Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
ID06492148

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

Led by Gazi University · Updated on 2024-11-21

36

Participants Needed

1

Research Sites

42 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying women aged 18 to 40 with primary dysmenorrhea, a condition causing painful menstrual cramps. The study aims to evaluate how the myofascial release technique affects central sensitization, myofascial trigger points, and menstrual symptoms. This manual therapy method applies gentle, prolonged pressure to muscle and connective tissue to improve pain and function. The goal is to understand its impact on pain sensitivity and menstrual discomfort in affected women. Participants will be randomly assigned to one of two groups: one receiving the active myofascial release technique and the other receiving a sham treatment with light touch but no pressure. The active treatment involves applying the technique to seven specific body regions for about 35 minutes per session, over 10 sessions during a menstrual cycle. The sham group will have the same hand placements and duration, but without therapeutic pressure or tissue release. During the study, researchers will assess participants' pain pressure thresholds, central sensitization levels, and menstrual pain intensity before and after treatment. Secondary measures include menstrual attitudes, quality of life, anxiety, and body awareness. Evaluations will occur on the most painful days and continue through an average follow-up of three months. The trial uses a double-blind design to keep both patients and evaluators unaware of group assignments, ensuring unbiased results.

CONDITIONS

Brief Title

Myofascial Release Technique in Women With Primary Dysmenorrhea

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Primary Dysmenorrhea according to the Primary Dysmenorrhea Consensus Guide
  • Having regular menstruation in the last 6 months (28�B17 days)
  • Experiencing menstrual pain between 40 mm and 100 mm on the Visual Analogue Scale (VAS) in the last 6 months
  • Female aged between 18 and 35 years
Not Eligible

You will not qualify if you...

  • Diagnosed with Secondary Dysmenorrhea
  • Having given birth
  • Having serious gastrointestinal, urogynecological, or autoimmune diseases or other chronic pain syndromes
  • Undergoing urogynecological surgery
  • Pregnant or suspected of being pregnant
  • Using analgesics or non-pharmacological agents other than NSAIDs for menstrual pain
  • Using intrauterine or oral contraceptives
  • Taking extra supplements such as magnesium that may affect treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - One menstrual cycle

Participants receive either the myofascial release technique or a sham version over 10 sessions during one menstrual cycle.

10 visits (in-person)

Follow-up

Duration - Approximately 3 months

Participants undergo evaluations of pain, central sensitization, and menstrual symptoms after the treatment period over approximately 3 months.

Follow-up assessments after treatment completion

Trial Site Locations

Total: 1 location

1

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

Ankara, Turkey (Türkiye), 06530

Actively Recruiting

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Research Team

R

Research Asisstant

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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