A New Rehabilitation Tool in Fibromyalgia
- Conditions
- FibromyalgiaPain
- Registration Number
- NCT02472093
- Lead Sponsor
- University of Roma La Sapienza
- Brief Summary
The aim of the investigators study was to measure reductions in chronic pain in female patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized chronic pain condition that is usually accompanied by fatigue, sleep disturbance and psychological and cognitive alterations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 88
- fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 1990 and 2010)
- Subjects aged between 18 and 60 years
- visual analog scale (VAS) for pain > 5
- presence of concomitant autoimmune diseases
- psychiatric disorders
- other causes of chronic pain
- other diseases that prevented physical loading
- severe scoliosis or kyphoscoliosis
- surgery of the spine
- vertebral fractures
- sciatic pain
- tumors
- enrolled in another type of physical therapy program
- myocardial infarction
- lower extremity arterial disease
- major neurological problems
- diabetes
- gastrointestinal disease
- chronic respiratory disease
- kidney disease
- poor vision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks baseline, 4 weeks, 12 weeks It is a simple and rapidly implemented index, consisting of a pain map, called the Self-Assessment Pain Scale (SAPS) (in which the patient is asked to indicate how much pain he suffered in the previous week in 16 areas of the body, with scored from 0 to 3), and 2 scales (between 0 and 10) that evaluate fatigue and quality of sleep, scored from 0-10. The FAS allows physicians to obtain reliable information concerning the course of the disease and is sufficiently sensitive to alert them in case of deterioration.
- Secondary Outcome Measures
Name Time Method Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks baseline, 4 weeks, 12 weeks It comprises 3 sections-function, impact, and symptoms-combining to generate an overall score. The first section contains 10 sub items and focuses on the patient's ability to perform daily tasks that involve the large muscles (eg, cooking, cleaning, walking, shopping, homemaking, socializing, and mobility). The next 2 items ask patients to circle the number of days in the past week in which they felt good and the number of days that they missed work. The last 7 items assess the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The total score on the FIQ is calculated by adding the following 10 items: the physical function score, the number of days feeling good, the number of work days missed, the ability to do one's job, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The FIQ score ranges from 0 to 100, with 100 indicating the worst possible score due to Fibromylgia.
Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks baseline, 4 weeks, 12 weeks It is a 20-item self-administered questionnaire that determines the difficulty in performing 8 daily activities (dressing and grooming, getting up, eating, walking, hygiene, reaching, ability to grip, and outside activities). For each item, patients are asked to rate the level of difficulty that they have experienced over the previous week in performing these activities on a 4-point scale from 0 (no difficulty) to 3 (unable to perform). The final HAQ score is the average score of the 8 categories, thus ranging from 0 to 3; higher scores reflect greater levels of disability.