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Completed

NCT Number: NCT05836454

The Soft Tissue Mobilization Techniques on PMS

The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment and post- treatment assessment will be done. Follow-up evaluation will be done on the fifth cycle, two cycles after the post-treatment evaluation.

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Key information

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Eastern Mediterranean University

Famagusta, Cyprus

About this study

The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. The study planned as a single-blind randomized controlled trial. The volunteers who were invited to the study and signed the voluntary consent form will be randomized via random allocation software to divided into 3 groups. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment will be done in the first 3 days of the first cycle, after first treatment acute assessment will be done. Post-treatment evaluation will be done in the first 3 days of the 3rd cycle after treatment for two cycles. Follow-up evaluation will be done in the first 3 days of the fifth cycle, two cycles after the post-treatment evaluation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain score of 4 cm or more according to the Visual Analogue Scale.
  • Having a regular menstrual cycle for 12 months (24-35 days).
  • According to the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the weekly Metabolic Equivalent of Task (MET) value is below 600 MET-min/week.

Exclusion criteria

  • Those who have undergone surgery in the last 6 months,
  • Those who use cigarettes and alcohol,
  • Those who are pregnant,
  • Those with urinary, genital, gastrointestinal disorders,
  • Those who have had hysterectomy surgery will be excluded.

Treatment and study plan

Progressive Muscle Relaxation Group:

Other

Progressive muscle relaxation is a relaxation technique that involves regular and sequential contraction and relaxation of muscles until the whole body is relaxed.

Myofascial Release Technique Group

Other

It is a physiotherapy technique based on soft tissue mobilization. All enveloping fascia sale prices are positive for mobility, a user used for adhesions and pain.

Primary outcomes

  1. Change from Baseline Blood Flow Rate at Two Menstrual Cycle

    Time frame: Baseline and 8 weeks

    Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.

  2. Follow- up Evaluation Blood Flow Rate

    Time frame: 8 weeks through study completion

    Blood flow rate will be evaluated with the portable vascular doppler. Measurements will be made from the right or left common iliac artery, branches of the abdominal aorta, and the ipsilateral femoral artery. After the ultrasound gel is applied to the measurement area, the probe will be placed at an angle of 30° and the measurement will be taken.

Secondary outcomes

  1. Change from Baseline Pain Severity at Two Menstrual Cycle

    Time frame: Baseline and 8 weeks

    It will be evaluated with the visual analog scale. Pain is determined by measuring the mark on the 10-centimeter line according to the severity of the pain. According to the Visual Analogue Scale (VAS), a score of 0 indicates no pain, and 10 indicates unbearable pain.

  2. Follow-up Evaluation Pain Severity at Two Menstrual Cycle

    Time frame: 8 weeks through study completion

    It will be evaluated with the visual analog scale. Pain is determined by measuring the mark on the 10-centimeter line according to the severity of the pain. According to the VAS, a score of 0 indicates no pain, and 10 indicates unbearable pain.

  3. Change from Baseline Pain Threshold at Two Menstrual Cycle

    Time frame: Baseline and 8 weeks

    It will be evaluated with a digital algometer and the value on the algometer will be recorded in kg. Evaluation areas are Vastus medialis, Pectoralis major, Gluteus maximus, Gluteus medius, Iliopsoas, Lumbal paraspinal, Trapezius, Spina iliaca anterior superior (SIAS). Measurements will be made from the muscle body.

  4. Follow-up Evaluation Pain Threshold

    Time frame: 8 weeks through study completion

    It will be evaluated with a digital algometer and the value on the algometer will be recorded in kg. Evaluation areas are Vastus medialis, Pectoralis major, Gluteus maximus, Gluteus medius, Iliopsoas, Lumbal paraspinal, Trapezius, Spina iliaca anterior superior (SIAS). Measurements will be made from the muscle body.

  5. Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle

    Time frame: Baseline and 8 weeks

    It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.

  6. Follow-up Evaluation Premenstrual Syndrome

    Time frame: 8 weeks through study completion

    It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.

  7. Change From Baseline Health-related Quality of Life at Two Menstrual Cycle

    Time frame: Baseline and 8 weeks

    It will be evaluated with the SF-36 short form. Turkish validity and reliability study made by Kocyigit et al. In the evaluation of the scale, a score between 0-100 points can obtained from each sub-dimension, 0 points indicates that the quality of life dimension is bad and 100 points that it is good.

  8. Follow-up Evaluation Health-related Quality of Life

    Time frame: 8 weeks through study completion

    It will be evaluated with the SF-36 short form. Turkish validity and reliability study made by Kocyigit et al. In the evaluation of the scale, a score between 0-100 points can obtained from each sub-dimension, 0 points indicates that the quality of life dimension is bad and 100 points that it is good.

Sponsors and collaborators

Lead sponsor

Eastern Mediterranean University

Other

Registry information

Official study title

The Effect of Progressive Muscle Relaxation Technique and Myofascial Release Technique on Premenstrual Symptoms, Blood Circulation, and Quality of Life in Women With Premenstrual Syndrome: a Single-blind Randomized Controlled Study

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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