An interventional study of Vestibular Rehabilitation Exercises and Conventional Rehabilitation exercises in Fibromyalgia, Vestibular Disease and Postural Balance, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by University of Jaén · Not applicable, Interventional, and Treatment
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.
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 35 is below the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
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Exclusion Criteria:
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)
Other: Vestibular 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)
Other: Conventional Rehabilitation exercises
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.
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
FIQ (Fibromyalgia Impact Questionnaire)
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.
Time frame: Baseline
FIQ (Fibromyalgia Impact Questionnaire)
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.
Time frame: at eight weeks
FIQ (Fibromyalgia Impact Questionnaire)
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.
Time frame: at twelve weeks
ABC-16 (Activities-specific Balance Confidence scale-16 items)
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.
Time frame: Baseline
ABC-16 (Activities-specific Balance Confidence scale-16 items)
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.
Time frame: at eight weeks
ABC-16 (Activities-specific Balance Confidence scale-16 items)
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.
Time frame: at twelve weeks
DHI (Dizziness Handicap Inventory)
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.
Time frame: Baseline
DHI (Dizziness Handicap Inventory)
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.
Time frame: at eight weeks
DHI (Dizziness Handicap Inventory)
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.
Time frame: at twelve weeks.
CSI (Central Sensitization Inventory)
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.
Time frame: Baseline
CSI (Central Sensitization Inventory)
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.
Time frame: at eight weeks
CSI (Central Sensitization Inventory)
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.
Time frame: at twelve weeks.
PCS (Pain Catastrophizing Scale)
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.
Time frame: Baseline
PCS (Pain Catastrophizing Scale)
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.
Time frame: at eight weeks
PCS (Pain Catastrophizing Scale)
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.
Time frame: at twelve weeks.
TSK (Tampa Scale for Kinesiophobia)
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.
Time frame: Baseline
TSK (Tampa Scale for Kinesiophobia)
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.
Time frame: at eight weeks
TSK (Tampa Scale for Kinesiophobia)
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.
Time frame: at twelve weeks.
VAS-pain (Visual Analogue Scale)
Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
Time frame: Baseline
VAS-pain (Visual Analogue Scale)
Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
Time frame: at eight weeks
VAS-pain (Visual Analogue Scale)
Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
Time frame: at twelve weeks
SF-12 (12-Item Short Form Survey)
Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.
Time frame: Baseline
SF-12 (12-Item Short Form Survey)
Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.
Time frame: at eight weeks
SF-12 (12-Item Short Form Survey)
Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.
Time frame: at twelve weeks
FES-I (Falls Efficacy Scale-International)
Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.
Time frame: Baseline
FES-I (Falls Efficacy Scale-International)
Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.
Time frame: at eight weeks
FES-I (Falls Efficacy Scale-International)
Evaluates the fear of falling. The total score of the FES-I from 16 to 64 points. Higher scores indicate greater fear of falling.
Time frame: at twelve weeks
FSS (Fatigue Severity Scale)
Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
Time frame: Baseline
FSS (Fatigue Severity Scale)
Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
Time frame: at eight weeks
FSS (Fatigue Severity Scale)
Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
Time frame: at twelve weeks
20-item JAEN screening tool
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.
Time frame: Baseline
20-item JAEN screening tool
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.
Time frame: at eight weeks
20-item JAEN screening tool
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.
Time frame: at twelve weeks
SVV (Subjective Visual Vertical)
Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
Time frame: baseline
SVV (Subjective Visual Vertical)
Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
Time frame: at eight weeks
SVV (Subjective Visual Vertical)
Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
Time frame: at twelve weeks
Stabilometric Platform
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.
Time frame: Baseline
Stabilometric Platform
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.
Time frame: at eight weeks
Stabilometric Platform
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.
Time frame: at twelve weeks
Therapeutic Adherence at home
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.
Time frame: Throughout the intervention phase, eight weeks
Satisfaction level
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
Time frame: at eight weeks
GRC (Global Change Rating Scales)
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"
Time frame: at eight weeks
Height (Anthropometrics Data)
Patient height measured in meters (m)
Time frame: Baseline
Weight (Anthropometrics Data)
Patient's body weight in kilograms (kg)
Time frame: Baseline
Body Mass Index (Anthropometrics Data)
Weight and height will be combined to report body mass index in kg/m\^2
Time frame: Baseline
Demographics Data
Registration of information provided by the patient on sex, age, education level. occupation and civil status
Time frame: Baseline
Plan to share: No
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