Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea

NCT07731243 | Recruiting

• 1 other identifier: E-10840098-50.04-4782
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysmenorrhea Primary

Keywords

Primary dysmenorrhea; menstrual pain; vibration therapy; abdominal massage; myofascial release

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline and post-intervention at Week 12

Secondary Outcomes (5)

• Change in Short-Form McGill Pain Questionnaire Sensory Subscore

  Baseline and post-intervention at Week 12

• Change in Short-Form McGill Pain Questionnaire Affective Subscore

  Baseline and post-intervention at Week 12

• Change in Pressure Pain Threshold Measured by Algometry

  Baseline and post-intervention at Week 12

• Change in Menstrual Symptom Questionnaire Mean Total Score

  Baseline and post-intervention at Week 12

• Change in Central Sensitization Inventory Total Score

  Baseline and post-intervention at Week 12

Study Arms (4)

Vibration Therapy Group

EXPERIMENTAL

Participants will receive standardized education on primary dysmenorrhea and vibration therapy using a vibrating massage ball applied to the abdominal and lumbosacral regions. The intervention will be administered twice weekly for 12 weeks, covering three menstrual cycles.

Device: Vibration Therapy Group; Other: Education

Abdominal Massage Group

EXPERIMENTAL

Participants will receive standardized education on primary dysmenorrhea and abdominal massage applied to the lower abdominal and suprapubic regions using standardized massage techniques. The intervention will be administered twice weekly for 12 weeks, covering three menstrual cycles.

Other: Abdominal Massage; Other: Education

Myofascial Release Group

EXPERIMENTAL

Participants will receive standardized education on primary dysmenorrhea and myofascial release applied to the abdominal, lumbopelvic, and sacral regions. The intervention will be administered twice weekly for 12 weeks, covering three menstrual cycles.

Other: Myofascial Release; Other: Education

Education Control Group

ACTIVE COMPARATOR

Participants will receive standardized education on primary dysmenorrhea and menstrual pain management, including information about daily activities and non-pharmacological approaches. No additional vibration-based or manual treatment will be administered during the 12-week study period.

Other: Education

Interventions

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.

Vibration Therapy Group

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.

Abdominal Massage Group

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.

Myofascial Release Group

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.

Abdominal Massage Group; Education Control Group; Myofascial Release Group; Vibration Therapy Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Istanbul, 34815, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Myofascial Release Therapy; Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

TU (1)