Fibromyalgia
Conditions
Keywords
fibromyalgia, progressive muscle relaxation, combined exercise, rehabilitation
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.
Interventions
OTHERcombined 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.
OTHERcombined 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.
Sponsors
Abant Izzet Baysal University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
There will be an intervention and control group in the study.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale | 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. |
| The Pain Catastrophizing Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COMPASS 31 Scale: | Eight weeks | 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). |
| Skin Temperature | Eight weeks | 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). |
| Saturation | Eight weeks | Saturation will be measured with a pulse oximeter attached to the fingertip. |
| Blood Pressure | Eight weeks | The patients' blood pressure will be measured with a sphygmomanometer |
| The Respiratory Frequency | Eight weeks | The respiratory frequency value will be obtained by multiplying the number of breaths in and out for thirty seconds by two. |
| Pulse | Eight weeks | Pulse will be measured with a pulse oximeter attached to the fingertip. |
| Grip Strength | Eight weeks | 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. |
| Pittsburgh Sleep Quality Index | Eight weeks | 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 İndex 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. |
| 6-Minute Walk Test | Eight weeks | 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. |
| Perceived Stress Scale | eight weeks | 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 |
| The Fatigue Severity Scale | Eight weeks | 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. |
| Sit and Reach Test | Eight weeks | 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. |
| The Fibromyalgia Impact Scale | Eight weeks | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed