Effects of Mobilization and Perceptive Rehabilitation on Disability and Symptoms of Patients With Fibromyalgia Syndrome- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Revised-Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
The aim of our study is to determine and compare the effects of perceptive rehabilitation against other mobilization techniques on the treatment of fibromyalgia symptoms and disability. Participants in this study will be randomly assigned to three separate groups using a random allocation software program, the three groups receiving either perceptive rehabilitation (PR-group), mobilization techniques (Mob-group), or neither (the control group, C-group).
详细描述
Fibromyalgia is considered to be a chronic, widespread musculoskeletal pain syndrome. Its most common symptoms are fatigue, anxiety, depression, and lack of concentration. These symptoms may lead to a decrease in the amount of physical activity that a sufferer can accomplish. Neck and back pain will also increase as the sedentary behaviour becomes the norm (Talotta et al., 2017). The best overall way of managing fibromyalgia is still under discussion, but according to the literature, symptoms are best managed by physiotherapy (García, Nicolás, and Hernández, 2016). Different programs can also be tailored to individual fibromyalgia sufferers with the aim of reducing pain (e.g. heat agents, electrotherapy, postural exercises, aerobic exercise, aqua-therapy and manual treatment).
However, according to Bronfort et al. (2010), there is insufficient evidence supporting the effectiveness of manual therapy as a treatment for fibromyalgia. According to Reis et al. (2014), a single thoracic mobilization session was able to improve short-term heart-rate variability, although the pain was not affected by the intervention.
Paolucci et al. (2016) used a new rehabilitation tool to treat pain with an increased reliance on proprioception. Practically, the tool consisted of cones made from a latex material which were placed under the patient's back during treatment sessions. These cones were intended to improve tactile response and proprioception, the so-called perceptual surface. According to this study, the tool was able to decrease pain and help to improve function. However, it is important to understand the tool's effect on long-term rehabilitation and compare it with other treatment methods. The aim of our study is to determine and compare the effects of perceptive rehabilitation and mobilization techniques on disability and fibromyalgia symptoms.
Our study will include 90 participants, with 30 participants in each group. The PR-group and the Mob-group will receive treatments twice per week for eight weeks, a total of 16 sessions; there will be no intervention in the C-group. Another physiotherapist will assess each group before and after all the sessions. The study will be single blind. Follow-up assessments will be three and six months after the last session.
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 (Outcomes Assessor)
盲法说明
Outcome measures will be performed by an experienced physiotherapist who will be blinded to the group allocation.
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a Fibromyalgia diagnosis according to Wolfe et al. (2016) criteria.
排除标准
- •Having a diagnosis of chronic fatigue syndrome or myofascial pain syndrome,
- •Using medicine other than simple analgesics,
- •Vertebrobasilar insufficiency,
- •Severe scoliosis or kyphoscoliosis,
- •History of spine surgery,
- •History of vertebral fracture,
- •Rheumatic diseases,
- •History of Benign or Malign tumour,
- •Osteoporosis and conditions that cause osteoporosis,
- •Presence of cardiovascular risk factors,
- •Serious neurological problems,
- •Psychiatric disorders,
- •Chronic respiratory diseases,
- •After upper motor neurone lesion,
- •Attending regular physical activity or exercise class during the last 3 months.
结局指标
主要结局
Revised-Fibromyalgia Impact Questionnaire (FIQR)
时间窗: change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period
Turkish version of FIQR will be use in this study. This questionnaire has 21 individual questions. All these questions should be answered according to the past 7 days. FIQR has divided to three sections; 'function, overall impact and symptoms'. The total FIQR score will be calculate with the sum of the three domain scores.
次要结局
- Postural assessment 2(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Postural assessment 1(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Pressure pain threshold and toleration(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Beck Depression Inventory (BDI)(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Pittsburgh Sleep Quality Index (PSQI)(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Body Mass Index (BMI)(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Short form of McGill pain questionnaire (SF-MPQ)(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Fatigue Severity Scale (FSS)(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Socio-demographic and clinical characteristics(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Cervical flexibility tests(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
- Cervical joint position sense(change from baseline to the end of the 8 weeks, at the end of the 3-month and 6-month follow-up period)
研究者
Beraat Alptug
Master Physiotherapist
European University of Lefke