Myofascial Release Technique in Women With Primary Dysmenorrhea

NCT ID: NCT06492148

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-09-25

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Myofascial Release Group

The technique known as myofascial release, also referred to as cross-hand release, will be applied to 7 regions. Among these regions are the lateral abdominal wall (right and left), the lower abdomen with the opposite side medial thigh (right and left crossed), the thoracolumbar fascia (bilateral), and the lumbosacral region. In the cross-hand technique, hands will be gently placed on the specified regions and directions. The release of the barriers of the tissue under the hands will be ensured, and the technique will be applied until a wave or oscillation is felt. A myofascial release technique with an optimal duration of 5 minutes will be applied to each region. The total treatment time will be 35 minutes.

Group Type: ACTIVE_COMPARATOR

Myofascial Release

Intervention Type: OTHER

The myofascial release technique is a widely used manual therapy method characterized by low-load, prolonged mechanical forces applied to manipulate the myofascial complex, aiming to restore optimal length, alleviate pain, and improve function.

Sham- Myofascial Release Group

The hands of the researcher applying the technique will be positioned on the same regions as the myofascial release technique, with only the palms lightly touching for the same duration. However, there will be no intervention aimed at applying pressure or opening tissue barriers. The total sham treatment time will be 35 minutes.

Group Type: SHAM_COMPARATOR

Sham-Myofascial Release

Intervention Type: OTHER

The hands of the researcher applying the technique will be placed in the same areas as the myofascial release technique, with only the palms in light contact for the same duration. However, no intervention will be made to create any pressure or open the tissue barrier.

Interventions

Myofascial Release

The myofascial release technique is a widely used manual therapy method characterized by low-load, prolonged mechanical forces applied to manipulate the myofascial complex, aiming to restore optimal length, alleviate pain, and improve function.

Intervention Type: OTHER

Sham-Myofascial Release

The hands of the researcher applying the technique will be placed in the same areas as the myofascial release technique, with only the palms in light contact for the same duration. However, no intervention will be made to create any pressure or open the tissue barrier.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

BEYZA YAZGAN DAĞLI

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beyza Yazgan Dagli

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Research Asisstant

Role: CONTACT

beyzayazgan@gazi.edu.tr

+905535134631

Facility Contacts

Beyza Yazgan Dagli

Role: primary

beyzayazgan@gazi.edu.tr

Other Identifiers

2023 - 1577

Identifier Type: -

Identifier Source: org_study_id