Myofascial Release Technique in Women With Primary Dysmenorrhea

NCT06492148 | Recruiting

• 1 other identifier: 2023 - 1577
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

myofascial release; trigger point; Central sensitization; Dysmenorrhea; sham

Outcome Measures

Primary Outcomes (6)

• Pain Pressure Threshold

  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.

  Baseline (First menstruation cycle)

• Pain Pressure Threshold

  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.

  through study completion, an average of 3 months

• Central Sensitization

  Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.

  Baseline (First menstruation cycle)

• Central Sensitization

  Pain threshold will be measured with an algometer at a certain point of the tibialis muscle.

  through study completion, an average of 3 months

• Menstrual pain intensity

  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.

  Baseline (First menstruation cycle)

• Menstrual pain intensity

  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.

  through study completion, an average of 3 months

Secondary Outcomes (8)

• Menstrual Attitude

  Baseline (First menstruation cycle)

• Menstrual Attitude

  through study completion, an average of 3 months

• Health-related quality of life

  Baseline (First menstruation cycle)

• Health-related quality of life

  through study completion, an average of 3 months

• Anxiety

  Baseline (First menstruation cycle)

Study Arms (2)

Myofascial Release Group

ACTIVE COMPARATOR

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.

Other: Myofascial Release

Sham- Myofascial Release Group

SHAM COMPARATOR

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.

Other: Sham-Myofascial Release

Interventions

Myofascial Release 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.

Myofascial Release Group

Sham-Myofascial Release 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.

Sham- Myofascial Release Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, 06530, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes; Dysmenorrhea

Interventions

Myofascial Release Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Beyza Yazgan Dagli

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Research Asisstant

CONTACT

+905535134631; beyzayazgan@gazi.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: July 9, 2024
• Study Start: September 10, 2024
• Primary Completion: December 2, 2024
• Study Completion: September 25, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)