Effects of Underwater Ultrasound Therapy on Hand Function and Quality of Life in Patients With Rheumatoid Arthritis - a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- change in erythrocyte sedimentation rate
研究概览
简要总结
In this randomized, double-blind, placebo-controlled study the effects of underwater ultrasound (US) therapy were investigated in 48 patients with moderately active rheumatoid arthritis (disease activity score in 28 joints (DAS28) ≥3.2 and ≤5.1).
Patients randomly assigned to the ultrasound group (N=25) received underwater ultrasound therapy to both wrists and hands for 7 minutes per session with an intensity of 0.7 W/cm2 during 10 sessions. The control group (N=23) received sham treatment under the same conditions. At baseline, at the end of treatment (Week 2) and at the follow-up visit (Week 14), the following parameters were evaluated: disease activity - erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), tender and swollen joint counts, pain on a visual analogue scale, and DAS28, hand function (fist making, wrist extension and flexion, hand grip strength), quality of life - Health Assessment Questionnaire (HAQ), and the patients rated their own condition.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age with mild-to-moderate (DAS28 > 3.2 and < 5.1) rheumatoid arthritis meeting the American College of Rheumatology (ACR) diagnostic criteria
- •No distinction was made between seropositive and seronegative patients (regarding rheumatoid factor and anti-citrullinated peptide antibody)
- •a stable-dose pharmacotherapy (DMARDs therapy), NSAIDs, steroid) given for at least 2 months
- •no physiotherapy within 1 month before starting the study
排除标准
- •included high disease activity (DAS28 > 5.1) and remission (DAS28 < 2.6)
- •other concomitant autoimmune diseases
- •stable-dose pharmacotherapy for less than 2 months
- •conditions contraindicating US therapy (severe osteoporosis when T-score < -3.5; infection; fever; osteomyelitis; pregnancy; untreated high blood pressure)
- •physiotherapy within 1 month before starting the study
结局指标
主要结局
change in erythrocyte sedimentation rate
时间窗: week 0 and week 14
change from baseline erythrocyte sedimentation rate (ESR) at Week 14
change in disease activity
时间窗: week 0 and week 14
change from baseline disease activity score (DAS28) at week 14
change in severity of pain at rest
时间窗: week 0 and week 14
change from baseline severity of pain at rest recorded on a 10 cm visual analogue scale (VAS) at week 14
change in duration of morning stiffness
时间窗: week 0 nd week 14
change from baseline duration of morning joint stiffness (minutes) at Week 14
change in C-reactive protein
时间窗: week 0 and week 14
change from baseline C-reactive protein (CRP) at Week 14
change in number of painful and swollen joints
时间窗: week 0 and week 14
change from baseline number of painful and swollen joints at week 14
次要结局
- change in joint function (range of motion of the wrist)(week 0 and week 14)
- change in degree of fist making(week 0 and week14)
- change in hand grip strength(week 0 and week 14)
- change in quality of life(week 0 and week 2)
- change from baseline quality of life(week 0 and week 14)
研究者
Márta Király
chief physician
Petz Aladar County Teaching Hospital