Osteoarthritis Thumb Therapy trial: a randomised controlled trial into the effectiveness and efficacy of splints in thumb base osteoarthritis

niversity of Southampton0 个研究点目标入组 349 人开始时间: 2016年9月26日最近更新: 2021年1月5日

试验速览

•1. Males and females aged 30 years and over
•2. At least moderate AUSCAN hand pain (AUSCAN Hand pain score >5) and functional hand disability
•(AUSCAN hand functional disability score >9)
•3. One of the following:
•3.1. Hard tissue enlargement of the first carpometacarpal joint (CMCJ)
•3.2. Squaring of the thumb base
•3.3. Pain that worsens when pinching
•3.4 Pain that worsens on span grip (eg opening a jar)
•3.5. Crepitus on movement
•3.6. Reduction in thumb base range of movement
•3.7. Positive thumb adduction provocation test
•3.8. Positive thumb extension provocation test
•3.9. Pain on palpation of the dorso-radial aspect of the thumb CMCJ
•4. No other household member participating in the trial
•5. Able to give written informed consent
•6. Available to attend Occupational Therapy/Physiotherapy/Hand Therapy sessions

•1. Consultation with therapy department or treatment for this thumb problem (excluding pain killers and anti-inflammatories) in the previous 6 months
•2. Intra-articular joint injection to wrist, fingers or thumb in the previous 2 months
•3. Fractures or significant injury or surgery to the wrist or hand within the previous 6 months
•4. Red flags e.g. history of serious illness or disease (e.g. rheumatoid arthritis, psoriatic arthritis), progressive neurological signs, acute swollen joint
•5. Diagnosis of dementia or significant disorder likely to affect communication
•6. Already received thumb splints for thumb base OA
•7. Skin disease that may interfere or contraindicate splint wear
•8. Participants of a drug or medical device trial in the last 12 weeks

发起方

niversity of Southampton