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NCT07731243

Overview

NCT ID: NCT07731243
Lead Sponsor: Istanbul Medipol University HospitalOTHER
Official Title: Comparison of Vibration Therapy, Classical Abdominal Massage, and Myofascial Release Applications in Primary Dysmenorrhea
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

Status and Timeline

Status: Recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Jul 14, 2026Actual
Primary Completion Date: Nov 15, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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 -

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 96Estimated
Primary Purpose: Other
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: Istanbul Medipol University

Similar Studies

Participant Group/Arms

Vibration Therapy GroupExperimental

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 GroupExperimental

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

Myofascial Release GroupExperimental

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

Education Control GroupActive 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