Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000691943
Ethics application status
Approved
Date submitted
7/07/2011
Date registered
7/07/2011
Date last updated
10/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of nerve and tendon gliding exercises on pressure in the wrist in patients with carpal tunnel syndrome
Scientific title
The effect of nerve and tendon gliding exercises on carpal tunnel pressure in patients with carpal tunnel syndrome
Secondary ID [1] 262586 0
NA
Universal Trial Number (UTN)
NA
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 268254 0
Condition category
Condition code
Musculoskeletal 268387 268387 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
nerve and tendon gliding exercises:
Ten repetitions of six different exercises are
performed per session. One session takes
approximately 2 minutes to complete. Participants
are asked to complete 10 sessions per day for
one week.
Intervention code [1] 266918 0
Treatment: Other
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 269153 0
carpal tunnel pressure will be evaluated in various wrist positions and during two computer tasks (typing and a mouse task).
Carpal tunnel pressure is measured via insertion of an epidural cathether connected to a pressure transducer.
Timepoint [1] 269153 0
baseline, immediately after 1 session of nerve and tendon gliding exercises (10 minutes) and 1 week after baseline
Secondary outcome [1] 279041 0
Hand symptoms assessed with the Boston carpal tunnel questionnaire, the s-LANSS (Leeds Assessment of Neuropathic Symptoms and Sign) scale, visual analogue scale of pain, numbness and tingling as well as the global rating of change scale.
Timepoint [1] 279041 0
baseline and 1 week after baseline

Eligibility
Key inclusion criteria
mild to moderate carpal tunnel syndrome
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
severe carpal tunnel syndrome
Systemic inflammatory diseases
Diabetes mellitus
Previous surgery or trauma to the upper limb or neck
Traumatic onset of CTS
Cervical radiculopathy or other neuropathy of the
upper limb/neck
Pregnancy associated CTS
Pending litigation
treatment for carpal tunnel syndrome within the last 3 months prior to testing.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
concealed allocation with sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using the research randomiser software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2010
Actual
1/06/2010
Date of last participant enrolment
Anticipated
31/05/2011
Actual
31/05/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267395 0
Government body
Name [1] 267395 0
National Health and Medical Research Council
Country [1] 267395 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
School of Health and Rehabilitation Sciences
QLD 4072, St Lucia
Country
Australia
Secondary sponsor category [1] 266454 0
None
Name [1] 266454 0
Address [1] 266454 0
Country [1] 266454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269366 0
Human Research Ethics Committee The University of Queensland
Ethics committee address [1] 269366 0
St Lucia
QLD 4072
Ethics committee country [1] 269366 0
Australia
Date submitted for ethics approval [1] 269366 0
10/02/2009
Approval date [1] 269366 0
11/03/2009
Ethics approval number [1] 269366 0
2009000161

Summary
Brief summary
This study will investigate whether nerve and tendon gliding exercises are capable of reducing carpal tunnel pressure in patients with carpal tunnel syndrome
Trial website
NA
Trial related presentations / publications
Schmid AB, Elliott JM, Strudwick MW, Little M, Coppieters MW. Effect of Splinting and Exercise on Intraneural Edema of the Median Nerve in Carpal Tunnel Syndrome—An MRI Study to Reveal Therapeutic Mechanisms. Journal of Orthopaedic Research. 2012 Aug; 30(8). pp. 1343-50.).
Public notes

Contacts
Principal investigator
Name 32845 0
A/Prof Michel Coppieters
Address 32845 0
SHRS, the University of Queensland, Therapies Buliding 84A, St Lucia QLD 4072
Country 32845 0
Australia
Phone 32845 0
+61 7 3365 1644
Fax 32845 0
Email 32845 0
[email protected]
Contact person for public queries
Name 16092 0
A/Prof Michel Coppieters
Address 16092 0
The University of Queensland
School of Health and Rehabilitation Sciences
QLD 4072 St Lucia
Country 16092 0
Australia
Phone 16092 0
+61 7 3365 1644
Fax 16092 0
Email 16092 0
[email protected]
Contact person for scientific queries
Name 7020 0
A/Prof Michel Coppieters
Address 7020 0
The University of Queensland
School of Health and Rehabilitation Sciences
QLD 4072 St Lucia
Country 7020 0
Australia
Phone 7020 0
+61 7 3365 1644
Fax 7020 0
Email 7020 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.