Carpal Tunnel SyndromeNCT03582735
Preoperative Neuromobilization Exercises for Individuals With Carpal Tunnel Syndrome
A study testing Nerve gliding exercise in people with Carpal Tunnel Syndrome, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Nerve gliding exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 7 Sep 2015to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EMG confirmed diagnosis of carpal tunnel syndrome
- Listed for carpal tunnel decompression
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de l'Université de Montréal
Montreal, Quebec, H2X 0A9
About this study
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
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
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Nerve gliding exercise
- Keywords
- Carpal Tunnel Syndrome, Ultrasound Imaging, Preoperative Care, Exercise Therapy
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve gliding exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Nerve gliding exercise | Experimental | Three series of 15 daily repetition of the rehabilitation exercise targetting nerve excursion Receives: Other: Nerve gliding exercise |
| Control | No intervention | No intervention according to current practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
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%)
Measured: 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
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%)
Measured: Baseline (T0), one month (T1), and two months (T2) following randomization
Change in pinch grip strength
Assessment of thumb strength (in kilogram) using hand held dynamometer
Measured: Baseline (T0), 4th week (T1), and four weeks following surgery (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2018
- Study start7 Sep 2015
- Primary completion13 Aug 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dany H. Gagnon, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
- Investigators
- Dany H Gagnon, PT, PhD, Principal investigator, Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03582735
- Sponsor's protocol ID
- DG_NM_15e
- Other IDs
- 2015-16-#19
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03582735
- Acronym / sponsor ID
- DG_NM_15e
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Syndrome, Ultrasound Imaging, Preoperative Care, Exercise Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealUniversity, hospital or other
- Study start
- 7 Sep 2015 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 11 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Nerve gliding exercise | Experimental | Other: Nerve gliding exerciseThree series of 15 daily repetition of the rehabilitation exercise targetting nerve excursion |
| Control | No intervention | –No intervention according to current practice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- EMG confirmed diagnosis of carpal tunnel syndrome
- Listed for carpal tunnel decompression
Key exclusion criteria (6 listed)
- Previous trauma or surgery impairing motion of the upper limb
- Diabetes
- Thyroid disease
- Rheumatoid arthritis
- Recent pregnancy (< 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve gliding exerciseA 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. | Other | Nerve gliding exercise |
Primary outcome
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)
Time frame: 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).
Change upper limb functional abilities measured with the Disability of the Arm, Shoulder and Hand (DASH) scale
Time frame: 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).
3 secondary outcomes
Change in median nerve cross sectional area at the carpal tunnel inlet measured by quantitative ultrasound imaging
Time frame: 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
Time frame: Baseline (T0), one month (T1), and two months (T2) following randomization
Change in pinch grip strength
Time frame: Baseline (T0), 4th week (T1), and four weeks following surgery (T2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Individual participant dataSharing planned: Yes. Deidentified participant data that underlie the results submitted for publication in peer-reviewed journal (text, tables, figures, and appendices).
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dany H Gagnon, PT, PhD principal investigator
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve gliding exercise in people with Carpal Tunnel Syndrome, run by Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Baseline (T0), one month (T1), and two months (T2) following randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2019.