Effects of a Preoperative Neuromobilization Program Offered to Individuals With Carpal Tunnel Syndrome Awaiting Carpal Tunnel Release Surgery: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change upper limb functional abilities measured with the Disability of the Arm, Shoulder and Hand (DASH) scale
研究概览
简要总结
Carpal tunnel syndrome is one of the major known disorders of the wrist and hand that causes pain, tingling sensations, weakness of the hand and functional limitations in daily tasks (for example: handling objects with the hands). In the early stages of the syndrome, some individuals may benefit from wearing wrist splint or cortisone infiltration. For those with ongoing symptoms, surgery is often indicated. However, some individuals may experience worsening of their condition while waiting for surgery. To aid those individuals, physiotherapists often recommend exercises that aim to "glide" the nerve inside the arm. Specifically, these exercises involve arm and neck movements in a specific order, with the aim of improving the motion of the median nerve in relation with its environment. These nerve gliding exercises may have a favorable effect on the median nerve and may improve pain and upper limb functional abilities. In this study, the investigators aim to evaluated the feasibility and effects of a preoperative nerve gliding exercises completed by individuals undergoing surgery
详细描述
Carpal Tunnel Syndrome (CTS) is a common disorder characterized by alterations of the median nerve integrity at the carpal tunnel. The syndrome is classically recognized by chief complains of nocturnal or intermittent pain and paresthesia involving the median nerve sensory territory of the hand. In more severe condition, worsening of pain and paresthesia as well as thenar muscle atrophy may be present and lead to disability.
Many conservative treatments for CTS are available. Yet, the current literature only support the use of wrist splints and cortisone infiltration, which have been shown to provide only temporary relief for many individuals. Those with ongoing symptoms or severe conditions are often offered carpal tunnel decompression surgery. However, the costs related to the surgery and the increasing delays on waiting lists warrants the need for better conservative management. A preoperative rehabilitation exercise program based on nerve gliding exercise is advocated by physical therapists to manage physical impairments and functional limitations associated with CTS. These exercises can be implement at low cost in the setting of an home-based program.
The investigators aim to examine the feasibility and the efficacy of a preoperative home rehabilitation program based on nerve gliding exercises completed by individuals with carpal tunnel Syndrome waiting for decompression surgery.
In this trial, individuals awaiting carpal tunnel decompression surgery will be randomly allocated to either complete a preoperative nerve-gliding exercise program (experimental group) or no intervention (control group). Thirty participants confirmed with CTS by their attending hand surgeons and enlisted for carpal tunnel decompression will be recruited for this study conducted at the hospital of the Université de Montréal (CHUM), Montreal, Quebec, Canada. All individuals enrolled in the study will be prioritized on the surgical waiting list to receive their surgery five weeks after initiating the study in order to ensure consistency between different timeframes of the study.
The effects of the nerve-gliding exercise program will be assessed at baseline (T0) using standardized questionnaires, quantitative ultrasound measurements (including static and dynamic evaluations) of the median nerve, pinch grip strength and will be repeated after four weeks (T1; preoperative period) and four weeks following surgery (T2; postoperative period).
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
Outcome assessors will be blind to participant allocation
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EMG confirmed diagnosis of carpal tunnel syndrome
- •Listed for carpal tunnel decompression
排除标准
- •Previous trauma or surgery impairing motion of the upper limb
- •Thyroid disease
- •Rheumatoid arthritis
- •Recent pregnancy (< 3 months)
- •Unable to communicate in English or French
结局指标
主要结局
Change upper limb functional abilities measured with the Disability of the Arm, Shoulder and Hand (DASH) scale
时间窗: Baseline (T0), one month (T1), and two months (T2) following randomization
The DASH includes 30 questions covering participation and performance of daily activities with the upper limb as well as symptom severity in individuals with musculoskeletal upper limb disorder. Each question is rated on a Likert scale ranging from 1 to 5, where a higher weighted score (range 0-100) represents substantial functional limitations. The French version of the DASH has been adapted and validated and has demonstrated excellent repeatability (ICC = 0.91) when tested in adults with chronic musculoskeletal pain (Hudak, Amadio, and Bombardier 1996, Durand et al. 2005). The normalized MDC was established (MDC90% = 10.7%) (Greenslade et al. 2004).
Change in different pain-related disabilities and cognitive-behavioral factors involved in the experience of pain measured by the West Haven-Yale Multidimensional Pain inventory (WHYMPI)
时间窗: Baseline (T0), one month (T1), and two months (T2) following randomization
The WHYMPI is comprised of 52 questions organized into subscales quantifying domains including two subscales specific to pain experience (i.e., pain interference (9 items), and pain severity (3 items)). Each question is rated on a Likert scale ranging from 0 to 6 and a mean score is computed for each subscale. A higher mean score represents higher disability (e.g., very intense pain or extreme interference). The French version of the WHYPMI has been adapted and validated and has demonstrated good repeatability (ICC \> 0.75) when tested in adults with chronic musculoskeletal pain (Laliberté et al. 2008, Kerns, Turk, and Rudy 1985). The normalized minimal detectable change (MDC) for the WHYMPI for each of the five WHYMPI subscales range from MDC90%=15.4% (pain interference) to MDC90%=22.8% (emotional distress) (Bergström et al. 1999).
次要结局
- Change in median nerve longitudinal excursion at the distal forearm measured by quantitative ultrasound imaging(Baseline (T0), one month (T1), and two months (T2) following randomization)
- Change in pinch grip strength(Baseline (T0), 4th week (T1), and four weeks following surgery (T2))
- Change in median nerve cross sectional area at the carpal tunnel inlet measured by quantitative ultrasound imaging(Baseline (T0), one month (T1), and two months (T2) following randomization)
研究者
Dany H. Gagnon
Senior researcher
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal