MedPath

The Soft Tissue Mobilization Techniques on PMS

Not Applicable
Recruiting
Conditions
Premenstrual Syndrome
Premenstrual Pain
Chronic Pelvic Pain
Interventions
Other: Myofascial Release Technique Group
Registration Number
NCT05836454
Lead Sponsor
Eastern Mediterranean University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
94
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Myofascial Release Technique GroupMyofascial Release Technique GroupMyofascial Release Technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.
Primary Outcome Measures
NameTimeMethod
Change from Baseline Blood Flow Rate at Two Menstrual CycleBaseline 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.

Follow- up Evaluation Blood Flow Rate8 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 Outcome Measures
NameTimeMethod
Follow-up Evaluation Pain Severity at Two Menstrual Cycle8 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.

Follow-up Evaluation Health-related Quality of Life8 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.

Follow-up Evaluation Pain Threshold8 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.

Change from Baseline Premenstrual Syndrome at Two Menstrual CycleBaseline and 8 weeks

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

Follow-up Evaluation Premenstrual Syndrome8 weeks through study completion

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

Change from Baseline Pain Threshold at Two Menstrual CycleBaseline 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.

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

Change from Baseline Pain Severity at Two Menstrual CycleBaseline 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.

Trial Locations

Locations (1)

Eastern Mediterranean University

🇨🇾

Famagusta, Cyprus

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