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Recruiting NCT06492148

Myofascial Release Technique in Women With Primary Dysmenorrhea

No phase Interventional Dysmenorrhea Primary Central Sensitisation Myofascial Trigger Point Pain Menstrual Discomfort

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myofascial Release, Sham-Myofascial Release.
Who it may be relevant to
Registry conditions: Dysmenorrhea Primary, Central Sensitisation, Myofascial Trigger Point Pain, Menstrual Discomfort. Basic parameters: 18 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Pain Pressure Threshold [Time frame: Baseline (First menstruation cycle)]
  • Pain Pressure Threshold [Time frame: through study completion, an average of 3 months]
  • Central Sensitization [Time frame: Baseline (First menstruation cycle)]
  • Central Sensitization [Time frame: through study completion, an average of 3 months]
  • Menstrual pain intensity [Time frame: Baseline (First menstruation cycle)]
  • Menstrual pain intensity [Time frame: through study completion, an average of 3 months]
Secondary outcome measures (8)
  • Menstrual Attitude [Time frame: Baseline (First menstruation cycle)]
  • Menstrual Attitude [Time frame: through study completion, an average of 3 months]
  • Health-related quality of life [Time frame: Baseline (First menstruation cycle)]
  • Health-related quality of life [Time frame: through study completion, an average of 3 months]
  • Anxiety [Time frame: Baseline (First menstruation cycle)]
  • Anxiety [Time frame: through study completion, an average of 3 months]
  • The Body Awareness [Time frame: Baseline (First menstruation cycle)]
  • The Body Awareness [Time frame: through study completion, an average of 3 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences, Gazi Universit — Ankara

Identifiers

NCT: NCT06492148 · 2023 - 1577

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗