Menstrual pain and quality of life in women with primary dysmenorrhea: Rationale, design, and interventions of a randomized controlled trial of effects of a treadmill-based exercise intervention

Dysmenorrhea in the absence of pelvic abnormality is termed primary dysmenorrhea (PD). The health burden and social and economic costs of PD are high as it is reported to be the leading cause of recurrent absenteeism from school or work in adolescent girls and young adults. The belief that exercise works for relieving symptoms in women with PD is based on anecdotal evidence and non-experimental studies. There is very limited evidence from randomized controlled trials (RCTs) to support the use of exercise to reduce the intensity of menstrual pain. The objective of this study is to evaluate the effectiveness of exercise to reduce intensity of pain and improve quality of life in women with PD. We describe the study design of a single-blind (assessor), prospective, two-arm RCT, and the participant characteristics of the 70 women recruited in the age-group 18 to 43 years. The primary outcome of the study is pain intensity. The secondary outcomes of the study are quality of life, functional limitation, sleep, global improvement with treatment, and protocol adherence. The outcomes assessments are done at first menstrual period (baseline, Week 0), 2nd menstrual period (Week 4) and at two additional time points (Week 16 and Week 28) during the trial. The results of the study will provide physiotherapists, medical practitioners, and researchers as well as the women who have PD with new insights, knowledge, and evidence about the use of exercise to manage pain in women with PD. (C) 2015 Elsevier Inc. All rights reserved.