Clinical trial NCT03582735: Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome
Official title: Effects of a Preoperative Neuromobilization Program Offered to Individuals With Carpal Tunnel Syndrome Awaiting Carpal Tunnel Release Surgery: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Ultrasound Imaging
Preoperative Care
Exercise Therapy
Lead sponsor: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be allocated in two groups to receive either the experimental intervention (i.e., nerve gliding exercise program) or control intervention (i.e., no treatment)
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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).

Feasibility metrics will be analyzed using descriptive statistics. A significant interaction between the group allocation (experimental vs. control) and time (T0 vs. T1 vs. T2) on the main outcomes will be evaluated using two-way mixed ANOVAs.

Eligibility criteria: Inclusion Criteria:

* EMG confirmed diagnosis of carpal tunnel syndrome
* Listed for carpal tunnel decompression

Exclusion Criteria:

* Previous trauma or surgery impairing motion of the upper limb
* Diabetes
* Thyroid disease
* Rheumatoid arthritis
* Recent pregnancy (\< 3 months)
* Unable to communicate in English or French

Primary outcomes:
measure: 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)
timeFrame: Baseline (T0), one month (T1), and two months (T2) following randomization
measure: Change upper limb functional abilities measured with the Disability of the Arm, Shoulder and Hand (DASH) scale
timeFrame: Baseline (T0), one month (T1), and two months (T2) following randomization
Secondary outcomes:
measure: Change in median nerve cross sectional area at the carpal tunnel inlet measured by quantitative ultrasound imaging
timeFrame: Baseline (T0), one month (T1), and two months (T2) following randomization
measure: Change in median nerve longitudinal excursion at the distal forearm measured by quantitative ultrasound imaging
timeFrame: Baseline (T0), one month (T1), and two months (T2) following randomization
measure: Change in pinch grip strength
timeFrame: Baseline (T0), 4th week (T1), and four weeks following surgery (T2)
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire de l'Université de Montréal
state: Quebec
Study officials:
affiliation: Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
name: Dany H Gagnon, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: