FibromyalgiaNCT05300529
Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia
A study testing Vestibular Rehabilitation Exercises and Conventional Rehabilitation exercises in people with Fibromyalgia and Vestibular Disease, run by University of Jaén at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia, Vestibular Disease, Postural Balance
- What is being tested?
- Vestibular Rehabilitation Exercises and Conventional Rehabilitation exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years,
- Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial
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.
Read the 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.
- Being tested
- Vestibular Rehabilitation Exercises, Conventional Rehabilitation exercises
- Keywords
- Fibromyalgia, Vestibular Disease, Postural Balance, Vestibular Rehabilitation
- Medical subject headings
- Fibromyalgia, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation ExercisesOther
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 exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Conventional Rehabilitation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at twelve weeks.
Secondary outcomes (33)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at twelve weeks.
VAS-pain (Visual Analogue Scale)
Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
Measured: Baseline
VAS-pain (Visual Analogue Scale)
Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
Measured: at eight weeks
VAS-pain (Visual Analogue Scale)
Evaluates the pain on a numerical scale from 0 to 10. Higher scores indicate more pain
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at twelve weeks
FSS (Fatigue Severity Scale)
Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
Measured: Baseline
FSS (Fatigue Severity Scale)
Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
Measured: at eight weeks
FSS (Fatigue Severity Scale)
Evaluates severity of fatigue. Higher scores indicate a greater severity of fatigue
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: baseline
SVV (Subjective Visual Vertical)
Evaluates the perception of verticality, measured using the Subjective Visual Vertical (SVV) test using a virtual reality device.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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"
Measured: at eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start1 Jun 2021
- Primary completion20 Dec 2021
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Peinado Rubia, University of Jaén
- Investigators
- Rafael Lomas-Vega, PhD, Principal investigator, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05300529
- Sponsor's protocol ID
- UjaFM
- Status last verified
- Oct 2022
- First submitted
- 24 Jan 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05300529
- Acronym / sponsor ID
- UjaFM
- Keywords
- Fibromyalgia, Vestibular Disease, Postural Balance, Vestibular Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation Exercises | Experimental | Other: Vestibular Rehabilitation ExercisesVestibular 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) |
| Conventional Rehabilitation exercises | Sham comparator | Other: Conventional Rehabilitation exercisesConventional 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-70 years,
- Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation ExercisesThe 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. | Other | Vestibular Rehabilitation Exercises |
| Conventional Rehabilitation exercisesThe 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 | Other | Conventional Rehabilitation exercises |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
33 secondary outcomes
CSI (Central Sensitization Inventory)
Time frame: Baseline
CSI (Central Sensitization Inventory)
Time frame: at eight weeks
CSI (Central Sensitization Inventory)
Time frame: at twelve weeks.
PCS (Pain Catastrophizing Scale)
Time frame: Baseline
PCS (Pain Catastrophizing Scale)
Time frame: at eight weeks
PCS (Pain Catastrophizing Scale)
Time frame: at twelve weeks.
TSK (Tampa Scale for Kinesiophobia)
Time frame: Baseline
TSK (Tampa Scale for Kinesiophobia)
Time frame: at eight weeks
TSK (Tampa Scale for Kinesiophobia)
Time frame: at twelve weeks.
VAS-pain (Visual Analogue Scale)
Time frame: Baseline
VAS-pain (Visual Analogue Scale)
Time frame: at eight weeks
VAS-pain (Visual Analogue Scale)
Time frame: at twelve weeks
SF-12 (12-Item Short Form Survey)
Time frame: Baseline
SF-12 (12-Item Short Form Survey)
Time frame: at eight weeks
SF-12 (12-Item Short Form Survey)
Time frame: at twelve weeks
FES-I (Falls Efficacy Scale-International)
Time frame: Baseline
FES-I (Falls Efficacy Scale-International)
Time frame: at eight weeks
FES-I (Falls Efficacy Scale-International)
Time frame: at twelve weeks
FSS (Fatigue Severity Scale)
Time frame: Baseline
FSS (Fatigue Severity Scale)
Time frame: at eight weeks
FSS (Fatigue Severity Scale)
Time frame: at twelve weeks
20-item JAEN screening tool
Time frame: Baseline
20-item JAEN screening tool
Time frame: at eight weeks
20-item JAEN screening tool
Time frame: at twelve weeks
SVV (Subjective Visual Vertical)
Time frame: baseline
SVV (Subjective Visual Vertical)
Time frame: at eight weeks
SVV (Subjective Visual Vertical)
Time frame: at twelve weeks
Stabilometric Platform
Time frame: Baseline
Stabilometric Platform
Time frame: at eight weeks
Stabilometric Platform
Time frame: at twelve weeks
Therapeutic Adherence at home
Time frame: Throughout the intervention phase, eight weeks
Satisfaction level
Time frame: at eight weeks
GRC (Global Change Rating Scales)
Time frame: at eight weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rafael Lomas-Vega, PhD principal investigator
University of Jaén
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation Exercises and Conventional Rehabilitation exercises in people with Fibromyalgia and Vestibular Disease, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FIQ (Fibromyalgia Impact Questionnaire) (time frame: Baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.