Web-based Rehabilitation After Surgical Salvage Procedures for Wrist Osteoarthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- Patient Rated Wrist Evaluation (PRWE) score, 3 months after cast removal compared to baseline.
研究概览
简要总结
Wrist osteoarthritis is often caused by past trauma to the wrist. The primary symptom is joint pain. Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain.
This trial aims to evaluate if a web-based rehabilitation protocol is non-inferior to standard, face-to-face, rehabilitation in terms of patient-reported outcome after surgical salvage procedures.
详细描述
Osteoarthritis (OA) is a chronic disease which affects all tissues of the joint - cartilage, ligaments, synovial membrane, tendons, and bone. The primary symptom is joint pain but other symptoms like swelling, stiffness, crepitus, and joint instability may also be present.
OA is most in common in knee, hip, and hand but all joints can be affected. It is estimated that nearly 50% of women and 25% of men risk hand OA during their lifetime. Interphalangeal joints and thumb base are the primarily affected joints in the hand while the wrist is less common. Wrist OA is, in contrary to interphalangeal joints and thumb base, more common in men than in women and at a younger age.
Wrist OA is often caused by past trauma to the wrist e.g., fractures, dislocations, and ligament injuries. However, avascular necrosis i.e., Mb Kienböck and Mb Preiser, and other medical conditions may also lead to wrist OA.
Although there is no cure, patients with hip and knee OA, may benefit from self-management treatment options. For hand and wrist OA, the effects of exercise therapy are less studied. A Cochrane review found low-quality evidence of small positive effects of exercise on pain, function, and finger joint stiffness. In wrist OA, a recent randomized controlled trial reported that neuromuscular joint-protective exercise therapy was not superior to range of motion exercises in reducing pain and improving function.
Salvage surgery is the final solution if exercise therapy, analgesics, orthoses, or cortisone injections fail to relieve pain. Numerous studies describe different types of surgical salvage procedures in wrist OA but, to our knowledge, none compare different types of rehabilitation after surgery.
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)
盲法说明
Data analyst
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
- •Planned surgery:
- •Four corner fusion (4CF)
- •Lunate-Capitate fusion (LCF)
- •Scaphoid-Trapezium-Trapezoid fusion (STT)
- •Radius-Scaphoid-Lunate fusion (RSL)
- •Proximal Row Carpectomy (PRC)
- •Access to digital identification.
排除标准
- •Unstable rheumatoid arthritis or other chronic inflammatory arthritis. However, stable inflammatory arthritis with unchanged medication during the last 12 weeks is not an exclusion criteria.
- •History of psoriasis arthritis, gout, or pseudogout affecting the hand or wrist.
- •Symptomatic OA in nearby joints.
- •Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction, inability to use web-based tools).
研究组 & 干预措施
Web-based rehabilitation
The web-based platform contains text, images, and videos which will educate and inform the patient regarding the operation and rehabilitation.
There will be no scheduled physical consultations, however participants may request additional video consultations and can send text messages to the hand therapist.
干预措施: Web-based rehabilitation (Other)
Standard rehabilitation
The control group receive the same education and exercises. The information is provided verbally and a booklet with images of the exercises is given. However, they do not get access to the web-based platform and follow-up appointments are face-to-face at the clinic.
At the follow-up appointments, participants perform their exercises, and adjustments and corrections are made when needed.
干预措施: Standard rehabilitation (Other)
结局指标
主要结局
Patient Rated Wrist Evaluation (PRWE) score, 3 months after cast removal compared to baseline.
时间窗: From enrollment to the end of treatment at 3 months after cast removal.
Patient Rated Wrist Evaluation (PRWE) score (0-100 points). A higher score indicates a worse outcome.
次要结局
- Differences in direct costs - between groups.(From enrollment to the end of treatment at 3 months after cast removal.)
- Pain at rest and on load - change in score from baseline to cast removal and 3 months after cast removal.(From enrollment to the end of treatment at 3 months after cast removal.)
- Quality of life (EQ-5D-5L) - change in score from baseline to cast removal and 3 months after cast removal.(From enrollment to the end of treatment at 3 months after cast removal.)
- Pain catastrophizing scale - change in score from baseline to cast removal and 3 months after cast removal.(From enrollment to the end of treatment at 3 months after cast removal.)
- Tampa Scale of Kinesiophobia - change in score from baseline to cast removal and 3 months after cast removal.(From enrollment to the end of treatment at 3 months after cast removal.)
- Range of motion - change from baseline to cast removal and 3 months after cast removal.(From enrollment to the end of treatment at 3 months after cast removal.)
- Grip strength - change in score from baseline to 3 months after cast removal.(From enrollment to the end of treatment at 3 months after cast removal.)
- Patient Reported Experience Measures (PREM).(3 months after cast removal.)
- Adherence to excercise program.(From enrollment to the end of treatment at 3 months after cast removal.)
- Complications - number of participants.(From enrollment to the end of treatment at 3 months after cast removal.)
- Length of sick leave, ability to return to previous work.(From enrollment to the end of treatment at 3 months after cast removal.)
- Number of consultations.(From enrollment to the end of treatment at 3 months after cast removal.)
研究者
Elin Swärd
Principal Investigator, MD, PhD
Karolinska Institutet
