Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
41 participants
INTERVENTIONAL
2023-07-27
2024-12-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The Weissman scale is scored between 0 and 3, where:
0: No dysmenorrhea
1. Minimal (Able to work but feels discomfort)
2. Moderate (Able to work but feels significant discomfort)
3. Severe (Unable to work, bedridden) According to the Weissman scale, women in groups 1 and 2 continue with their daily lives or work/school but experience significant declines in their quality of life. On the other hand, individuals in group 3 suffer from work loss. Primary dysmenorrhea is associated with a significant economic burden caused by absenteeism and 2 to 3 times higher healthcare costs. Considering this cycle repeats in every menstrual period, a treatment approach is needed not only to alleviate symptoms but also to address the pathophysiological mechanisms of dysmenorrhea. The aim is to reduce elevated prostaglandin levels, decrease increased uterine contractions, relieve ischemia, and improve blood flow using structured myofascial release techniques.
Structured Myofascial Release Techniques
Myofascial release techniques involve manual physiotherapy administered by a physiotherapist to eliminate myofascial trigger points, reduce muscle tension, and alleviate associated pain. Structured myofascial release techniques aim to:
Provide relaxation in smooth muscles and ligaments through direct techniques to reduce increased uterine contractions.
Achieve neural relaxation via sacral mobilization. Incorporate a dual relaxation protocol involving both mechanical correction and stimulation of the parasympathetic nervous system.
It is thought that applying these two methods together increases the likelihood of treatment success. In 2022, a study demonstrated that myofascial release provided more effective relaxation and symptom reduction compared to pelvic floor exercises in patients with primary dysmenorrhea. This project aims to evaluate the effectiveness of myofascial release techniques and investigate whether the treatment effect persists after the intervention.
TENS (transcutaneous electrical nerve stimulation)
In the TENS group, pain is reduced by direct application to the lower abdominal area through the gate control theory. TENS is hypothesized to have two effects:
Elevating the threshold of pain signals caused by uterine hypoxia and hypercontractility by sending afferent impulses via the large-diameter sensory fibers of the same nerve root, thereby reducing the perception of painful uterine signals.
Stimulating endorphin release from peripheral nerves and the spinal cord Research Question and Hypotheses Research Question: Can structured myofascial release techniques reduce pain and other symptoms in the treatment of primary dysmenorrhea?
H0: Myofascial release techniques have no effect on the symptoms of individuals with primary dysmenorrhea.
H1: Myofascial release techniques have an effect on the symptoms of individuals with primary dysmenorrhea.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
2. Tens (transcutaneous electrical nerve stimulation) group
3. group that includes lifestyle changes
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Structured Myofascial Release
The treatment program consisting of myofascial release techniques includes the following applications; 1. Anterolateral abdominal wall release (Until relaxation is felt); Along the fundus of the uterus, along the ovaries and the broad ligament of the uterus, combined mobilization with rotation of the uterus and hips in the supine position and sacral mobilization for three minutes. Myofascial release was started by placing the fingers/dorsal side of the hand on the fascia. Pressure was applied on the soft tissue. After the restricted layer was felt, the fascia was moved along the surface while in contact with the lower layers. The technique was applied for an average of 60-90 seconds, but if necessary, it was continued until relaxation was felt.
Structured Myofascial Release
haftada 2 seans 8 hafta boyunca toplam 16 seans uygulama yapıldı
TENS (transcutaneous electrical nerve stimulation)
The TENS (transcutaneous electrical nerve stimulation) treatment program was applied by a physiotherapist using two 50X50 mm electrodes on the lower abdomen using conventional TENS at 200 μs, 100 Hz, and 30 min.
.
tens (transcutaneous electrical nerve stimulation)
A total of 16 sessions of application were applied to the groups, 2 sessions per week for 8 weeks.
lifestyle changes
Within the scope of education including lifestyle changes; Good nutrition. (what to take and what to avoid), supplements, relaxation training, meditation, exercise recommendations, avoiding tobacco smoke, warm showers, quality sleep (at least 6-8 hours), wearing comfortable clothes are included in the recommendations.
lifestyle changes
A presentation including lifestyle changes was prepared and training was provided.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Structured Myofascial Release
haftada 2 seans 8 hafta boyunca toplam 16 seans uygulama yapıldı
tens (transcutaneous electrical nerve stimulation)
A total of 16 sessions of application were applied to the groups, 2 sessions per week for 8 weeks.
lifestyle changes
A presentation including lifestyle changes was prepared and training was provided.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Complaints of pain and spasm in the first 2 days of the menstrual cycle,
* Being two or above on the Weissmann scale,
* Being between the ages of 18-30,
* Volunteering to participate in the study
Exclusion Criteria
* Having a history of previous pregnancy,
* Using a medication that causes or affects dysmenorrhea,
* Being pregnant,
* Using intrauterine or oral contraceptives,
* Having a Body Mass Index (BMI) of 30 and above
18 Years
30 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medipol University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Buse Sert
MSc physiotherapist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
SERT BUSE
Role: PRINCIPAL_INVESTIGATOR
İstanbul Medipol University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tepe Medical Center
Istanbul, Ümraniye, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEDIPOLU-FTR-BS-01
Identifier Type: -
Identifier Source: org_study_id