Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia
- Conditions
- FibromyalgiaVestibular DiseasePostural BalanceVestibular Rehabilitation
- Interventions
- Other: Vestibular Rehabilitation ExercisesOther: Conventional Rehabilitation exercises
- Registration Number
- NCT05300529
- Lead Sponsor
- University of Jaén
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- Aged 18-70 years,
- Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vestibular Rehabilitation Exercises Vestibular Rehabilitation Exercises Vestibular Rehabilitation Exercises focused on eye stabilization and Vestibulo-Oculo Reflex (VOR). Two sessions/week supervised by researcher (40 min) and conducting exercises at home 2 times/day, 5 days/week. (15-20 min) Conventional Rehabilitation exercises Conventional Rehabilitation exercises Conventional rehabilitation exercises: stretching and walking. Two sessions/week supervised by researcher (40 min) and conducting exercises at home 2 times/day, 5 days/week. (15-20 min)
- Primary Outcome Measures
Name Time Method DHI (Dizziness Handicap Inventory) 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) 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) 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 Outcome Measures
Name Time Method CSI (Central Sensitization Inventory) at twelve weeks. Evaluates a wide range of somatic and emotional symptoms common to central sensitization syndromes (CSS). The total score of the CSI from 0 to 100. Higher scores indicate greater severity of symptoms.
SVV (Subjective Visual Vertical) at twelve weeks Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
VAS-pain (Visual Analogue Scale) at twelve weeks Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
FSS (Fatigue Severity Scale) at twelve weeks Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
20-item JAEN screening tool at twelve weeks Evaluates balance and neuromotor function in patients with fibromyalgia. Thd total scale of the Jaen-Screening Tools, from 0 to 80 points. A higher score indicates a greater degree of balance disorder.
Satisfaction level at eight weeks Evaluates the level of satisfaction using a Likert scale, with five response options, from "very dissatisfied" to "very satisfied". The total score of 0-24. A high score indicates greater satisfaction
GRC (Global Change Rating Scales) at eight weeks Assesses whether the patient's health status has improved or deteriorated after the treatment received, with ten response options ranging from "the worst it could be" to "the best it could be"
PCS (Pain Catastrophizing Scale) at twelve weeks. Evaluates the patient's catastrophic thoughts. The total score of the PCS from 0 to 52. Higher scores indicate a greater presence of catastrophic thoughts.
SF-12 (12-Item Short Form Survey) at twelve weeks Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.
FES-I (Falls Efficacy Scale-International) at twelve weeks Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.
Stabilometric Platform at twelve weeks Instrument composed of resistive pressure sensors, used to measure the static or postural balance. The test was performed under both eyes-open and eyes-closed conditions.
TSK (Tampa Scale for Kinesiophobia) at twelve weeks. Evaluates fear of movement to injury. The total score of the TSK from 11 to 44 points. Higher scores indicate a greater fear of movement.
Therapeutic Adherence at home Throughout the intervention phase, eight weeks It assesses adherence to home treatment through a weekly record diary, where patients must record the number of times a day they perform the prescribed exercises, with a range of 0 to 80. Higher scores indicate greater adherence to home treatment. A score of 80 indicates 100% adherence.
Trial Locations
- Locations (1)
University os Jaén
🇪🇸Jaén, Spain