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The Soft Tissue Mobilization Techniques on PMS

Primary Purpose

Premenstrual Syndrome, Premenstrual Pain, Chronic Pelvic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Progressive Muscle Relaxation Group:
Myofascial Release Technique Group
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring myofascial releasing technique, progressive relaxation technique, blood flow velocity

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Mediterranean UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Progressive Muscle Relaxation Group:

Myofascial Release Technique Group

Control Group

Arm Description

Progressive Muscle Relaxation technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.

Myofascial Release Technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.

The control group will be asked to continue their normal lives.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Follow-up Evaluation Premenstrual Syndrome
It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.
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.
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.

Full Information

First Posted
March 14, 2023
Last Updated
June 9, 2023
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT05836454
Brief Title
The Soft Tissue Mobilization Techniques on PMS
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Premenstrual Pain, Chronic Pelvic Pain
Keywords
myofascial releasing technique, progressive relaxation technique, blood flow velocity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single Blind Randomized Controlled Study
Masking
Outcomes Assessor
Masking Description
Evaluations will be made by another physical therapist who is blinded to the groups.
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Progressive Muscle Relaxation Group:
Arm Type
Experimental
Arm Description
Progressive Muscle Relaxation technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.
Arm Title
Myofascial Release Technique Group
Arm Type
Experimental
Arm Description
Myofascial Release Technique will be applied to this group. Technique will be applied 3 days a week for 2 menstrual cycles.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group will be asked to continue their normal lives.
Intervention Type
Other
Intervention Name(s)
Progressive Muscle Relaxation Group:
Intervention Description
Progressive muscle relaxation is a relaxation technique that involves regular and sequential contraction and relaxation of muscles until the whole body is relaxed.
Intervention Type
Other
Intervention Name(s)
Myofascial Release Technique Group
Intervention Description
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 Outcome Measure Information:
Title
Change from Baseline Blood Flow Rate at Two Menstrual Cycle
Description
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.
Time Frame
Baseline and 8 weeks
Title
Follow- up Evaluation Blood Flow Rate
Description
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.
Time Frame
8 weeks through study completion
Secondary Outcome Measure Information:
Title
Change from Baseline Pain Severity at Two Menstrual Cycle
Description
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.
Time Frame
Baseline and 8 weeks
Title
Follow-up Evaluation Pain Severity at Two Menstrual Cycle
Description
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.
Time Frame
8 weeks through study completion
Title
Change from Baseline Pain Threshold at Two Menstrual Cycle
Description
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.
Time Frame
Baseline and 8 weeks
Title
Follow-up Evaluation Pain Threshold
Description
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.
Time Frame
8 weeks through study completion
Title
Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle
Description
It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.
Time Frame
Baseline and 8 weeks
Title
Follow-up Evaluation Premenstrual Syndrome
Description
It will be evaluated with the premenstrual symptom scale. Evaluates the symptoms related to premenstrual syndrome in detail.
Time Frame
8 weeks through study completion
Title
Change From Baseline Health-related Quality of Life at Two Menstrual Cycle
Description
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.
Time Frame
Baseline and 8 weeks
Title
Follow-up Evaluation Health-related Quality of Life
Description
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.
Time Frame
8 weeks through study completion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Çisel Demiralp, Msc
Phone
05338412953
Email
ptciseldemiralp@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Emine Handan Tüzün, Professor
Email
handan.tuzun@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çisel Demiralp, Msc
Organizational Affiliation
Eastern Meditteranean Univeristy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emine Handan Tüzün, Professor

12. IPD Sharing Statement

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The Soft Tissue Mobilization Techniques on PMS

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