Effectiveness of Vestibular Rehabilitation for Improving Health Status in Patients With Fibromyalgia. Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- DHI (Dizziness Handicap Inventory)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years,
- •Diagnostic for fibromyalgia as described by the 2016 American College of Rheumatology (ACR)
排除标准
- •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.
结局指标
主要结局
DHI (Dizziness Handicap Inventory)
时间窗: 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.
FIQ (Fibromyalgia Impact Questionnaire)
时间窗: 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)
时间窗: 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.
次要结局
- CSI (Central Sensitization Inventory)(at twelve weeks.)
- SVV (Subjective Visual Vertical)(at twelve weeks)
- VAS-pain (Visual Analogue Scale)(at twelve weeks)
- FSS (Fatigue Severity Scale)(at twelve weeks)
- 20-item JAEN screening tool(at twelve weeks)
- Satisfaction level(at eight weeks)
- GRC (Global Change Rating Scales)(at eight weeks)
- PCS (Pain Catastrophizing Scale)(at twelve weeks.)
- SF-12 (12-Item Short Form Survey)(at twelve weeks)
- FES-I (Falls Efficacy Scale-International)(at twelve weeks)
- Stabilometric Platform(at twelve weeks)
- TSK (Tampa Scale for Kinesiophobia)(at twelve weeks.)
- Therapeutic Adherence at home(Throughout the intervention phase, eight weeks)
研究者
Ana Peinado Rubia
PhD student, principal investigator
University of Jaén