Skip to main content
Clinical Trials/NCT06243562
NCT06243562
Not yet recruiting
Not Applicable

The Effects Of Progressive Muscle Relaxation Training in Addition to the Combined Exercise Training in Women With Fibromyalgia

Abant Izzet Baysal University1 site in 1 country42 target enrollmentStarted: February 15, 2024Last updated:
ConditionsFibromyalgia

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
42
Locations
1
Primary Endpoint
The Pain Catastrophizing Scale

Overview

Brief Summary

The purpose of the study is to examine the effects of progressive muscle relaxation training given in addition to a combined exercise program in women with fibromyalgia.

Detailed Description

Fibromyalgia syndrome is a complex, non-inflammatory pain syndrome characterized by whole-body pain, pain at specific tender points, fatigue, and sleep disturbance

The prevalence of fibromyalgia in the world population varies between 0.2% and 6.4%, and it more frequently affects middle-aged women (30-50 years old). the etiology of fibromyalgia is not fully known.

There are no generally accepted objective clinical findings, radiographic abnormalities, or laboratory tests to assess the presence of fibromyalgia and measure fibromyalgia severity. Therefore, questionnaires measuring patients' subjective responses remain important in the evaluation of fibromyalgia patients until now.

Current treatment recommendations for fibromyalgia strongly support a multifaceted regimen, including patient education, physical therapy, massage, cognitive behavioral therapy, specific pharmacotherapy, restorative sleep, and exercise. Exercise includes aerobic exercise, strengthening and stretching.

Progressive muscle relaxation therapy is an alternative complementary therapy based on the principle of progressive tensing and relaxing of major body muscles to relieve psychological tension. The therapy has no time or space restrictions and does not require any special equipment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Women diagnosed with fibromyalgia over the age of 20
  • volunteering to participate in the study.

Exclusion Criteria

  • neurological, infectious, endocrine and/or other inflammatory rheumatic diseases
  • serious psychiatric illness (schizophrenia, etc.)
  • any condition that prevents exercise (advanced heart, respiratory or orthopedic problems)
  • Malignancy
  • pregnancy
  • menopause
  • Participating in a physical therapy program (receiving exercise / relaxation training) in the last 6 months

Outcomes

Primary Outcomes

The Pain Catastrophizing Scale

Time Frame: Eight weeks

The Pain Catastrophizing Scale is a self-report measure of pain-related catastrophizing thinking. It consists of 13 items on a five-point Likert scale (0 = never to 4 = always ). The total score ranges from 0 to 52, with higher scores indicating higher levels of pain catastrophizing.

Visual Analog Scale

Time Frame: Eight weeks

The Visual Analog Scale measures pain intensity. It consists of a 10 cm line with two end points representing 0 (no pain) to 10 (pain as bad as possible). The patient marks the current pain level by placing a mark on the line.

Secondary Outcomes

  • COMPASS 31 Scale:(Eight weeks)
  • Blood Pressure(Eight weeks)
  • The Respiratory Frequency(Eight weeks)
  • Grip Strength(Eight weeks)
  • The Fibromyalgia Impact Scale(Eight weeks)
  • Skin Temperature(Eight weeks)
  • Pulse(Eight weeks)
  • Pittsburgh Sleep Quality Index(Eight weeks)
  • The Fatigue Severity Scale(Eight weeks)
  • Saturation(Eight weeks)
  • Sit and Reach Test(Eight weeks)
  • 6-Minute Walk Test(Eight weeks)
  • Perceived Stress Scale(eight weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eylem TÜTÜN YÜMİN

Professor

Abant Izzet Baysal University

Study Sites (1)

Loading locations...

Similar Trials