Clinical trial NCT06243562: The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia
Official title: The Effects Of Progressive Muscle Relaxation Training in Addition to the Combined Exercise Training in Women With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: fibromyalgia
progressive muscle relaxation
combined exercise
rehabilitation
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be an intervention and control group in the study.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Eight weeks
measure: The Pain Catastrophizing Scale
timeFrame: Eight weeks
Secondary outcomes:
measure: The Fibromyalgia Impact Scale
timeFrame: Eight weeks
measure: COMPASS 31 Scale:
timeFrame: Eight weeks
measure: Skin Temperature
timeFrame: Eight weeks
measure: Pulse
timeFrame: Eight weeks
measure: Saturation
timeFrame: Eight weeks
measure: Blood Pressure
timeFrame: Eight weeks
measure: The Respiratory Frequency
timeFrame: Eight weeks
measure: Sit and Reach Test
timeFrame: Eight weeks
measure: Grip Strength
timeFrame: Eight weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: Eight weeks
measure: 6-Minute Walk Test
timeFrame: Eight weeks
measure: Perceived Stress Scale
timeFrame: eight weeks
measure: The Fatigue Severity Scale
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Bolu Abant İzzet Baysal University
name: Eylem TÜTÜN YÜMİN, Professor
role: STUDY_DIRECTOR
References: