Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome

NCT03582735 | Completed DMC

• 2 other identifiers: DG_NM_15e2015-16-#19
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Ultrasound Imaging; Preoperative Care; Exercise Therapy

Outcome Measures

Primary Outcomes (2)

• 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)

  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).

  Baseline (T0), one month (T1), and two months (T2) following randomization

• Change upper limb functional abilities measured with the Disability of the Arm, Shoulder and Hand (DASH) scale

  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).

  Baseline (T0), one month (T1), and two months (T2) following randomization

Secondary Outcomes (3)

• 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

• 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)

Study Arms (2)

Nerve gliding exercise

EXPERIMENTAL

Three series of 15 daily repetition of the rehabilitation exercise targetting nerve excursion

Other: Nerve gliding exercise

Control

NO INTERVENTION

No intervention according to current practice.

Interventions

Nerve gliding exercise OTHER

A 4-week home-based nerve-gliding exercise program (NGEP) including isolated and coupled upper limb and neck movements. A specific mobilization was elaborated for each week of the program allowing to gradually increase the range of movement and inter-articular coordination.

Nerve gliding exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal: lead

Study Sites (1)

Centre Hospitalier Universitaire de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Dany H Gagnon, PT, PhD

  Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to participant allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior researcher

Model Details: 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)

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 11, 2018
• Study Start: September 7, 2015
• Primary Completion: August 13, 2018
• Study Completion: September 30, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement

Locations

CA (1)