Clinical trial NCT05836454: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Premenstrual Syndrome
Premenstrual Pain
Chronic Pelvic Pain
Keywords: myofascial releasing technique
progressive relaxation technique
blood flow velocity
Lead sponsor: Eastern Mediterranean University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind Randomized Controlled Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline Blood Flow Rate at Two Menstrual Cycle
timeFrame: Baseline and 8 weeks
measure: Follow- up Evaluation Blood Flow Rate
timeFrame: 8 weeks through study completion
Secondary outcomes:
measure: Change from Baseline Pain Severity at Two Menstrual Cycle
timeFrame: Baseline and 8 weeks
measure: Follow-up Evaluation Pain Severity at Two Menstrual Cycle
timeFrame: 8 weeks through study completion
measure: Change from Baseline Pain Threshold at Two Menstrual Cycle
timeFrame: Baseline and 8 weeks
measure: Follow-up Evaluation Pain Threshold
timeFrame: 8 weeks through study completion
measure: Change from Baseline Premenstrual Syndrome at Two Menstrual Cycle
timeFrame: Baseline and 8 weeks
measure: Follow-up Evaluation Premenstrual Syndrome
timeFrame: 8 weeks through study completion
measure: Change From Baseline Health-related Quality of Life at Two Menstrual Cycle
timeFrame: Baseline and 8 weeks
measure: Follow-up Evaluation Health-related Quality of Life
timeFrame: 8 weeks through study completion
Other outcomes:
Locations:
city: Famagusta
country: Cyprus
facility: Eastern Mediterranean University
Study officials:
affiliation: Eastern Meditteranean Univeristy
name: Çisel Demiralp, Msc
role: PRINCIPAL_INVESTIGATOR
References: