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Trial registered on ANZCTR


Registration number
ACTRN12611000690954
Ethics application status
Approved
Date submitted
13/03/2009
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
the effect of splinting and exercises on swelling of the nerve in patients with carpal tunnel syndrome
Scientific title
The effect of nerve and tendon gliding exercises and splinting on median nerve oedema in patients with carpal tunnel syndrome
Secondary ID [1] 829 0
NA
Universal Trial Number (UTN)
Trial acronym
NA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
carpal tunnel syndrome 4473 0
Condition category
Condition code
Musculoskeletal 268384 268384 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patietns are randomly allocated to one of two interventional groups:

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.

splinting: patients are wearing a wrist splint at night for one week.
Intervention code [1] 4216 0
Treatment: Other
Intervention code [2] 266920 0
Treatment: Devices
Comparator / control treatment
no treatment
Control group
Active

Outcomes
Primary outcome [1] 5612 0
median nerve signal intensity and carpal ligament bowing will be evaluated on magnetic resonance images (MRI) of the patients' wrists.
Timepoint [1] 5612 0
baseline, immediately after one session of nerve and tendon gliding exercises or splinting (10minutes) and 1 week after baseline.
Secondary outcome [1] 9443 0
hand symptoms assessed using the Boston Carpal tunnel questionnaire, the s-LANSS scale (Leeds Assessment of neuropathic symptoms and signs), visual analogue scales for pain and numbness as well as the global rating of change scale.
Timepoint [1] 9443 0
baseline, immediately after one session of nerve and tendon gliding exercises or splinting (10minutes) and 1 week after baseline.
Secondary outcome [2] 279045 0
hand function assessed using the Boston Carpal tunnel questionnaire and the patient specific functional scale
Timepoint [2] 279045 0
baseline, immediately after one session of nerve and tendon gliding exercises or splinting (10minutes) and 1 week after baseline.

Eligibility
Key inclusion criteria
carpal tunnel syndrome
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Systemic inflammatory diseases
Diabetes mellitus
Metal implants
Previous wrist surgery or wrist fracture
Traumatic onset of CTS
Cervical radiculopathy or other neuropathy of the upper limb/neck
Pregnancy associated CTS (or thought to be pregnant as MRI is a relative contraindication)
Pending litigation
Claustrophobia (MRI)

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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1544 0
4066
Recruitment postcode(s) [2] 4223 0
4102
Recruitment postcode(s) [3] 4224 0
4072

Funding & Sponsors
Funding source category [1] 267392 0
Government body
Name [1] 267392 0
Queensland Health Practicioner Research Scheme
Address [1] 267392 0
Allied Health Clinical Education and Training Unit
Level 3
Forestry House
160 Mary Street
Brisbane QLD 4000
Country [1] 267392 0
Australia
Funding source category [2] 267394 0
Government body
Name [2] 267394 0
National Health and Medical Research Council
Address [2] 267394 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [2] 267394 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] 266452 0
None
Name [1] 266452 0
Address [1] 266452 0
Country [1] 266452 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6699 0
Human Research Ethics Committee The University of Queensland
Ethics committee address [1] 6699 0
St Lucia
QLD 4072
Ethics committee country [1] 6699 0
Australia
Date submitted for ethics approval [1] 6699 0
06/02/2009
Approval date [1] 6699 0
11/03/2009
Ethics approval number [1] 6699 0
2009000184
Ethics committee name [2] 269365 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [2] 269365 0
Princess Alexandra Hospital
Ipswich Road
Woolloongabba QLD 4102
Ethics committee country [2] 269365 0
Australia
Date submitted for ethics approval [2] 269365 0
16/03/2009
Approval date [2] 269365 0
24/06/2009
Ethics approval number [2] 269365 0
2009/078

Summary
Brief summary
This study will investigate whether nerve and tendon gliding exercises or splinting are capable of reducing swelling intra- as well as extraneurally in patients with carpal tunnel syndrome.
Trial website
NA
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 29394 0
Address 29394 0
Country 29394 0
Phone 29394 0
Fax 29394 0
Email 29394 0
Contact person for public queries
Name 12641 0
Michel Coppieters
Address 12641 0
The University of Queensland
School of Health and Rehabilitation Sciences
QLD 4072 St Lucia
Country 12641 0
Australia
Phone 12641 0
+61 7 3365 1644
Fax 12641 0
Email 12641 0
m.coppieters@uq.edu.au
Contact person for scientific queries
Name 3569 0
Michel Coppieters
Address 3569 0
The University of Queensland
School of Health and Rehabilitation Sciences
QLD 4072 St Lucia
Country 3569 0
Australia
Phone 3569 0
+61 7 3365 1644
Fax 3569 0
Email 3569 0
m.coppieters@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary