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Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nerve gliding exercise
Sponsored by
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Ultrasound Imaging, Preoperative Care, Exercise Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de l'Université de Montréal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nerve gliding exercise

Control

Arm Description

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

No intervention according to current practice.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

Change in median nerve cross sectional area at the carpal tunnel inlet measured by quantitative ultrasound imaging
Static images of the median nerve's are acquired in the transverse plane at the level of the carpal tunnel inlet. The cross-sectional area of the median nerve is defined by semi-automatically outlining the inner border of the epineurium and will be assess offline using custom software. Median nerve cross-sectional area measurement has good repeatability ( > 0.88) when performed in asymptomatic adults. The normalized MDC was previously estimated for the cross-sectional area measurement (MDC90% = 6.2%)
Change in median nerve longitudinal excursion at the distal forearm measured by quantitative ultrasound imaging
Cineloops of the median nerve are acquired during passive extension of the wrist using ultrasound imaging at the distal forearm. Three region of interest within the epineurium border are manually drawn and will be assess offline custom software. Median nerve longitudinal excursion has good repeatability ( > 0.84) when performed in a mixed population including asymptomatic individuals and individuals with carpal tunnel syndrome. The normalized MDC was previously estimated for the longitudinal excursion measurement (MDC90% = 34.1%)
Change in pinch grip strength
Assessment of thumb strength (in kilogram) using hand held dynamometer

Full Information

First Posted
June 28, 2018
Last Updated
January 29, 2019
Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
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1. Study Identification

Unique Protocol Identification Number
NCT03582735
Brief Title
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

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 7, 2015 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Ultrasound Imaging, Preoperative Care, Exercise Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blind to participant allocation
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nerve gliding exercise
Arm Type
Experimental
Arm Description
Three series of 15 daily repetition of the rehabilitation exercise targetting nerve excursion
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention according to current practice.
Intervention Type
Other
Intervention Name(s)
Nerve gliding exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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).
Time Frame
Baseline (T0), one month (T1), and two months (T2) following randomization
Title
Change upper limb functional abilities measured with the Disability of the Arm, Shoulder and Hand (DASH) scale
Description
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).
Time Frame
Baseline (T0), one month (T1), and two months (T2) following randomization
Secondary Outcome Measure Information:
Title
Change in median nerve cross sectional area at the carpal tunnel inlet measured by quantitative ultrasound imaging
Description
Static images of the median nerve's are acquired in the transverse plane at the level of the carpal tunnel inlet. The cross-sectional area of the median nerve is defined by semi-automatically outlining the inner border of the epineurium and will be assess offline using custom software. Median nerve cross-sectional area measurement has good repeatability ( > 0.88) when performed in asymptomatic adults. The normalized MDC was previously estimated for the cross-sectional area measurement (MDC90% = 6.2%)
Time Frame
Baseline (T0), one month (T1), and two months (T2) following randomization
Title
Change in median nerve longitudinal excursion at the distal forearm measured by quantitative ultrasound imaging
Description
Cineloops of the median nerve are acquired during passive extension of the wrist using ultrasound imaging at the distal forearm. Three region of interest within the epineurium border are manually drawn and will be assess offline custom software. Median nerve longitudinal excursion has good repeatability ( > 0.84) when performed in a mixed population including asymptomatic individuals and individuals with carpal tunnel syndrome. The normalized MDC was previously estimated for the longitudinal excursion measurement (MDC90% = 34.1%)
Time Frame
Baseline (T0), one month (T1), and two months (T2) following randomization
Title
Change in pinch grip strength
Description
Assessment of thumb strength (in kilogram) using hand held dynamometer
Time Frame
Baseline (T0), 4th week (T1), and four weeks following surgery (T2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dany H Gagnon, PT, PhD
Organizational Affiliation
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de l'Université de Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 0A9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement
IPD Sharing URL
http://crir.ca

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Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome

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