Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Fibromyalgia
- Sponsor
- University of Jaén
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- DHI (Dizziness Handicap Inventory)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to analyze the effectiveness of Vestibular Rehabilitation for improving balance and quality of life of patients with Fibromyalgia Syndrome (SFM). Recruited subjects will be randomly assigned to an experimental group or control group (placebo). The experimental group will receive a standard Vestibular Rehabilitation program focused on eye stabilization and Vestibulo-Ocular Reflex (VOR) gain with the aim of improving motor and sensory strategies, while the control group will carry out a conventional rehabilitation program that will not include sensory strategy training. The frequency of treatment for both groups will be twice/week, along with daily performing (2 times/day, 5 days/week) of exercises at home. The total duration will be 8 weeks. The outcome measure are: disease impact (FIQ), perceived vertigo (DHI), and confidence in balance (ABC), at pre-treatment, post-treatment, one month follow-up and three months follow-up.
Detailed Description
Fibromyalgia Syndrome (SFM) affects approximately 0.5 - 5% of the global population with ambiguity in diagnosis, physiopathology uncertainty and complex treatment. Recent studies have shown frequent episodes of postural instability in SFM patients. This balance affectation seems to correlate with disturbances of quality of life, pain, impact of the disease, daily life activities and increased risk of falls. However, there is still controversy over the exact mechanism that explains this nonspecific balance disorder. Despite this preliminary finding of a possible visual and vestibular disorder, there are not known studies justifying the alteration of vestibular functions present in Fibromyalgia. Also, the are not certainty that Vestibular Rehabilitation (VR) provides short- and medium-term benefits. Derived from the deficiencies observed in the revised literature, we propose to analyze the effectiveness of a Vestibular Rehabilitation program improving the balance and quality of life of people with Fibromyalgia Syndrome (SFM). Therefore, a randomized, simple blind, two-group parallel controlled clinical trial has been designed to assess the effectiveness of Vestibular Rehabilitation treatment focused on eye stabilization exercises. Subjects will be recruited from the Jaén Fibromyalgia Association (AFIXA) and randomly assigned to an experimental group or control group (placebo). Subjects who are diagnosed with SFM and between 18 and 70 years of age will be selected. The experimental group will receive a standard Vestibular Rehabilitation program focused on the stabilization of the eye and gain of the Vestibulo-Oculo Reflex (VOR), while in the control group a conventional rehabilitation program will be carried out without visual stimulation. The frequency of treatment for both groups will be twice/week, along with daily exercises at home (2 times/day). The total duration will be 8 weeks. Measurements will be made in pretreatment, aftertreatment and one month follow-up and three months follow-up.
Investigators
Ana Peinado Rubia
PhD student, principal investigator
University of Jaén
Eligibility Criteria
Inclusion Criteria
- •Aged 18-70 years,
- •Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)
Exclusion Criteria
- •Cognitive impairment impacting ability to fill out the scales and questionnaires.
- •Musculoskeletal surgical intervention in the preceding 6 months and/or acute traumatic pathology to the inferior limb(s).
- •Musculoskeletal disease with deformity of the inferior limbs.
- •Diagnosed with vestibular, visual and/or auditory pathology.
- •Neurologic illness that could be the cause of a balance disorder.
Outcomes
Primary Outcomes
DHI (Dizziness Handicap Inventory)
Time Frame: at twelve weeks.
Evaluates the level of disability related to the impact of dizziness on daily function and quality of life. The total score of the DHI is from 0 to100 points. A higher score indicates a greater degree of disability due to the vertiginous symptoms.
FIQ (Fibromyalgia Impact Questionnaire)
Time Frame: at twelve weeks
Evaluates the impact of fibromyalgia on the patient's quality of life.The total score of the FIQ is from 0 to 100. A higher score means a greater impact of the disease on the patient.
ABC-16 (Activities-specific Balance Confidence scale-16 items)
Time Frame: at twelve weeks
Evaluates the balance confidence in performing activities of daily living. The total score of the ABC-16 is from 0% to 100%, with higher values associated with higher balance confidence.
Secondary Outcomes
- CSI (Central Sensitization Inventory)(at twelve weeks.)
- SVV (Subjective Visual Vertical)(at twelve weeks)
- VAS-pain (Visual Analogue Scale)(at twelve weeks)
- FSS (Fatigue Severity Scale)(at twelve weeks)
- 20-item JAEN screening tool(at twelve weeks)
- Satisfaction level(at eight weeks)
- GRC (Global Change Rating Scales)(at eight weeks)
- PCS (Pain Catastrophizing Scale)(at twelve weeks.)
- SF-12 (12-Item Short Form Survey)(at twelve weeks)
- FES-I (Falls Efficacy Scale-International)(at twelve weeks)
- Stabilometric Platform(at twelve weeks)
- TSK (Tampa Scale for Kinesiophobia)(at twelve weeks.)
- Therapeutic Adherence at home(Throughout the intervention phase, eight weeks)