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Completed

NCT Number: NCT05300529

Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Ear Diseases Labyrinth Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Otorhinolaryngologic Diseases Postural Balance Rheumatic Diseases Vestibular Disease Vestibular Diseases Vestibular Rehabilitation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University os Jaén

Jaén, 23071, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vestibular Rehabilitation Exercises

Other

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.

Conventional Rehabilitation exercises

Other

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. VAS-pain (Visual Analogue Scale)

    Time frame: Baseline

    Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain

  11. VAS-pain (Visual Analogue Scale)

    Time frame: at eight weeks

    Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain

  12. VAS-pain (Visual Analogue Scale)

    Time frame: at twelve weeks

    Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain

  13. SF-12 (12-Item Short Form Survey)

    Time frame: Baseline

    Evaluates the impact of health on an individual's everyday life. Used as a quality of life measure.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. FSS (Fatigue Severity Scale)

    Time frame: Baseline

    Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue

  20. FSS (Fatigue Severity Scale)

    Time frame: at eight weeks

    Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue

  21. FSS (Fatigue Severity Scale)

    Time frame: at twelve weeks

    Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. SVV (Subjective Visual Vertical)

    Time frame: at eight weeks

    Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.

  27. 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.

  28. 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.

  29. 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.

  30. 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.

  31. 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.

  32. 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

  33. 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"

Other outcomes

  1. Height (Anthropometrics Data)

    Time frame: Baseline

    Patient height measured in meters (m)

  2. Weight (Anthropometrics Data)

    Time frame: Baseline

    Patient's body weight in kilograms (kg)

  3. Body Mass Index (Anthropometrics Data)

    Time frame: Baseline

    Weight and height will be combined to report body mass index in kg/m^2

  4. Demographics Data

    Time frame: Baseline

    Registration of information provided by the patient on sex, age, education level. occupation and civil status

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 29, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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