Effectiveness of Structured Myofascial Release

NCT06744608 | Completed

• 1 other identifier: MEDIPOLU-FTR-BS-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Dysmenorrhea

Keywords

Myofascial Release; TENS (transcutaneous electrical nerve stimulation)

Outcome Measures

Primary Outcomes (1)

• McGILL Pain Scale Short Form

  The McGill pain questionnaire consists of four sections. In the first section, the individual marks the location of the pain on the body diagram and determines whether the pain comes from deep or superficial. In the second section, there are 20 word groups that examine pain in terms of sensory, perceptual and evaluative aspects. The individual is asked to select a set of words that fit their pain and mark the word that fits their pain within the selected set. The third section includes the relationship between pain and time. In the fourth section, five word groups ranging from "mild" pain to "unbearable" pain are defined to determine the severity of pain. The McGill Pain Questionnaire determines the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of pain that can be experienced by the individual. A high score indicates high level pain.

  three mounth

Secondary Outcomes (3)

• Menstruation Symptom Scale

  three mounth

• Functional and Emotional Dysmenorrhea Scale

  three mounth

• Myotonometry (MyotonPRO)

  three mounth

Study Arms (3)

Structured Myofascial Release

ACTIVE COMPARATOR

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.

Other: Structured Myofascial Release

TENS (transcutaneous electrical nerve stimulation)

ACTIVE COMPARATOR

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. .

Device: tens (transcutaneous electrical nerve stimulation)

lifestyle changes

ACTIVE COMPARATOR

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.

Behavioral: lifestyle changes

Interventions

Structured Myofascial Release OTHER

haftada 2 seans 8 hafta boyunca toplam 16 seans uygulama yapıldı

Structured Myofascial Release

tens (transcutaneous electrical nerve stimulation) DEVICE

A total of 16 sessions of application were applied to the groups, 2 sessions per week for 8 weeks.

TENS (transcutaneous electrical nerve stimulation)

lifestyle changes BEHAVIORAL

A presentation including lifestyle changes was prepared and training was provided.

lifestyle changes

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Tepe Medical Center

Istanbul, Ümraniye, 34771, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• SERT BUSE

  İstanbul Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc physiotherapist

Model Details: 1. Structured myofascial release group 2. Tens (transcutaneous electrical nerve stimulation) group 3. group that includes lifestyle changes

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: July 27, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 16, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)