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Trial registered on ANZCTR


Registration number
ACTRN12613000140752
Ethics application status
Approved
Date submitted
4/02/2013
Date registered
6/02/2013
Date last updated
6/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised clinical trial of physiotherapy, therapeutic ultrasound and hand splinting for carpal tunnel syndrome.
Scientific title
Manual therapy and neurodynamic exercises, therapeutic ultrasound and hand splinting in the treatment of carpal tunnel syndrome: A randomised controlled trial.
Secondary ID [1] 281716 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal tunnel syndrome 288013 0
Condition category
Condition code
Musculoskeletal 288389 288389 0 0
Other muscular and skeletal disorders
Neurological 288393 288393 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 288644 288644 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapy treatment: education, manual therapy, and tendon gliding and neurodynamic exercises for the hand and upper limb. Participants will attend 9 sessions over 7 weeks (twice weekly for first 2 weeks and once a week for the following 5 weeks). The duration of each session will be approximately 30 minutes.


Half of the participants in this group will also receive a hand splint (random allocation). The hand splint is worn at night during sleep over the 7weeks treatment period.
Intervention code [1] 286442 0
Rehabilitation
Intervention code [2] 286468 0
Treatment: Devices
Comparator / control treatment
Therapeutic ultrasound treatment (1MHz, pulsed mode, 1 watt/cm2, 15 mins) applied over the carpal tunnel. Participants will attend 20 sessions (10 sessions in the first 2 weeks and twice weekly for the following 5 weeks). The duration of each session will approximately be 20 minutes.

Half of the participants in this group will also receive a hand splint (random allocation). The hand splint is worn at night during sleep over the 7weeks treatment period.

Control group
Active

Outcomes
Primary outcome [1] 288562 0
Global Rating of Change score (GROC) on a 6-point Likert scale (1: Much worse, 2: Worse, 3: No change, 4: Improved, 5: Much improved, 6: Completely recovered).
Timepoint [1] 288562 0
Beseline, 7 weeks post baseline, 12 weeks post baseline and 52 weeks post baseline.
Secondary outcome [1] 300466 0
Scores from Boston Carpal Tunnel Syndrome Questionnaire,
Timepoint [1] 300466 0
Baseline, 7 weeks post baseline, 12 weeks post baseline and 52 weeks post baseline.
Secondary outcome [2] 301021 0
Kamath questionnaire. Assessment of symptom severity in carpal tunnel syndrome.
Timepoint [2] 301021 0
Baseline, 7 weeks post baseline, 12 weeks post baseline and 52 weeks post baseline.
Secondary outcome [3] 301023 0
SF-36 (Short form 36 health survery). Assessment of quality of life.
Timepoint [3] 301023 0
Baseline, 7 weeks post baseline, 12 weeks post baseline and 52 weeks post baseline.
Secondary outcome [4] 301024 0
Hand grip and tip-pinch strength using digital hand dynamometer.
Timepoint [4] 301024 0
Baseline, 7 weeks post baseline, 12 weeks post baseline and 52 weeks post baseline.

Eligibility
Key inclusion criteria
Mild to moderate carpal tunnel syndrome based on clinical criteria combined with electrodiagnostic test findings
Minimum age
18 Years
Maximum age
70 Years
Gender
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 carpal tunnel syndrome
Cervical radiculopathy or other neuropathy of the upper limb/neck
Pregnancy associated carpal tunnel syndrome
Pending litigation
Treatment for carpal tunnel syndrome within 3 months prior to selection

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 opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Queensland clinical trial centre (http://www.sph.uq.edu.au/qctbc)
Simple randomisation using a randomisation table created by computer software. (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Binary logistic or repeated measure ANCOVA for analysis of GROC, questionnaire scores and strength measurement. Baseline measurement as covariates.

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)
QLD

Funding & Sponsors
Funding source category [1] 286506 0
Government body
Name [1] 286506 0
National Health and Medical Research Council (NHMRC)
Address [1] 286506 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286506 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
School of Health and Rehabilitation Sciences
QLD 4072, St Lucia
Australia
Country
Australia
Secondary sponsor category [1] 285294 0
None
Name [1] 285294 0
Address [1] 285294 0
Country [1] 285294 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288582 0
Medical Research Ethics Committee (MREC) of The University of Queensland
Ethics committee address [1] 288582 0
Research Management Office
Cumbrae-Stewart (Building 72)
The University of Queensland
St Lucia, QLD 4072
Ethics committee country [1] 288582 0
Australia
Date submitted for ethics approval [1] 288582 0
18/12/2008
Approval date [1] 288582 0
18/02/2009
Ethics approval number [1] 288582 0
2008000007

Summary
Brief summary
Reviews of the literature show limited evidence for the efficacy of conservative management of patients with carpal tunnel syndrome and a lack of studies investigating the long term effects of the non-surgical management of patients with carpal tunnel syndrome. The aim of our study is to investigate the long-term efficacy of a multimodal approach comprising of manual mobilisation techniques, education and nerve and tendon gliding exercises (MEX) versus therapeutic ultrasound treatment in managing carpal tunnel syndrome. Hand splinting is included as an adjunct intervention to evaluate its influence on the 2 treatment approaches. We hypothesise that the MEX treatment approach would be superior to therapeutic ultrasound treatment in the long-term and the addition of hand splint in either treatment would improve its overall outcome.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 36786 0
A/Prof Michel Coppieters
Address 36786 0
School of Health and Rehabilitation Sciences
The University of Queensland
QLD 4072 St Lucia
Australia
Country 36786 0
Australia
Phone 36786 0
+61 7 3365 1644
Fax 36786 0
+61 7 3365 1622
Email 36786 0
m.coppieters@uq.edu.au
Contact person for public queries
Name 36787 0
A/Prof Michel Coppieters
Address 36787 0
School of Health and Rehabilitation Sciences
The University of Queensland
QLD 4072 St Lucia
Australia
Country 36787 0
Australia
Phone 36787 0
+61 7 3365 1644
Fax 36787 0
+61 7 3365 1622
Email 36787 0
m.coppieters@uq.edu.au
Contact person for scientific queries
Name 36788 0
A/Prof Michel Coppieters
Address 36788 0
School of Health and Rehabilitation Sciences
The University of Queensland
QLD 4072 St Lucia
Australia
Country 36788 0
Australia
Phone 36788 0
+61 7 3365 1644
Fax 36788 0
+61 7 3365 1622
Email 36788 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