Dysmenorrhea Primary
Conditions
Keywords
Primary dysmenorrhea, menstrual pain, vibration therapy, abdominal massage, myofascial release
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.
Detailed description
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.
Interventions
DEVICEVibration Therapy Group
Vibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks.
OTHERAbdominal Massage
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.
OTHERMyofascial Release
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.
OTHEREducation
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.
Sponsors
Istanbul Medipol University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
No
Inclusion 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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Short-Form McGill Pain Questionnaire Sensory Subscore | 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. |
| Change in Short-Form McGill Pain Questionnaire Affective Subscore | 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. |
| Change in Pressure Pain Threshold Measured by Algometry | 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. |
| Change in Menstrual Symptom Questionnaire Mean Total Score | 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. |
| Change in Central Sensitization Inventory Total Score | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed