd month: 5.97±4.96 3rd month:: 4.73±3.58 Exercise group: 1st month (before the intervention): 10.7±7.63 2nd month: 9.63±7.17 3rd month:: 5.29±4.77 Intragroup comparison: Control: p = 0.562 Massage: p < 0.001 Exercise: p < 0.001 Between groups comparison 1st month: p = 0.214 2nd month p = 0.590 3rd month p = 0.006 - Arora A (2014)(39) Experimental group: aerobic exercise program for 3 months. ◦ 10 min warm up. ◦ 30 min aerobic phase (74-84% FCM). ◦ 10 min cooling off. Questionnaire: medical, sociodemographic, ability and state of dysmenorrhoea characteristics, EVA, non-use of compresses during the maximum bleeding day, MDS and quality of life Control group: Pretest: 8.20+0.71 Difference Between Pre & Post: -0.13±0.93 Experimental group: Pretest: 7.93+0.86 - Control group: Difference Between Pre-Post: 2.99+4.88 Experimental group: Difference Between Page 52 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 9" " ◦3-5 times/week. 12 weeks of intervention Control group: without intervention. through the SF-36 questionnaire. Administration of the dysmenorrhea questionnaire before the intervention and after this collection of results. Difference Between Pre & Post: 2.60±1.5 Between groups comparison: Pretest: p = 0.163 Difference Between Pre & Post: p <0.0001 Pre-Post:14.36+11.3 Patel NS (2015)(40) Experimental group: Stretches for 8 weeks. ◦ 6 types of stretching. ◦ 3 days/week, twice/day, 8 weeks. ◦ Do not perform stretches during the period. Control group: do not perform any type of exercise. Measurements before the beginning of the program, after 4 weeks and after 8 weeks. Tools: VAS, Moos' Menstrual Distress Questionnaire (menstrual symptoms) Control group: Pretest: 7.417±1.418 8 week: 7.2±1.436 Experimental group: Pretest: 7.133±1.467 8 week: 3.017±0.9654 Between groups comparison: Pretest: p = 0.0367 8 week: p<0.0001 - - Sutar A (2016)(41) 8 weeks aerobic exercise: 3 days/week, 45 minutes/day. 3 cycles. ◦ 10 min heating. ◦ 25 min, 70-80% Borg scale aerobic exercise. Dance. ◦ 10 min cooling Control group: observation without exercises or lifestyle modification. Evaluation questionnaire, VAS, MSS (degree of dysmenorrhea), SF-36 (quality of life) Pain measurement at the onset and the three consecutive cycles. ◦ 24-36 hours menstruation start. ◦ Pre-intervention (4th week) and postintervention (8th week). P<0.05 in favor of the exercise group. Pre and Postinterventions means and standard deviations not provided. - When the eight domains of the SF-36 were compared between the first and third visits, all domains showed highly significant improvement within the group (pre and post intervention). The Physical Domain of Quality of life showed significant difference in the exercise group. Pre and Postinterventions means and standard deviations not provided. Yonglitthipagon P (2017)(31) 12 weeks, February 2015—January 2016 Yoga group: 30 min before breakfast/dinner or 2 h after (shavasana, surya namaskar, supta vajrasana, janu sirsasana, pashimottanasana). Yoga teacher and home. Control group: nothing. 10 minutes telephone follow-ups to control Tools: VAS, SF-36 Measurement: On starting and at 12 weeks. Adjusted Means of Variable Measures after 12-week Experimental Setup Control: 4.17 Yoga: 2.30 Between groups comparison p=0.02 - Adjusted Means of Variable Measures after 12-week Experimental Setup SF-36 Functional capacity Control: 79.19 Yoga: 88.16 Page 53 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 10" " p=0.049 Physical limitation Control: 88.15 Yoga: 95.67 p=0.241 Emotional limitation Control: 82.35 Yoga: 88.24 p= 0.527 Vitality Control: 53.02 Yoga: 69.04 p<0.0001 Mental health Control: 59.45 Yoga: 73.73 p<0.0001 Social aspects Control: 69.17 Yoga: 83.78 p<0.0001 Pain Control: 69.13 Yoga: 82.79 p=0.008 General health Control: 53.14 Page 54 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 11" " Yoga: 71.27 p<0.0001 Motahari-Tabari N (2017)(35) Five months in 2014. Experimental group: 1. 5 min warm-up standing 2. 10 min six belly and pelvic stretching exercises 15 minutes, 3 times/week, 2 menstrual cycles (8 weeks). Not during menstruation. Two trained instructors taught exercise. Mefenamic acid (MA) group: 250mg capsules every 8 h from the onset of menstruation until pain relief, 2 cycles. VAS for pain intensity at the end of the first and second menstrual cycles. Control group (MA): At baseline: 55.0±20.4 1st cycle: 39.0±17.8 2nd cycle: 33.8±17.7 Experimental group: At baseline: 60.3±14.5 1st cycle: 45.4±19.2 2nd cycle: 31.6±16.03 Between groups comparison: At baseline: p=0.104 1st cycle: p=0.058 2nd cycle: p=0.477 Control group (MA): At baseline: 1.7±0.9 1st cycle: 1.4±0.6 2nd cycle: 1.6±0.7 Experimental group: At baseline: 1.8±0.7 1st cycle: 1.6±0.8 2nd cycle: 1.5±0.7 Between groups comparison: At baseline: p=0.444 1st cycle: p=0.131 2nd cycle: p=0.378 - Chaudhuri A (2013)(28) April 2010 — September 2010 Intervention group: physical education teacher and doctor. Practised except on the days of menstruation, two sessions/day, 10-15 minutes. 1. Lie face up with legs and knees semiflexed, abdominal breathing. 10 times. 2. Lie on back, bring knees to touch chin, straighten back the legs. 10 times. 3. Stand straight while holding the back of a chair, stand on toes for 10 seconds (heels raised), normal positions. 20 times. 4. Stand straight while holding the back of a chair, do 5 deep knee bends, 15 seconds. 5. Stand with both knees semi-flexed and feet together. Hold a roll in the back of both knees, 1 minute. Once a week visits to repeat demonstrations. Initial training for 40-45 minutes, subsequent of 15-20 minutes. Control Group: Hot Water Bottle (HWB). Bottles wrapped in towels, applied over the lower abdomen, 15-20 minutes. Control by phone calls mothers. MDQ for severity of dysmenorrhea and impact on life (18 questions). VAS for intensity of pain (0-10). Post intervention assessment: 1st, 2nd and 3rd months after beginning interventions. Control group: Baseline: 5.16 (CI: 4.8- 5.51) 1st month: 3.55 (CI: 3.14-3.95) 2nd month: 2.70 (CI: 2.34-3.05) 3rd month: 2.06 (CI: 1.74-2.37) Experimental group: Baseline: 5.75 (CI: 5.13- 6.36) 1st month: 4.36 (CI: 3.79-4.93) 2nd month: 3.46 (CI: 2.86-4.06) 3rd month: 2.96 (CI: 2.36-3.56) Intragroup comparison: Control: Baseline-1st month: p<0.001 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 - Control group: Baseline: 14.92 (CI: 12.36-17.48) 1st month: 11.45 (CI: 9.26-13.63) 2nd month: 9.91 (CI: 7.22-12.59) 3rd month: 8.16 (CI: 5.40-10.91) Experimental group: Baseline: 14.53 (CI: 11.39-17.66) 1st month: 14.11 (CI: 10.42-17.79) 2nd month: 9.02 (CI: 6.60-11.43) 3rd month: 7.85(5.34- 10.53) Intragroup comparison: Control: Baseline-1st month: p<0.001 Baseline-2nd month: p<0.001 Baseline-3rd month: Page 55 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60
For Peer Review Only 12" " Exercise: p < 0.001 Baseline-1st month: p<0.001 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 Between groups comparison: Baseline: p = 0.086 1st month: p = 0.022 2nd month: : p = 0.028 3rd month: : p = 0.007 p<0.001 Exercise: p < 0.001 Baseline-1st month: p=0.669 Baseline-2nd month: p<0.001 Baseline-3rd month: p<0.001 Between groups comparison: Baseline: p = 0.849 1st month: p = 0.203 2nd month: : p = 0.645 3rd month: : p = 0.878 Shirvani MA (2017)(34) January — May 2014. Experimental group: two trained instructors, practices with students: 1. 5 min of warm-up in standing position 2. 6 stretching exercises for the abdomen and pelvis for 10 minutes 15 min, 3 times/week, two consecutive menstrual cycles (8 weeks), not during menstruation. Control weekly. Ginger group (Control group): 250mg ginger capsules, at the onset of menstruation and every 6h until pain relief for 2 cycles. VAS to pain intensity. Other characteristics: pain duration, length of menstruation, menstrual cycle, change in bleeding) Record: at the end of the first and the second menstruation cycles. Control group: Baseline: 58.01±15.15 1st month: 43.49±19.99 2nd month: 38.19±20.47 Experimental group: Baseline: 60.26±14.45 1st month: 45.42±19.21 2nd month: 31.57±16.03 Intragroup comparison: Control group Baseline-1st and 2nd month: p < 0.0001 Experimental group Baseline-1st and 2nd month: p < 0.0001 Between groups comparison: Changes between baseline and 1st month p = 0.95 Changes between baseline and 1st month p = 0.02 Control group: Baseline: 1.62±0.85 1st month: 1.60±0.80 2nd month: 1.49±0.78 Experimental group: Baseline: 1.78±0.70 1st month: 1.59±0.78 2nd month: 1.50±0.72 Intragroup comparison Control group Baseline-1st and 2nd month: p = 0.69 Experimental group Baseline-1st and 2nd month: p = 0.02 Between groups comparison: Changes between baseline and 1st month p = 0.12 Changes between baseline and 1st month p = 0.16 - Nag U (2013)(42) From July to October 2010. 18-23 years. Yoga intervention: 24 yoga poses (navasana, matsyasana, dhanurasana, vajrasana, paschimotasana, ustrasana, ardhamatstyendrasana, salabhasana, bhujangasana sarvangasana, uttanapadasana, padmasana, and surya namaskara). Control group: nothing NRS (0-10) for pain intensity and PSS for stress (both). Both groups evaluated after three months. Control Group (53 subjects): Baseline: 2 mild pain, 44 reported mild to moderate pain, 9 severe pain. After 3 months: no change was observed in 52 subjects. - - Page 56 of 59 PTJ Manuscript in Review Physical Therapy 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60