An interventional study of Vibration Therapy Group and Abdominal Massage in Dysmenorrhea Primary, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Other
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.
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.
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 96 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →Istanbul Medipol University Hospital is the lead sponsor of 366 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
Vibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks.
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.
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.
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.
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 12
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 12
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 12
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 12
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 12
Change in Central Sensitization Inventory Total Score
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.
Time frame: Baseline and post-intervention at Week 12
Plan to share: Undecided
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