Clinical trial NCT05300529: Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia
Official title: Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Vestibular Disease
Postural Balance
Vestibular Rehabilitation
Keywords: Fibromyalgia
Vestibular Disease
Postural Balance
Vestibular Rehabilitation
Lead sponsor: University of Jaén
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: Baseline
measure: FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: at eight weeks
measure: FIQ (Fibromyalgia Impact Questionnaire)
timeFrame: at twelve weeks
measure: ABC-16 (Activities-specific Balance Confidence scale-16 items)
timeFrame: Baseline
measure: ABC-16 (Activities-specific Balance Confidence scale-16 items)
timeFrame: at eight weeks
measure: ABC-16 (Activities-specific Balance Confidence scale-16 items)
timeFrame: at twelve weeks
measure: DHI (Dizziness Handicap Inventory)
timeFrame: Baseline
measure: DHI (Dizziness Handicap Inventory)
timeFrame: at eight weeks
measure: DHI (Dizziness Handicap Inventory)
timeFrame: at twelve weeks.
Secondary outcomes:
measure: CSI (Central Sensitization Inventory)
timeFrame: Baseline
measure: CSI (Central Sensitization Inventory)
timeFrame: at eight weeks
measure: CSI (Central Sensitization Inventory)
timeFrame: at twelve weeks.
measure: PCS (Pain Catastrophizing Scale)
timeFrame: Baseline
measure: PCS (Pain Catastrophizing Scale)
timeFrame: at eight weeks
measure: PCS (Pain Catastrophizing Scale)
timeFrame: at twelve weeks.
measure: TSK (Tampa Scale for Kinesiophobia)
timeFrame: Baseline
measure: TSK (Tampa Scale for Kinesiophobia)
timeFrame: at eight weeks
measure: TSK (Tampa Scale for Kinesiophobia)
timeFrame: at twelve weeks.
measure: VAS-pain (Visual Analogue Scale)
timeFrame: Baseline
measure: VAS-pain (Visual Analogue Scale)
timeFrame: at eight weeks
measure: VAS-pain (Visual Analogue Scale)
timeFrame: at twelve weeks
measure: SF-12 (12-Item Short Form Survey)
timeFrame: Baseline
measure: SF-12 (12-Item Short Form Survey)
timeFrame: at eight weeks
measure: SF-12 (12-Item Short Form Survey)
timeFrame: at twelve weeks
measure: FES-I (Falls Efficacy Scale-International)
timeFrame: Baseline
measure: FES-I (Falls Efficacy Scale-International)
timeFrame: at eight weeks
measure: FES-I (Falls Efficacy Scale-International)
timeFrame: at twelve weeks
measure: FSS (Fatigue Severity Scale)
timeFrame: Baseline
measure: FSS (Fatigue Severity Scale)
timeFrame: at eight weeks
measure: FSS (Fatigue Severity Scale)
timeFrame: at twelve weeks
measure: 20-item JAEN screening tool
timeFrame: Baseline
measure: 20-item JAEN screening tool
timeFrame: at eight weeks
measure: 20-item JAEN screening tool
timeFrame: at twelve weeks
measure: SVV (Subjective Visual Vertical)
timeFrame: baseline
measure: SVV (Subjective Visual Vertical)
timeFrame: at eight weeks
measure: SVV (Subjective Visual Vertical)
timeFrame: at twelve weeks
measure: Stabilometric Platform
timeFrame: Baseline
measure: Stabilometric Platform
timeFrame: at eight weeks
measure: Stabilometric Platform
timeFrame: at twelve weeks
measure: Therapeutic Adherence at home
timeFrame: Throughout the intervention phase, eight weeks
measure: Satisfaction level
timeFrame: at eight weeks
measure: GRC (Global Change Rating Scales)
timeFrame: at eight weeks
Other outcomes:
measure: Height (Anthropometrics Data)
timeFrame: Baseline
measure: Weight (Anthropometrics Data)
timeFrame: Baseline
measure: Body Mass Index (Anthropometrics Data)
timeFrame: Baseline
measure: Demographics Data
timeFrame: Baseline
Locations:
city: Jaén
country: Spain
facility: University os Jaén
Study officials:
affiliation: University of Jaén
name: Rafael Lomas-Vega, PhD
role: PRINCIPAL_INVESTIGATOR
References: