Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07731243

Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea

This randomized, assessor-blinded, four-arm, parallel-group controlled trial aims to compare the effects of vibration therapy, abdominal massage, and myofascial release with an education-only control intervention in women with primary dysmenorrhea. Seventy-two women aged 18 to 30 years will be randomized in a 1:1:1:1 ratio. All participants will receive standard education about primary dysmenorrhea. The three intervention groups will additionally receive their assigned treatment twice weekly for 12 weeks, covering three menstrual cycles. Menstrual pain, pain characteristics, pressure pain threshold, menstrual symptoms, and symptoms associated with central sensitization will be evaluated at baseline and after the intervention by a blinded assessor.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, 34815, Turkey (Türkiye)

Location status: Recruiting

Location contact

Gizem Boztaş Elverişli

CONTACT

[email protected]

05439076494 ext. 90 5439076494

About this study

Primary dysmenorrhea is a common condition characterized by menstrual pain that may negatively affect daily activities and school or work performance. This study will investigate three non-pharmacological treatment approaches for managing primary dysmenorrhea.

A total of 72 women aged 18 to 30 years with primary dysmenorrhea will be randomly assigned in a 1:1:1:1 ratio to one of four groups: vibration therapy, abdominal massage, myofascial release, or education-only control. All participants will receive standardized education about primary dysmenorrhea and menstrual pain management.

The vibration therapy group will receive treatment using a vibrating massage ball applied to the abdominal and lumbosacral regions. The abdominal massage group will receive standardized massage applied to the lower abdominal and suprapubic regions. The myofascial release group will receive treatment targeting the abdominal, lumbopelvic, and sacral regions. The control group will receive education only. The interventions will be administered twice weekly for 12 weeks, covering three menstrual cycles.

Assessments will be conducted at baseline and after the 12-week intervention. Outcomes will include menstrual pain characteristics, pressure pain threshold measured by algometry at six standardized anatomical points, menstrual symptoms, and symptoms associated with central sensitization. Outcome assessments will be performed by an assessor blinded to group allocation.

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion Criteria:
  • Female participants aged 18 to 30 years.
  • Having regular menstrual cycles during the previous 6 months.
  • Having a diagnosis consistent with primary dysmenorrhea following evaluation by an obstetrician and gynecologist.
  • Experiencing menstrual pain in at least 2 of the previous 3 menstrual cycles.
  • Having menstrual pain intensity of 4 or higher on a 0-10 Visual Analog Scale.
  • Voluntarily agreeing to participate in the study and providing written informed consent.

Exclusion criteria

  • Secondary dysmenorrhea.
  • Diagnosis of endometriosis, uterine fibroids, ovarian cysts, or pelvic inflammatory disease.
  • History of gynecological surgery.
  • Pregnancy or suspected pregnancy.
  • Having given birth within the previous 6 months.
  • Recent initiation of hormonal treatment.
  • Chronic pelvic pain or a neurological, rheumatological, or systemic inflammatory disease.
  • Having received manual therapy or physiotherapy targeting the abdominal or lumbopelvic region within the previous 3 months.
  • Skin lesions, infection, open wounds, or other dermatological conditions in the treatment regions.
  • Any clinical condition considered a contraindication to vibration therapy.
  • Inability to comply with the study protocol -

Treatment and study plan

Vibration Therapy Group

Device

Vibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks.

Abdominal Massage

Other

A standardized abdominal massage protocol will be applied manually to the lower abdominal and suprapubic regions. The intervention will be delivered twice weekly for 12 weeks.

Myofascial Release

Other

Manual myofascial release techniques will be applied to the abdominal, lumbopelvic, and sacral regions using a standardized treatment protocol. The intervention will be delivered twice weekly for 12 weeks.

Education

Other

Standardized education will include information about menstrual pain management, considerations during daily activities, and general non-pharmacological approaches. The same education will be provided to participants in all four study arms.

Primary outcomes

  1. Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score

    Time frame: Baseline and post-intervention at Week 12

    The SF-MPQ consists of 15 pain descriptors, including 11 sensory and 4 affective items. Each item is rated from 0 (none) to 3 (severe). Item scores are summed to obtain a total score ranging from 0 to 45. Higher scores indicate greater pain severity. The change in total score from baseline to Week 12 will be compared among the study groups.

Secondary outcomes

  1. Change in Short-Form McGill Pain Questionnaire Sensory Subscore

    Time frame: Baseline and post-intervention at Week 12

    The sensory component of the SF-MPQ consists of 11 pain descriptors. Each item is rated from 0 (none) to 3 (severe), producing a sensory subscore ranging from 0 to 33. Higher scores indicate more severe sensory pain. The change from baseline to Week 12 will be compared among the study groups.

  2. Change in Short-Form McGill Pain Questionnaire Affective Subscore

    Time frame: Baseline and post-intervention at Week 12

    The affective component of the SF-MPQ consists of 4 pain descriptors. Each item is rated from 0 (none) to 3 (severe), producing an affective subscore ranging from 0 to 12. Higher scores indicate more severe affective pain. The change from baseline to Week 12 will be compared among the study groups.

  3. Change in Pressure Pain Threshold Measured by Algometry

    Time frame: Baseline and post-intervention at Week 12

    Pressure pain threshold is defined as the minimum amount of pressure at which the sensation of pressure first becomes painful. Measurements will be obtained using a pressure algometer at six standardized anatomical points in the abdominal, lumbopelvic, and sacral regions. Each measurement point will be recorded and analyzed separately. Higher values indicate lower mechanical pain sensitivity.

  4. Change in Menstrual Symptom Questionnaire Mean Total Score

    Time frame: Baseline and post-intervention at Week 12

    The Menstrual Symptom Questionnaire consists of 22 items rated on a 5-point scale from 1 (never) to 5 (always). The mean total score is calculated by averaging the scores of all items and ranges from 1 to 5. Higher scores indicate greater severity and frequency of menstrual symptoms. The change from baseline to Week 12 will be compared among the study groups.

  5. Change in Central Sensitization Inventory Total Score

    Time frame: Baseline and post-intervention at Week 12

    The Central Sensitization Inventory Part A consists of 25 items assessing symptoms associated with central sensitization. Each item is rated from 0 (never) to 4 (always), producing a total score ranging from 0 to 100. Higher scores indicate a greater burden of symptoms associated with central sensitization. The change from baseline to Week 12 will be compared among the study groups.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Comparison of Vibration Therapy, Classical Abdominal Massage, and Myofascial Release Applications in Primary Dysmenorrhea

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 28, 2026
Registry last updated
Jul 28, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.