Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea
ConditionDysmenorrhea Primary
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-30
SponsorIstanbul Medipol University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Secondary dysmenorrhea.
Diagnosis of endometriosis, uterine fibroids, ovarian cysts, or pelvic inflammatory disease.
History of gynecological surgery.
Pregnancy or suspected pregnancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Vibration Therapy Group
DeviceVibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks.
Abdominal Massage
Other interventionA 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 interventionManual 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 interventionStandardized 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.
Treatment groups
96 Participants
are divided into 4 treatment groupsGroup A: Vibration Therapy GroupExperimental treatment 2 interventions
Group B: Abdominal Massage GroupExperimental treatment 2 interventions
Group C: Myofascial Release GroupExperimental treatment 2 interventions
Group D: Education Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and post-intervention at Week 12Secondary outcomes
1
Change in Short-Form McGill Pain Questionnaire Sensory Subscore
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.
Time frame
Baseline and post-intervention at Week 122
Change in Short-Form McGill Pain Questionnaire Affective Subscore
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.
Time frame
Baseline and post-intervention at Week 123
Change in Pressure Pain Threshold Measured by Algometry
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.
Time frame
Baseline and post-intervention at Week 124
Change in Menstrual Symptom Questionnaire Mean Total Score
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.
Time frame
Baseline and post-intervention at Week 12Sponsors and contacts
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Source ClinicalTrials.gov