The Soft Tissue Mobilization Techniques on PMS

Premenstrual Syndrome Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05836454
• Other study ID #: PMSBloodFlow
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: June 2023
• Source: Eastern Mediterranean University
• Contact: Çisel Demiralp, Msc
• Phone: 05338412953
• Email: ptciseldemiralp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 94
• Est. completion date: September 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain
• Pelvic Pain
• Premenstrual Syndrome
• Syndrome

Intervention

Other:
• Progressive Muscle Relaxation Group:
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
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.

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Blood Flow Rate at Two Menstrual Cycle	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.	Baseline and 8 weeks
Primary	Follow- up Evaluation Blood Flow Rate	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.	8 weeks through study completion
Secondary	Change from Baseline Pain Severity at Two Menstrual Cycle	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.	Baseline and 8 weeks
Secondary	Follow-up Evaluation Pain Severity at Two Menstrual Cycle	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.	8 weeks through study completion
Secondary	Change from Baseline Pain Threshold at Two Menstrual Cycle	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.	Baseline and 8 weeks
Secondary	Follow-up Evaluation Pain Threshold	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.	8 weeks through study completion
Secondary	Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle	It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.	Baseline and 8 weeks
Secondary	Follow-up Evaluation Premenstrual Syndrome	It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.	8 weeks through study completion
Secondary	Change From Baseline Health-related Quality of Life at Two Menstrual Cycle	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.	Baseline and 8 weeks
Secondary	Follow-up Evaluation Health-related Quality of Life	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 weeks through study completion