Myofascial Release Technique in Women With Primary Dysmenorrhea

Not Applicable

Recruiting

• Conditions: Myofascial Trigger Point Pain; Central Sensitisation; Dysmenorrhea Primary; Myofascial Release; Menstrual Discomfort

• Registration Number: NCT06492148
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-09-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2024-12-02
• Study Completion: 2025-09-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Central Sensitization	through study completion, an average of 3 months	Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.
Pain Pressure Threshold	through study completion, an average of 3 months	Trigger points in specific muscles (rectus abdominis, paraspinal muscles, quadratus lumborum, gluteus maximus) will be determined. Then, it will be applied to the trigger points with the Baseline brand algometer in accordance with standard procedures and the pressure will be increased by 30 kPa/s.
Menstrual pain intensity	through study completion, an average of 3 months	Menstrual pain intensity will be determined by a 10 cm Visual Analog Scale ranging from zero (no pain at all) to 10 (worst pain I have ever felt). Higher scores mean worse conditions. Participants will be asked to mark the severity of pain they felt in the first 3 days of their last menstrual bleeding on 3 separate lines.

Secondary Outcome Measures

Name	Time	Method
Anxiety	through study completion, an average of 3 months	State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.
The Body Awareness	through study completion, an average of 3 months	The Body Awareness Questionnaire will be used to evaluate changes in individuals' body awareness. The questionnaire consists of 18 items and 4 subscales (predicting body reactions, sleep-wake cycle, predicting the onset of the disease, paying attention to changes in body processes).
Menstrual Attitude	through study completion, an average of 3 months	Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.
Health-related quality of life	through study completion, an average of 3 months	SF-36 will be used to evaluate individuals' general health-related quality of life. SF-36 is a 36-question survey that evaluates functionality and well-being and consists of 8 subscales. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Higher scores indicate a better quality of life.

Trial Locations

Locations (1)

Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University; 🇹🇷 Ankara, Turkey