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

NCT05300529 | Completed

• 1 other identifier: UjaFM
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Vestibular Disease; Postural Balance; Vestibular Rehabilitation

Keywords

Fibromyalgia; Vestibular Disease; Postural Balance; Vestibular Rehabilitation

Outcome Measures

Primary Outcomes (9)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  at twelve weeks.

Secondary Outcomes (33)

• CSI (Central Sensitization Inventory)

  Baseline

• CSI (Central Sensitization Inventory)

  at eight weeks

• CSI (Central Sensitization Inventory)

  at twelve weeks.

• PCS (Pain Catastrophizing Scale)

  Baseline

• PCS (Pain Catastrophizing Scale)

  at eight weeks

Other Outcomes (4)

• Height (Anthropometrics Data)

  Baseline

• Weight (Anthropometrics Data)

  Baseline

• Body Mass Index (Anthropometrics Data)

  Baseline

Study Arms (2)

Vestibular Rehabilitation Exercises

EXPERIMENTAL

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

SHAM COMPARATOR

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

Interventions

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.

Vestibular Rehabilitation Exercises

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

Conventional Rehabilitation exercises

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-70 years,
• Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

University os Jaén

Jaén, 23071, Spain

Location

MeSH Terms

Conditions

Fibromyalgia; Vestibular Diseases

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Rafael Lomas-Vega, PhD

  University of Jaén

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, principal investigator

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 29, 2022
• Study Start: June 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: April 1, 2022
• Last Updated: November 3, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)