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

NCT ID: NCT05300529

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-04-01

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.

Conditions

Fibromyalgia; Vestibular Disease; Postural Balance; Vestibular Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: EXPERIMENTAL

Vestibular Rehabilitation Exercises

Intervention Type: 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

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)

Group Type: SHAM_COMPARATOR

Conventional Rehabilitation exercises

Intervention Type: 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

Interventions

Vestibular 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.

Intervention Type: OTHER

Conventional Rehabilitation exercises

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Jaén

OTHER

Sponsor Role: lead

Responsible Party

Ana Peinado Rubia

PhD student, principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rafael Lomas-Vega, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Jaén

Locations

University os Jaén

Jaén, , Spain

Countries

Spain

Other Identifiers

UjaFM

Identifier Type: -

Identifier Source: org_study_id