The Effects Of Progressive Muscle Relaxation Training in Women With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06243562
• Other study ID #: AIBU-FTR-ETY-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: February 15, 2025

Study information

• Verified date: February 2024
• Source: Abant Izzet Baysal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: February 15, 2025
• Est. primary completion date: April 12, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• combined exercises and progressive muscle relaxation group
Participants in the intervention group will receive a combined exercise program that will last 45-60 minutes, 3 days a week for 8 weeks, and progressive muscle relaxation training that will last 10-15 minutes, under the supervision of a therapist.
• combined exercises group
Patients in the control group will perform a combined exercise consisting of aerobic, strengthening and stretching exercises, which will last 45-60 minutes, 3 days a week for 8 weeks, under the supervision of a physiotherapist. At the end of the combined exercise program, they will rest in the relaxation position for 10-15 minutes each session.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale	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.	Eight weeks
Primary	The Pain Catastrophizing Scale	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.	Eight weeks
Secondary	The Fibromyalgia Impact Scale	The Fibromyalgia Impact Scale assesses the severity of fibromyalgia and its impact on daily function. It contains 10 items: subscores are summed to create a scale from 0 to 100, with a higher score indicating worse symptoms and greater dysfunction.	Eight weeks
Secondary	COMPASS 31 Scale:	COMPASS 31 scale is a self-assessment tool that investigates autonomic symptoms. The scale contains 31 items assessing six domains of autonomic functions. The total score ranges from 0 (normal) to 100 (worst case).	Eight weeks
Secondary	Skin Temperature	Peripheral skin temperature will be measured from the medial longitudinal arch with a thermometer.; Local skin temperature will be measured with a thermometer from : Right and left lower costal margins, the highest point of the iliac crest (superior side) and the posterior superior iliac spine (inferior side).	Eight weeks
Secondary	Pulse	Pulse will be measured with a pulse oximeter attached to the fingertip.	Eight weeks
Secondary	Saturation	Saturation will be measured with a pulse oximeter attached to the fingertip.	Eight weeks
Secondary	Blood Pressure	The patients' blood pressure will be measured with a sphygmomanometer	Eight weeks
Secondary	The Respiratory Frequency	The respiratory frequency value will be obtained by multiplying the number of breaths in and out for thirty seconds by two.	Eight weeks
Secondary	Sit and Reach Test	Flexibility will be evaluated with the sit and reach test. Subjects will be asked to sit on the floor to be tested and place their bare feet flat on the test stand. The subject will be asked to lean forward from the body and will extend his/her hands in front of his body as far forward as he can without bending his knees. The farthest point shown by the fingertip will be measured with the help of a tape measure.	Eight weeks
Secondary	Grip Strength	Grip Strength is evaluates the strength of the hand muscles used to grasp. In the test procedure, three measurements are made for hand grip strength,and the averages are recorded separately for right and left.	Eight weeks
Secondary	Pittsburgh Sleep Quality Index	Pittsburgh sleep quality index, consists of 19 items grouped according to seven component scores. Scores on the seven components are then summed to give a global Pittburgh Sleep Quality Index score ranging from 0 to 21. Scores between 0 and 4 indicate good sleep quality, scores between 5 and 10 indicate poor quality, and above 10 indicate sleep disturbance.	Eight weeks
Secondary	6-Minute Walk Test	The 6-minute walk test measures the maximum distance in meters that a person can walk as fast as possible over a 6-minute period.	Eight weeks
Secondary	Perceived Stress Scale	Perceived stress scale, is a 10-item that assesses the amount of perceived psychological stress during the past month. Participants evaluate each item on a 5-point Likert-type scale ranging from "Never (0)" to "Very often (4)". A high score indicates a person's perception of stress is high	eight weeks
Secondary	The Fatigue Severity Scale	The fatigue severity scale, evaluates how fatigue affects motivation, exercise, physical functioning, performance of tasks, work, family and social life. It is scored on a 7-point Likert scale. A total score is 9-63 , and a score of 36 and above indicates severe fatigue.	Eight weeks