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CompletedNCT06744608Updated Dec 20, 2024

Effectiveness of Structured Myofascial Release

An interventional study of Structured Myofascial Release and tens (transcutaneous electrical nerve stimulation) in Primary Dysmenorrhea, sponsored by Medipol University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-20.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Jul 2023, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 30 Years
Sex
Female
01

Study summary

The aim of our research is to examine the effects of myofascial release techniques on symptoms in patients with primary dysmenorrhea. With this research, we aim to improve the clinical symptoms, pain and tension of primary dysmenorrhea with a structured manual therapy consisting of myofascial release and sacral mobilization in individuals with primary dysmenorrhea and an educational program that includes changes in daily life. Can Structured Myofascial Release Techniques Reduce Pain and Other Symptoms in Primary Dysmenorrhea? H0: Myofascial release techniques applied to individuals with primary dysmenorrhea have no effect on symptoms. H1: Myofascial release techniques applied to individuals with primary dysmenorrhea have an effect on symptoms.

Read the detailed description

Although primary dysmenorrhea is a common problem, especially among young women, there is generally no approach aimed at solving the main issue apart from symptomatic treatment or medication. Due to the side effects of medical treatments, many patients tend to opt for cheaper, non-medical, and non-aggressive methods.

The Weissman scale is scored between 0 and 3, where:

0: No dysmenorrhea

  1. Minimal (Able to work but feels discomfort)
  2. Moderate (Able to work but feels significant discomfort)
  3. Severe (Unable to work, bedridden) According to the Weissman scale, women in groups 1 and 2 continue with their daily lives or work/school but experience significant declines in their quality of life. On the other hand, individuals in group 3 suffer from work loss. Primary dysmenorrhea is associated with a significant economic burden caused by absenteeism and 2 to 3 times higher healthcare costs. Considering this cycle repeats in every menstrual period, a treatment approach is needed not only to alleviate symptoms but also to address the pathophysiological mechanisms of dysmenorrhea. The aim is to reduce elevated prostaglandin levels, decrease increased uterine contractions, relieve ischemia, and improve blood flow using structured myofascial release techniques.

Structured Myofascial Release Techniques

Myofascial release techniques involve manual physiotherapy administered by a physiotherapist to eliminate myofascial trigger points, reduce muscle tension, and alleviate associated pain. Structured myofascial release techniques aim to:

Provide relaxation in smooth muscles and ligaments through direct techniques to reduce increased uterine contractions.

Achieve neural relaxation via sacral mobilization. Incorporate a dual relaxation protocol involving both mechanical correction and stimulation of the parasympathetic nervous system.

It is thought that applying these two methods together increases the likelihood of treatment success. In 2022, a study demonstrated that myofascial release provided more effective relaxation and symptom reduction compared to pelvic floor exercises in patients with primary dysmenorrhea. This project aims to evaluate the effectiveness of myofascial release techniques and investigate whether the treatment effect persists after the intervention.

TENS (transcutaneous electrical nerve stimulation)

In the TENS group, pain is reduced by direct application to the lower abdominal area through the gate control theory. TENS is hypothesized to have two effects:

Elevating the threshold of pain signals caused by uterine hypoxia and hypercontractility by sending afferent impulses via the large-diameter sensory fibers of the same nerve root, thereby reducing the perception of painful uterine signals.

Stimulating endorphin release from peripheral nerves and the spinal cord Research Question and Hypotheses Research Question: Can structured myofascial release techniques reduce pain and other symptoms in the treatment of primary dysmenorrhea?

H0: Myofascial release techniques have no effect on the symptoms of individuals with primary dysmenorrhea.

H1: Myofascial release techniques have an effect on the symptoms of individuals with primary dysmenorrhea.

02

Conditions studied

  • Primary Dysmenorrhea

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Keywords

  • Myofascial Release
  • TENS (transcutaneous electrical nerve stimulation)
03

In context

Dysmenorrhea

398 studies on the registry are indexed under Dysmenorrhea; 96 are open to participants now.

This study's enrollment of 41 is below the median of 60 across 333 interventional studies indexed under Dysmenorrhea.

Browse Dysmenorrhea studies →

Lead sponsor

Medipol University is the lead sponsor of 311 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Primary dysmenorrhea diagnosed by a specialist gynecologist with 'Ultrasonography',
  • Complaints of pain and spasm in the first 2 days of the menstrual cycle,
  • Being two or above on the Weissmann scale,
  • Being between the ages of 18-30,
  • Volunteering to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Having pelvic pathology,
  • Having a history of previous pregnancy,
  • Using a medication that causes or affects dysmenorrhea,
  • Being pregnant,
  • Using intrauterine or oral contraceptives,
  • Having a Body Mass Index (BMI) of 30 and above
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • Active comparator
    Structured Myofascial Release

    The treatment program consisting of myofascial release techniques includes the following applications; 1. Anterolateral abdominal wall release (Until relaxation is felt); Along the fundus of the uterus, along the ovaries and the broad ligament of the uterus, combined mobilization with rotation of the uterus and hips in the supine position and sacral mobilization for three minutes. Myofascial release was started by placing the fingers/dorsal side of the hand on the fascia. Pressure was applied on the soft tissue. After the restricted layer was felt, the fascia was moved along the surface while in contact with the lower layers. The technique was applied for an average of 60-90 seconds, but if necessary, it was continued until relaxation was felt.

    Other: Structured Myofascial Release

  • Active comparator
    TENS (transcutaneous electrical nerve stimulation)

    The TENS (transcutaneous electrical nerve stimulation) treatment program was applied by a physiotherapist using two 50X50 mm electrodes on the lower abdomen using conventional TENS at 200 μs, 100 Hz, and 30 min. .

    Device: tens (transcutaneous electrical nerve stimulation)

  • Active comparator
    lifestyle changes

    Within the scope of education including lifestyle changes; Good nutrition. (what to take and what to avoid), supplements, relaxation training, meditation, exercise recommendations, avoiding tobacco smoke, warm showers, quality sleep (at least 6-8 hours), wearing comfortable clothes are included in the recommendations.

    Behavioral: lifestyle changes

Interventions

  • OtherStructured Myofascial Release

    haftada 2 seans 8 hafta boyunca toplam 16 seans uygulama yapıldı

  • Devicetens (transcutaneous electrical nerve stimulation)

    A total of 16 sessions of application were applied to the groups, 2 sessions per week for 8 weeks.

  • Behaviorallifestyle changes

    A presentation including lifestyle changes was prepared and training was provided.

06

What researchers measure

Primary outcomes

  1. McGILL Pain Scale Short Form

    The McGill pain questionnaire consists of four sections. In the first section, the individual marks the location of the pain on the body diagram and determines whether the pain comes from deep or superficial. In the second section, there are 20 word groups that examine pain in terms of sensory, perceptual and evaluative aspects. The individual is asked to select a set of words that fit their pain and mark the word that fits their pain within the selected set. The third section includes the relationship between pain and time. In the fourth section, five word groups ranging from "mild" pain to "unbearable" pain are defined to determine the severity of pain. The McGill Pain Questionnaire determines the location of the pain, the feeling it creates in the individual, its relationship with time, its severity and the level of pain that can be experienced by the individual. A high score indicates high level pain.

    Time frame: three mounth

Secondary outcomes

  1. Menstruation Symptom Scale

    Menstrual Symptom Questionnaire (MSQ): The MSQ is a five-point Likert-type scale consisting of twenty-two items. Participants are asked to rate the symptoms they experience related to menstruation between 1 (never) and 5 (always). The scale has three sub-dimensions: 'Negative Effects/Somatic Complaints' (Items 1-13), 'Menstrual Pain Symptoms' (Items 14-19) and 'Coping Methods' (Items 20-22). The highest score that can be obtained from the scale is 110, and the lowest score is 22. The MSQ score is calculated by taking the total score average of the items in the scale. An increase in the score average indicates an increase in the severity of menstrual symptoms.

    Time frame: three mounth

  2. Functional and Emotional Dysmenorrhea Scale

    This is a 14-item Likert-type scale used to measure dysmenorrhea functionally and emotionally. The options on the scale are: (1) It is not like my situation at all, (2) It is not like my situation at all, (3) It is both similar and not like my situation, (4) It is considered similar to my situation, (5) It is very similar to my situation. There are no reverse items in the scale items. The scale was developed to provide functional and emotional measurement of dysmenorrhea. As the scores obtained from the scale increase, the functional and emotional effects of dysmenorrhea also increase.

    Time frame: three mounth

  3. Myotonometry (MyotonPRO)

    Myotonometry is an objective measurement method for measuring the physiological properties of muscle tone, including stiffness. MyotonPRO is a small, non-invasive, handheld myotonometer that provides an objective measurement of the mechanical properties of muscles in vivo. This measurement is a non-invasive approach, where the response of the muscle is recorded using small mechanical stimuli given by the device. In our case, the measurement will be performed in the lower abdomen, at the level of the uterine fundus.

    Time frame: three mounth

07

Study locations

1 site
  • Tepe Medical Center
    Istanbul, Ümraniye 34771, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06744608
Lead sponsor
Medipol University
Responsible party
Buse Sert (MSc physiotherapist, Medipol University) — Principal investigator
First posted
Dec 20, 2024
Start date
Jul 27, 2023
Primary completion
Dec 1, 2024
Completion
Dec 16, 2024
Last update
Dec 20, 2024

Study contacts

SERT BUSE
principal investigator · İstanbul Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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