- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05300529
Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia
Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Jaén, Spain, 23071
- University os Jaén
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
The Vestibular Rehabilitation program focuses on stabilizing the gaze and gaining the Vestibular Ocular Reflex (VOR).
The general mechanisms of recovery from vestibular injuries are vestibular adaptation and replacement exercises, which are designed to improve gaze stability and the interaction between sight and the vestibular system during head movements.
The exercises will be carried out progressively according to the tolerance of the patient, varying the stimulus in intensity and frequency.
|
Sham Comparator: 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)
|
The conventional rehabilitation program in which exercises are performed to improve joint range, flexibility, and gait.
It will always be done with the eyes open, on a firm surface and will not include training in sensory strategies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FIQ (Fibromyalgia Impact Questionnaire)
Time Frame: Baseline
|
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.
|
Baseline
|
FIQ (Fibromyalgia Impact Questionnaire)
Time Frame: at eight 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.
|
at eight weeks
|
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.
|
at twelve weeks
|
ABC-16 (Activities-specific Balance Confidence scale-16 items)
Time Frame: Baseline
|
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.
|
Baseline
|
ABC-16 (Activities-specific Balance Confidence scale-16 items)
Time Frame: at eight 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.
|
at eight weeks
|
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.
|
at twelve weeks
|
DHI (Dizziness Handicap Inventory)
Time Frame: Baseline
|
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.
|
Baseline
|
DHI (Dizziness Handicap Inventory)
Time Frame: at eight 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.
|
at eight weeks
|
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.
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at twelve weeks.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CSI (Central Sensitization Inventory)
Time Frame: Baseline
|
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.
|
Baseline
|
CSI (Central Sensitization Inventory)
Time Frame: at eight 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.
|
at eight weeks
|
CSI (Central Sensitization Inventory)
Time Frame: 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.
|
at twelve weeks.
|
PCS (Pain Catastrophizing Scale)
Time Frame: Baseline
|
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.
|
Baseline
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PCS (Pain Catastrophizing Scale)
Time Frame: at eight 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.
|
at eight weeks
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PCS (Pain Catastrophizing Scale)
Time Frame: 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.
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at twelve weeks.
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TSK (Tampa Scale for Kinesiophobia)
Time Frame: Baseline
|
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.
|
Baseline
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TSK (Tampa Scale for Kinesiophobia)
Time Frame: at eight 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.
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at eight weeks
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TSK (Tampa Scale for Kinesiophobia)
Time Frame: 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.
|
at twelve weeks.
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VAS-pain (Visual Analogue Scale)
Time Frame: Baseline
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Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
|
Baseline
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VAS-pain (Visual Analogue Scale)
Time Frame: at eight weeks
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Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
|
at eight weeks
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VAS-pain (Visual Analogue Scale)
Time Frame: at twelve weeks
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Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
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at twelve weeks
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SF-12 (12-Item Short Form Survey)
Time Frame: Baseline
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Evaluates the impact of health on an individual's everyday life.
Used as a quality of life measure.
|
Baseline
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SF-12 (12-Item Short Form Survey)
Time Frame: at eight weeks
|
Evaluates the impact of health on an individual's everyday life.
Used as a quality of life measure.
|
at eight weeks
|
SF-12 (12-Item Short Form Survey)
Time Frame: at twelve weeks
|
Evaluates the impact of health on an individual's everyday life.
Used as a quality of life measure.
|
at twelve weeks
|
FES-I (Falls Efficacy Scale-International)
Time Frame: Baseline
|
Evaluates the fear of falling.
The total score of the FES-I from 16 to 64 points.
Higher scores indicate greater fear of falling.
|
Baseline
|
FES-I (Falls Efficacy Scale-International)
Time Frame: at eight 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.
|
at eight weeks
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FES-I (Falls Efficacy Scale-International)
Time Frame: 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.
|
at twelve weeks
|
FSS (Fatigue Severity Scale)
Time Frame: Baseline
|
Evaluates severity of fatigue.
Higher scores indicate a greater severity of fatigue
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Baseline
|
FSS (Fatigue Severity Scale)
Time Frame: at eight weeks
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Evaluates severity of fatigue.
Higher scores indicate a greater severity of fatigue
|
at eight weeks
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FSS (Fatigue Severity Scale)
Time Frame: at twelve weeks
|
Evaluates severity of fatigue.
Higher scores indicate a greater severity of fatigue
|
at twelve weeks
|
20-item JAEN screening tool
Time Frame: Baseline
|
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.
|
Baseline
|
20-item JAEN screening tool
Time Frame: at eight 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.
|
at eight weeks
|
20-item JAEN screening tool
Time Frame: 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.
|
at twelve weeks
|
SVV (Subjective Visual Vertical)
Time Frame: baseline
|
Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
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baseline
|
SVV (Subjective Visual Vertical)
Time Frame: at eight weeks
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Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
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at eight weeks
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SVV (Subjective Visual Vertical)
Time Frame: at twelve weeks
|
Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
|
at twelve weeks
|
Stabilometric Platform
Time Frame: Baseline
|
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.
|
Baseline
|
Stabilometric Platform
Time Frame: at eight 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.
|
at eight weeks
|
Stabilometric Platform
Time Frame: 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.
|
at twelve weeks
|
Therapeutic Adherence at home
Time Frame: 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.
|
Throughout the intervention phase, eight weeks
|
Satisfaction level
Time Frame: 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
|
at eight weeks
|
GRC (Global Change Rating Scales)
Time Frame: 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"
|
at eight weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Height (Anthropometrics Data)
Time Frame: Baseline
|
Patient height measured in meters (m)
|
Baseline
|
Weight (Anthropometrics Data)
Time Frame: Baseline
|
Patient's body weight in kilograms (kg)
|
Baseline
|
Body Mass Index (Anthropometrics Data)
Time Frame: Baseline
|
Weight and height will be combined to report body mass index in kg/m^2
|
Baseline
|
Demographics Data
Time Frame: Baseline
|
Registration of information provided by the patient on sex, age, education level.
occupation and civil status
|
Baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rafael Lomas-Vega, PhD, University of Jaén
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UjaFM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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