Heated Mittens for Patients With Hand Osteoarthritis: 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
- 200
- 试验地点
- 2
- 主要终点
- Change in hand physical function
研究概览
简要总结
The primary objective of this trial is to assess the efficacy of an intervention with heated mittens in patients with hand osteoarthritis (HOA).
The joints of the hands are some of the most commonly joints affected by osteoarthritis, together with hip and knee joints. The prevalence increases with age and as the elderly population is growing so will the number of persons with HOA.
The primary symptoms for HOA are reduced function, stiffness and pain, with function being the most limiting factor for the patients.
Pharmacological treatments have some effect. Non-pharmacological treatments (such as exercise) have been investigated in a limited number of studies with overall minimal effect on the primary symptoms. In the earlier days the use of heating interventions, such as paraffin bath, was common treatment for patients with arthritis. During the last decades a shift from heating to exercise oriented treatment has occurred, however seemingly with limited effect on the primary symptoms. American College of Rheumatology (ACR) newest published guideline for the management of HOA (2020) recommend heating as a treatment among others but without scientific sound evidence for effect.
The hypothesis is that heated mittens worn at least 15 minutes every day for six weeks has a beneficial effect on physical function in patient with HOA when compared to placebo mittens (heat deactivated).
This study is designed as a randomized controlled trial with two parallel groups (1:1) and physical function of the hand as primary endpoint after six weeks.
The plan is to include 200 patients with HOA for this study. The intervention group will receive mittens with functioning heating elements; the control group will receive mittens without a functioning heating element. All participants are asked to wear the mittens for 6 weeks, 15 minutes each day.
The primary endpoint is change in physical function of the hand, measured with the Australian/Canadian Osteoarthritis Hand Index (AUSCAN).
详细描述
The primary objective of this trial is to assess the efficacy of an intervention with heated mittens in patients with hand osteoarthritis (HOA).
The joints of the hands are some of the most commonly joints affected by osteoarthritis, together with hip and knee joints. Approximately 40% of adults have both self-reported and X-ray conformed signs of HOA. The prevalence increases with age and as the elderly population is growing so will the number of persons with HOA.
HOA is a heterogeneous disease with varying levels of symptoms and joint involvement. The most frequently affected joints are the carpometacarpal (CMC) 1 joints together with the distal interphalangeal (DIP), less frequent the proximal interphalangeal (PIP) joints. The primary symptoms are reduced function, stiffness and pain.
Pharmacological treatments have limited effect. Non-pharmacological treatments (such as exercise) have been investigated in a limited number of studies with overall minimal effect on the primary symptoms. In the earlier days the use of heating interventions, such as paraffin bath, were common treatment for patients with arthritis. During the last decades a shift from heating to exercise oriented treatment have occurred, however seemingly with limited effect on the primary symptoms. American College of Rheumatology (ACR) newest published guideline for the management of HOA (2020) recommend heating as a treatment among others but without scientific sound evidence for effect.
An interview have been conducted at the Parker Institute with people suffering from HOA and all agreed that head was their preferred treatment for symptom reduction. They also stated that heat could reduce stiffness of the fingers. Heating therapy is assumed to provide analgesic effect and decrease muscle tonicity. Two studies have investigated the sort term effect of heat wrap therapy on low back and wrist pain compared to ibuprofen or placebo medication, respectively. In both studies the effect of the heat wrapping therapy was superior to the control group in reducing pain and increasing motion. This suggests that there is a short-term effect of heating therapy in musculoskeletal conditions.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A designated person will number the all mittens using a randomization list. The rest of the study personnel (care provider, investigator, outcome assessor) will thereby not be aware of which mittens that functions and which that do not.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HOA with fulfillment of the ACR criteria:
- •a. Hand pain, aching or stiffness on most days the previous 4 weeks
- •And at least 3 of the following features:
- •Hard tissue enlargement of ≥2 of the 10 selected joints*
- •Hard tissue enlargement of ≥2 of the 10 DIP joints
- •Fewer than 3 swollen metacarpophalangeal (MCP) joints
- •Deformity of at least 1 of 10 selected joints* *The 10 selected joints are the second and third DIP, the second and third PIP, and the first carpometacarpal joints of both hands.
- •AUSCAN Function ≥ 40 aggregated points (0-100 scale)
- •Willing and able to participate in all study visits
- •Able to understand and read Danish.
排除标准
- •Other diseases affecting the joints of the hand (Rheumatoid arthritis, Psoriatic arthritis, ect.)
- •Widespread or generalized pain syndrome (e.g. fibromyalgia)
- •Steroid injections in the finger joints within the last month
- •Other condition that in the opinion of the investigator makes the participant unsuitable for participation.
结局指标
主要结局
Change in hand physical function
时间窗: Baseline, week 6 (end-of-study)
change in physical function is measured with the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). AUSCAN is a validated questionnaire with 3 subscales assessing pain, hand stiffness and hand function during the last 48 hours. Each question is rated on a visual analog scale from 0 (no problems) to 100 (severe problems). The subscale function will be used.
次要结局
- Change in tender and swollen joint count(baseline, week 6)
- Change in global assessment of hand related problems(Baseline, week 6)
- Change in stiffness(Baseline, week 6)
- Change in hand pain(Baseline, week 6)
- Change in grip strength(Baseline, week 6)
研究者
Cecilie Bartholdy
Investigator
Frederiksberg University Hospital