A New Rehabilitation Tool in Fibromyalgia: Efficacy of Perceptive Rehabilitation Versus Group Exercises on Pain and Function: a Clinical Randomized Controlled Trial (RCT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 88
- Primary Endpoint
- Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Teresa Paolucci
medical director
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •enrolled in another type of physical therapy program
- •myocardial infarction
Outcomes
Primary Outcomes
Change of Fibromyalgia Assessment Scale (FAS) from baseline to 12 weeks
Time Frame: 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 Outcomes
- Change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)
- Change of Health Assessment Questionnaire (HAQ) from baseline to 12 weeks(baseline, 4 weeks, 12 weeks)