Efficacy of Telerehabilitation and Multicomponent Therapy in Women With Fibromyalgia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
In this prospective, randomized study, our aim was to evaluate the comprehensive multicomponent treatment of fibromyalgia women with telerehabilitation, including "patient education, special psychotherapy/psychosocial intervention, and exercise including relaxation exercises". Does it differ in terms of reduction and functionality?
详细描述
Patients who meet the inclusion criteria will be randomized into two groups by computer program after being numbered according to the order of application. 33 patients in the multicomponent treatment group selected to group 1 (G1) will be treated with telerehabilitation for a total of 6 sessions of two hours once a week for 3 weeks. After 1 month, one more session will be applied for a two-hour follow-up and sustainability. As a control group, 33 patients selected to Group 2 (G2) will be given exercise and training with telerehabilitation.
Patients to whom a multicomponent treatment program will be applied will be included in the program in groups of 10. The presentations will be prepared as power-point presentations and will be presented to the patients online with telerehabilitation.
Interventions to be applied in the multicomponent treatment protocol:
- Patient education
- Exercise training
- Private Psychotherapy
- Relaxation
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Symptom persistence for more than 3 months
- •Pervasive Network Scale Score >7 and Symptom Severity Score >5 according to 2016 ACR criteria
- •Symptom Severity Score of >9 and Diffuse Pain Scale Score between 4-6 according to 2016 ACR criteria
- •Getting a high (11 and above) score on the Hospital Anxiety and Depression Scale
- •Having the opportunity to participate in the applications online
- •No change in the medical treatment he received for fibromyalgia syndrome during the study period
- •Those between the ages of 18-55
排除标准
- •Patients with endocrine, neuromuscular, infectious and inflammatory rheumatological diseases
- •Patients with liver or kidney disease
- •Patients with malignancy
- •Patients with a history of severe trauma
- •Patients with severe psychiatric illness
- •Patients with serious physical comorbidities
- •The illiterate
- •Known central nervous system or peripheral nervous system disease, progressive neurological deficit
- •Peripheral venous insufficiency, coagulopathies and anticoagulant drug use
- •Serious cardiovascular pathologies
- •Loss of sensation, loss of position sense, unhealed fracture or open surgical wound
结局指标
主要结局
change in The Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: Baseline (before intervention), 1 month after intervention, 3 months after the intervention
The fibromyalgia impact questionnaire was developed from information gathered from patient reports, functional status tools, and clinical observations. This questionnaire measures physical function, work status (days off and work difficulty), depression, anxiety, morning fatigue, pain, stiffness, fatigue, and well-being in the past week.
次要结局
- change in The Fatigue Severity Scale (FSS)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Pain Coping Inventory (PCI)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in ICF Core Set for Chronic Widespread Pain(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Jenkins Sleep Evaluation Questionnaire (JSEQ)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Visual Analogue Scale (VAS)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in The Central Sensitization (CSI) Inventory(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in hospital anxiety and depression scale(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Short Form-36 (SF-36)(Baseline (before intervention), 1 month after intervention, 3 months after the intervention)
- change in Pain Self Efficacy Questionnaire-2 (PSEQ-2)(Baseline (before intervention), after a month intervention, after 3 month the intervention)
研究者
DIREN OZER OZBEY
Principal Investigator
Istanbul University