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Completed

NCT Number: NCT07335926

Tele-Pilates for Primary Dysmenorrhea

This randomized controlled trial investigates the effectiveness of a synchronized tele-Pilates program on menstrual pain, symptom severity, physical disability, and trunk muscle endurance in women with primary dysmenorrhea (PD). The intervention includes 16 supervised online Pilates sessions delivered over eight weeks.

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Key information

Conditions

Primary Dysmenorrhea Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Atlas University

Istanbul, Kağıthane, 34413, Turkey (Türkiye)

About this study

Primary dysmenorrhea is a prevalent gynecological condition characterized by painful menstruation. Exercise, particularly core stabilization and mind-body methods like Pilates, may improve both physical and psychological symptoms associated with PD. In this single-center RCT, 34 women aged 18-35 with PD were randomized to either a Tele-Pilates group or a control group. The Pilates group received supervised online sessions twice weekly for 8 weeks. Outcomes included pain severity (VAS), symptom burden (MSQ), functional impairment (FEMD), disability (Oswestry LBP Index), and trunk muscle endurance (McGill tests). Findings demonstrated significant improvements in the Pilates group across all domains.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18-35 years
  • Regular menstrual cycles (28±7 days)
  • VAS ≥5 for menstrual pain
  • Diagnosed with primary dysmenorrhea

Exclusion criteria

  • Secondary dysmenorrhea (e.g., endometriosis, fibroids)
  • Pregnancy or use of intrauterine devices
  • Significant comorbidities (e.g., spondylolisthesis)

Treatment and study plan

Tele-Pilates Exercise program

Other

The intervention consisted of a synchronous, supervised tele-Pilates exercise program delivered via video conferencing platforms twice per week for 8 weeks. Each session lasted approximately 50 minutes and followed clinical Pilates principles based on the APPI method. The program emphasized core activation, diaphragmatic breathing, pelvic alignment, and trunk stabilization through progressively structured movements. Real-time feedback from a physiotherapist ensured correct execution, adaptation to individual capacity, and consistent adherence. The exercise protocol also incorporated components such as pelvic floor activation, transversus abdominis training, and guided relaxation.

standardized menstrual health education online

Behavioral

The education module consisted of two 45-minute interactive sessions conducted by a physiotherapist and covered the physiology of the menstrual cycle, pathophysiology of primary dysmenorrhea, common symptoms, and non-pharmacological management strategies. Content also included lifestyle modifications such as hydration, nutrition, physical activity, stress reduction techniques, and proper menstrual hygiene practices. Educational materials were adapted from current evidence-based guidelines and delivered using digital slides and discussion-based formats to promote participant engagement and understanding.

Primary outcomes

  1. Menstrual pain severity

    Time frame: Change from baseline to post-intervention (8 weeks)

    Menstrual pain severity was assessed using a 10 cm Visual Analog Scale, where participants marked the most intense pain experienced during their last menstrual cycle.

Secondary outcomes

  1. Menstrual symptom severity (Menstrual Symptom Questionnaire total score)

    Time frame: Change from baseline to post-intervention (8 weeks)

    The Menstrual Symptom Questionnaire is a 24-item self-report measure assessing the severity of menstrual-related symptoms across emotional, physical, and pain domains; each item is rated on a 5-point Likert scale (1 = never to 5 = always), yielding a total score range of 24 to 120, where higher scores indicate worse symptom severity.

  2. Functional and emotional burden (Functional and Emotional Measure of Dysmenorrhea total score)

    Time frame: Change from baseline to post-intervention (8 weeks)

    Functional and Emotional Measure of Dysmenorrhea (FEMD) is a 14-item self-report scale assessing the functional and emotional impact of dysmenorrhea, with each item rated on a 5-point Likert scale (1 = not at all similar to my situation to 5 = very similar to my situation), yielding a total score range of 14 to 70, where higher scores indicate greater functional and emotional impairment.

  3. Trunk muscle endurance (McGill tests: flexor muscles)

    Time frame: Change from baseline to post-intervention (8 weeks)

    Endurance of trunk flexor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.

  4. Trunk muscle endurance (McGill tests: extensor muscles)

    Time frame: Change from baseline to post-intervention (8 weeks)

    Endurance of trunk extensor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.

  5. Trunk muscle endurance (McGill tests: lateral flexor muscles)

    Time frame: Change from baseline to post-intervention (8 weeks)

    Endurance of trunk lateral flexor muscles was measured using McGill's standardized core endurance test protocol, with duration recorded in seconds.

  6. Disability due to low back pain (Oswestry Index)

    Time frame: Change from baseline to post-intervention (8 weeks)

    The Oswestry Disability Index was used to measure functional disability related to low back pain, commonly accompanied by dysmenorrhea, a 10-item scale. Each item is scored from 0 to 5, resulting in a total score range of 0 to 50, where higher scores indicate greater levels of disability and functional limitation.

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Tele-Pilates for Primary Dysmenorrhea: A Randomized Controlled Trial on Pain, Symptoms, and Trunk Endurance

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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