Clinical trial NCT06744608: Effectiveness of Structured Myofascial Release
Official title: Effectiveness of Structured Myofascial Release in the Treatment of Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Myofascial Release
TENS (transcutaneous electrical nerve stimulation)
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Structured myofascial release group
2. Tens (transcutaneous electrical nerve stimulation) group
3. group that includes lifestyle changes
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: McGILL Pain Scale Short Form
timeFrame: three mounth
Secondary outcomes:
measure: Menstruation Symptom Scale
timeFrame: three mounth
measure: Functional and Emotional Dysmenorrhea Scale
timeFrame: three mounth
measure: Myotonometry (MyotonPRO)
timeFrame: three mounth
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Tepe Medical Center
state: Ümraniye
Study officials:
affiliation: İstanbul Medipol University
name: SERT BUSE
role: PRINCIPAL_INVESTIGATOR
References: