Spinal manipulation and massage for menstrual symptoms and sleep in women with dysmenorrhea
The Effects of Spinal Manipulation on Menstrual Symptoms, Pain Severity, and Sleep Quality in Individuals with Primary Dysmenorrhea
This study is testing if a combination of spinal manipulation and massage can help women with painful periods feel better and sleep more soundly.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 2 sites (Istanbul and 1 other locations) |
| Trial ID | NCT06673537 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of spinal manipulation combined with connective tissue massage in improving pain, menstrual symptoms, depression levels, and sleep quality in women suffering from primary dysmenorrhea. Participants will be divided into three groups: one receiving the combined treatment, another receiving a sham treatment, and a control group with no intervention. The study aims to determine if these therapies can significantly alleviate symptoms associated with primary dysmenorrhea over a six-week period. By focusing on both pain management and overall quality of life, the research seeks to provide a comprehensive rehabilitation strategy for affected individuals.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of primary dysmenorrhea and regular menstrual cycles.
Not a fit: Patients with gastrointestinal, urogenital, autoimmune, or psychiatric disorders, as well as those with chronic pain syndromes or irregular menstrual cycles, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-pharmacological treatment option for women suffering from primary dysmenorrhea, improving their quality of life.
How similar studies have performed: While the integration of spinal manipulation and connective tissue massage is a novel approach, similar studies have shown promise in using manual therapies for pain relief in various conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being 18 years or older, * Having primary dysmenorrhea according to the criteria specified in the Primary Dysmenorrhea Consensus Guide (1. Onset of pain 6 to 24 months after menarche, 2. Pain lasting between 8 to 72 hours, and 3. The most intense pain occurring on the 1st and/or 2nd day of menstruation), * Having a regular menstrual cycle (28 ± 7 days). Exclusion Criteria: * Having gastrointestinal, urogenital, autoimmune, or psychiatric disorders (serious psychiatric disorders that would prevent participation in the study), * Having other chronic pain syndromes, * Having given birth or a positive pregnancy test, * Using an intrauterine device (IUD), * Having undergone pelvic surgery, * Having used chronic medications, including oral contraceptives or antidepressants, within at least 6 months prior to the study, * Having irregular menstrual cycles (shorter than 21 days or longer than 35 days, and/or a cycle variation exceeding 4 days), * Having a history of pathological conditions indicating secondary dysmenorrhea.
Where this trial is running
Istanbul and 1 other locations
- Istanbul University-Cerrahpasa — Istanbul, Turkey (Recruiting)
- IstanbulUC — Istanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: Narges PIRI, Bcs — Istanbul University-Cerrahpasa, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation
- Study coordinator: Narges PIRI Physiotherapist, BSc
- Email: nargespiri7@gmail.com
- Phone: 00905340672077
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.