Is Fluidotherapy Effective in Rheumatoid Hand? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 主要终点
- Duruöz Hand Index (DHI)
研究概览
简要总结
The objective of this study is to evaluate the efficacy of fluidotherapy primarily on function and quality of life, secondarily on pain, morning stiffness, grip strength, and disease activity in patients with rheumatoid hand.Ninety-three patients were enrolled in this prospective, single-blind, randomized, and controlled trial. Patients were randomized into 2 groups. Group 1 (n=47) had fluidotherapy (5 times per week, for 3-week duration) and Group 2 (n=46) was the control group. All patients received joint protection and exercise program. The primary outcome measures were Health Assessment Questionnaire (HAQ) and Duruöz Hand Index (DHI) and secondary outcome measures were pain and morning stiffness assessed using the Visual Analog Scale (VAS, 0-100 mm), the Grip Ability Test (GAT), Disease Activity Score-28 (DAS-28), and grip strength. These assessments were performed at baseline, at week 3 and week 12 after treatment.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18-75 years RA diagnosis fulfilling ACR 2010 criteria
- •disease duration for at least 6 months
- •no high disease activity and no acute arthritis in the hand according to DAS-28
- •hand problem specified with pain and loss of function in the hand
- •being in an eligible sociocultural and socioeconomic state so as to be able to come to the ambulatory treatment program
排除标准
- •change of medication within the last 3 months or during the study (except for non-steroidal anti-inflammatory drugs and paracetamol)
- •changes in oral corticosteroid dose in the last month, intraarticular or intramuscular corticosteroid use
- •hand or upper extremity surgery in the last 6 months
- •previous injury in the hand or upper extremity in the last 6 months
- •pregnancy
- •presence of sensory defects in the hand
- •presence of cognitive and/or psychiatric disease
- •physical therapy for the hand in the last 3 months.
研究组 & 干预措施
Fluidotherapy treatment
Patients who received fluidotherapy and joint protection and exercise
干预措施: Fluidotherapy treatment (Other)
Fluidotherapy treatment
Patients who received fluidotherapy and joint protection and exercise
干预措施: Joint protection and exercise (Other)
Joint protection and exercise
Patients who received joint protection and exercise
干预措施: Joint protection and exercise (Other)
结局指标
主要结局
Duruöz Hand Index (DHI)
时间窗: Change from Baseline. Duruöz Hand Index score at 3 weeks and 12 weeks
Health Assessment Questionnaire (HAQ)
时间窗: Change from Baseline, Health Assessment Questionnaire score at 3 weeks and 12 weeks
次要结局
- pain(baseline, at week 3 and week 12)
- stiffness(baseline, at week 3 and week 12)
- grip strength(baseline, at week 3 and week 12)
- Grip Ability Test (GAT)(baseline, at week 3 and week 12)
- Disease Activity Score-28 (DAS-28)(baseline, at week 3 and week 12)
研究者
Selmin Gulbahar
Clinical Professor and Head of Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Dokuz Eylul University
Dokuz Eylul University