Effectiveness of Structured Myofascial Release

Medipol University

Status: Completed

Conditions: Primary Dysmenorrhea

Treatments: Other: Structured Myofascial Release; Behavioral: lifestyle changes; Device: tens (transcutaneous electrical nerve stimulation)

Study type: Interventional

Funder types: Other

Identifiers

NCT06744608

MEDIPOLU-FTR-BS-01

Details and patient eligibility

About

The aim of our research is to examine the effects of myofascial release techniques on symptoms in patients with primary dysmenorrhea. With this research, we aim to improve the clinical symptoms, pain and tension of primary dysmenorrhea with a structured manual therapy consisting of myofascial release and sacral mobilization in individuals with primary dysmenorrhea and an educational program that includes changes in daily life. Can Structured Myofascial Release Techniques Reduce Pain and Other Symptoms in Primary Dysmenorrhea? H0: Myofascial release techniques applied to individuals with primary dysmenorrhea have no effect on symptoms. H1: Myofascial release techniques applied to individuals with primary dysmenorrhea have an effect on symptoms.

Full description

Although primary dysmenorrhea is a common problem, especially among young women, there is generally no approach aimed at solving the main issue apart from symptomatic treatment or medication. Due to the side effects of medical treatments, many patients tend to opt for cheaper, non-medical, and non-aggressive methods.

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.

Enrollment: 41 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Primary dysmenorrhea diagnosed by a specialist gynecologist with 'Ultrasonography',
• 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 pelvic pathology,
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

Structured Myofascial Release

Active Comparator group

Description:

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.

Treatment:

Other: Structured Myofascial Release

TENS (transcutaneous electrical nerve stimulation)

Active Comparator group

Description:

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. .

Treatment:

Device: tens (transcutaneous electrical nerve stimulation)

lifestyle changes

Active Comparator group

Description:

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.

Treatment:

Behavioral: lifestyle changes