Clinical trial NCT06492148: Myofascial Release Technique in Women With Primary Dysmenorrhea
Official title: Effect of Myofascial Release Technique on Central Sensitization, Myofascial Trigger Point and Menstrual Symptoms in Women With Primary Dysmenorrhea: Sham-Controlled, Randomized Double-Blind Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dysmenorrhea Primary
Central Sensitisation
Myofascial Trigger Point Pain
Menstrual Discomfort
Myofascial Release
Keywords: myofascial release
trigger point
Central sensitization
Dysmenorrhea
sham
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It has been found that women with dysmenorrhea have active trigger points, particularly in the rectus abdominis, oblique abdominal muscles, quadratus lumborum, and paraspinal muscles. The myofascial release technique is a widely used manual therapy method characterized by the application of low-load, long-duration mechanical forces to manipulate the myofascial complex. This technique aims to restore optimal length, alleviate pain, and improve function. This study aims to examine the effect of the myofascial release technique on central sensitization, myofascial trigger points, and menstrual symptoms in women with primary dysmenorrhea.

Detailed description: During the evaluation period, the participants' musculoskeletal pain threshold and tolerance will be measured using an algometer, about trigger points on the identified muscles (rectus abdominis, quadratus lumborum, erector spinae, and tibialis anterior). A total of 40 women, aged 18-40, diagnosed with primary dysmenorrhea by a gynecologist, will be included in the study. The initial assessment of the participants will be conducted on their most painful days. Participants will be randomized into two groups: the myofascial release technique group (study group) and the placebo myofascial release technique group (control group). The interventions will be conducted over 10 sessions during one menstrual cycle, and all evaluations will be repeated after the treatment period. The study will be conducted as a double-blind trial, ensuring that both the evaluators and the patients are blind to the group assignments.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide,
* Having regular menstruation in the last 6 months (28±7 days)
* Those who had menstrual pain between 40 mm and 100 mm according to the Visual Analogue Scale (VAS) in the last 6 months

Exclusion Criteria:

* Diagnosed with Secondary Dysmenorrhea,
* Having given birth,
* Those with serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes,
* Undergoing urogynecological surgery,
* Those who are pregnant or suspected of pregnancy,
* Those who use analgesics or non-pharmacological agents other than NSAIDs for menstrual pain,
* Those using intrauterine or oral contraceptives,
* Those taking extra supplements such as magnesium, which may affect treatment

Primary outcomes:
measure: Pain Pressure Threshold
timeFrame: Baseline (First menstruation cycle)
measure: Pain Pressure Threshold
timeFrame: through study completion, an average of 3 months
measure: Central Sensitization
timeFrame: Baseline (First menstruation cycle)
measure: Central Sensitization
timeFrame: through study completion, an average of 3 months
measure: Menstrual pain intensity
timeFrame: Baseline (First menstruation cycle)
measure: Menstrual pain intensity
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
measure: Menstrual Attitude
timeFrame: Baseline (First menstruation cycle)
measure: Menstrual Attitude
timeFrame: through study completion, an average of 3 months
measure: Health-related quality of life
timeFrame: Baseline (First menstruation cycle)
measure: Health-related quality of life
timeFrame: through study completion, an average of 3 months
measure: Anxiety
timeFrame: Baseline (First menstruation cycle)
measure: Anxiety
timeFrame: through study completion, an average of 3 months
measure: The Body Awareness
timeFrame: Baseline (First menstruation cycle)
measure: The Body Awareness
timeFrame: through study completion, an average of 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University
Study officials:
affiliation: Gazi University
name: Beyza Yazgan Dagli
role: PRINCIPAL_INVESTIGATOR
References: