Dysmenorrhea PrimaryNCT07731243
Vibration, Massage, and Myofascial Release in Primary Dysmenorrhea
A study testing Vibration Therapy Group, Abdominal Massage and Myofascial Release in people with Dysmenorrhea Primary, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Vibration Therapy Group, Abdominal Massage and Myofascial Release
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2026to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medipol University
Istanbul, Istanbul, 34815
Gizem Boztaş Elverişli, 05439076494 ext. 90 5439076494, gboztas@medipol.edu.tr
About this study
Official title: Comparison of Vibration Therapy, Classical Abdominal Massage, and Myofascial Release Applications in Primary Dysmenorrhea
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.
Read the 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.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Vibration Therapy Group, Abdominal Massage, Myofascial Release, Education
- Keywords
- Primary dysmenorrhea, menstrual pain, vibration therapy, abdominal massage, myofascial release
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibration Therapy GroupDevice
Vibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks.
Abdominal MassageOther
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.
Myofascial ReleaseOther
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.
EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and post-intervention at Week 12
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and post-intervention at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start14 Jul 2026
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, gizem boztas, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731243
- Sponsor's protocol ID
- E-10840098-50.04-4782
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vibration Therapy, Classical Abdominal Massage, and Myofascial Release Applications in Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07731243
- Acronym / sponsor ID
- E-10840098-50.04-4782
- Conditions
- Dysmenorrhea Primary
- Keywords
- Primary dysmenorrhea, menstrual pain, vibration therapy, abdominal massage, myofascial release
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vibration Therapy Group | Experimental | Device: Vibration Therapy Group, Other: EducationParticipants 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. |
| Abdominal Massage Group | Experimental | Other: Abdominal Massage, Other: EducationParticipants 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. |
| Myofascial Release Group | Experimental | Other: Myofascial Release, Other: EducationParticipants 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. |
| Education Control Group | Active comparator | Other: EducationParticipants 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibration Therapy GroupVibration will be applied to the abdominal and lumbar-sacral regions. This treatment will be performed twice a week for 12 weeks. | Device | Vibration Therapy Group |
| Abdominal MassageA 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. | Other | Abdominal Massage Group |
| Myofascial ReleaseManual 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. | Other | Myofascial Release Group |
| EducationStandardized 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. | Other | Abdominal Massage Group, Education Control Group, Myofascial Release Group, Vibration Therapy Group |
Primary outcome
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score
Time frame: 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.
5 secondary outcomes
Change in Short-Form McGill Pain Questionnaire Sensory Subscore
Time frame: Baseline and post-intervention at Week 12
Change in Short-Form McGill Pain Questionnaire Affective Subscore
Time frame: Baseline and post-intervention at Week 12
Change in Pressure Pain Threshold Measured by Algometry
Time frame: Baseline and post-intervention at Week 12
Change in Menstrual Symptom Questionnaire Mean Total Score
Time frame: Baseline and post-intervention at Week 12
Change in Central Sensitization Inventory Total Score
Time frame: Baseline and post-intervention at Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration Therapy Group, Abdominal Massage and Myofascial Release in people with Dysmenorrhea Primary, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score (time frame: Baseline and post-intervention at Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.