Myofascial Release Technique in Women With Primary Dysmenorrhea

Effect of Myofascial Release Technique on Central Sensitization, Myofascial Trigger Point and Menstrual Symptoms in Women With Primary Dysmenorrhea: Sham-Controlled, Randomized Double-Blind Study

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.

Study Overview

• Status: Recruiting
• Conditions: Myofascial Trigger Point Pain; Central Sensitisation; Menstrual Discomfort; Dysmenorrhea Primary; Myofascial Release
• Intervention / Treatment: Other: Myofascial Release; Other: Sham-Myofascial Release

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.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Research Asisstant; Phone Number: +905535134631; Email: beyzayazgan@gazi.edu.tr

Study Locations

• Turkey
  • Ankara, Turkey, 06530
    • Recruiting
    • Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi University
    • Contact: Beyza Yazgan Dagli; Email: beyzayazgan@gazi.edu.tr
    • Principal Investigator: Beyza Yazgan Dagli
    • Principal Investigator: Sevim B Olmez
    • Principal Investigator: Zeynep B Alkan
    • Principal Investigator: Zeynep Hazar Kanık

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: 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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual Attitude	Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.	Baseline (First menstruation cycle)
Menstrual Attitude	Menstrual Attitude Scale will be used to evaluate symptoms related to menstruation. High scores indicate a high awareness of menstruation.	through study completion, an average of 3 months
Health-related quality of life	Short Form (SF-36) will be used to evaluate individuals' general health-related quality of life. SF-36 is a 36-question survey that evaluates functionality and well-being and consists of 8 subscales. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Higher scores indicate a better quality of life.	Baseline (First menstruation cycle)
Health-related quality of life	SF-36 will be used to evaluate individuals' general health-related quality of life. SF-36 is a 36-question survey that evaluates functionality and well-being and consists of 8 subscales. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Higher scores indicate a better quality of life.	through study completion, an average of 3 months
Anxiety	State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.	Baseline (First menstruation cycle)
Anxiety	State and Trait Anxiety Scale is a self-assessment inventory that evaluates anxiety and consists of 40 items.	through study completion, an average of 3 months
The Body Awareness	The Body Awareness Questionnaire will be used to evaluate changes in individuals' body awareness. The questionnaire consists of 18 items and 4 subscales (predicting body reactions, sleep-wake cycle, predicting the onset of the disease, paying attention to changes in body processes).	Baseline (First menstruation cycle)
The Body Awareness	The Body Awareness Questionnaire will be used to evaluate changes in individuals' body awareness. The questionnaire consists of 18 items and 4 subscales (predicting body reactions, sleep-wake cycle, predicting the onset of the disease, paying attention to changes in body processes).	through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Principal Investigator: Beyza Yazgan Dagli, Gazi University

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): December 2, 2024
• Study Completion (Estimated): September 25, 2025

Study Registration Dates

• First Submitted: June 11, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Dysmenorrhea; trigger point; Central sensitization; myofascial release; sham
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Myofascial Pain Syndromes; Dysmenorrhea
• Other Study ID Numbers: 2023 - 1577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No