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Trial registered on ANZCTR


Registration number
ACTRN12613001095752
Ethics application status
Not yet submitted
Date submitted
15/07/2013
Date registered
30/09/2013
Date last updated
30/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a Hand Therapy Preoperative Screening and Intervention Clinic on patient and hospital outcomes : a randomised control trial
Scientific title
The effect of a Preoperative Screening and Intervention Clinic for Carpal Tunnel Syndrome on patient and hospital outcomes : a randomised control trial.
Secondary ID [1] 282814 0
nil
Universal Trial Number (UTN)
U1111-1145-6332
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carpal Tunnel Syndrome 289589 0
Condition category
Condition code
Physical Medicine / Rehabilitation 289926 289926 0 0
Occupational therapy
Physical Medicine / Rehabilitation 289927 289927 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will attend a clinical assessment with a member of the hand therapy unit team who has undergone management of CTS competency training, and assessor training.

This will involve an initial assessment and completion of outcome measures. .

At this time, eligible participants will be randomly allocated (concealed allocation) to either 'standard care' or the 'enhanced care' group.

Enhanced care:

Participants will attend a group one off education class that will cover general information on CTS, education regarding posture and activity modification, provision of wrist splints for night-time use, active range of motion exercises and neural glides for the median nerve. This class will run for approx 30mins.

Participants will follow this conservative, home-based intervention programme for 6 weeks, at which time they will attend a follow-up consultation with a therapist.

At this appointment, outcome measures will be collected by a trained assessor who has been blinded to group allocation. Based on specific criteria (response to conservative management, clinically relevant change in symptoms based on the Boston CTS Questionnaire and other outcome measures including patients preference) , the therapist will provide this information to the orthopaedic surgeon during a case conference to assist with determining the need for surgery, further monitoring or investigations.

At 6 months post commencing conservative management, a final assessment will be completed using the previous outcome measures.

If the patient has had a reduction in symptoms (as determined by outcome measures), and does not wish to be considered for surgery, than the patient may be discharged into the care of their GP (with a standardised letter) following a case consultation with the orthopaedic surgeon.

If the participant is deemed to have failed conservative management, then they will be reviewed by the orthopaedic surgeon to determine the need for surgery.
Intervention code [1] 287498 0
Rehabilitation
Comparator / control treatment
Standard Care:

This group will continue on the orthopaedic wait-list for appointment with a doctor as per currently implemented strategy for CTS at QEII Hospital for the duration of the 6 month study.

Progress will be monitored using the same patient outcome measures as the enhanced care group at 6 weeks and 6 months post the initial assessment.

At 6 months post commencing the trial, a final assessment will be completed using the previous outcome measures.

At this time, following outcome assessment, they will be offered the option of attending the one off education class (as described in the enhanced care section).

At 6 months, if the patient has had a reduction in symptoms (as determined by outcome measures), and does not wish to be considered for surgery, than the patient may be discharged into the care of their GP (with a standardised letter) following a case consultation with the orthopaedic surgeon.

If the participant is deemed to have failed conservative management, then they will be reviewed by the orthopaedic surgeon to determine the need for surgery.



Control group
Active

Outcomes
Primary outcome [1] 289985 0
Participant Global Rating of Change assessment
Timepoint [1] 289985 0
At 6 weeks and 6 months.
Primary outcome [2] 289986 0
Patient satisfaction with the treatment/management process
Timepoint [2] 289986 0
6 weeks and 6 months post initial appointment
Primary outcome [3] 290624 0
Conversion to surgery rate – comparison between the number of patients requiring surgery in both groups.
Timepoint [3] 290624 0
6 months
Secondary outcome [1] 303718 0
Boston Carpal Tunnel Syndrome Questionnaire
Timepoint [1] 303718 0
Initial appointment, 6 weeks and 6 months
Secondary outcome [2] 303743 0
Participant completed hand diagram which represents symptom distribution.
Timepoint [2] 303743 0
Initial appointment, 6 weeks and 6 months.
Secondary outcome [3] 303744 0
The Patient Specific Functional Scale
Timepoint [3] 303744 0
initial appointment, 6 weeks and 6 months.
Secondary outcome [4] 303745 0
Leeds Assessment of Neuropathic Symptoms and Signs (LANSS)
Timepoint [4] 303745 0
Initial appointment, 6 weeks and 6 months
Secondary outcome [5] 303746 0
Disability of the Hand and Arm (DASH)
Timepoint [5] 303746 0
initial appointment, 6 weeks and 6 months.
Secondary outcome [6] 304925 0
Cost of conservative vs. orthopaedic consultation and surgical management (based on QEII HIMS reports)
Timepoint [6] 304925 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria:

A diagnosis of idiopathic Carpal Tunnel Syndrome confirmed by a nerve conduction study.

3 months or less since referral to the QEII Hospital from their GP.

Symptoms for greater than 2 months

A diagnosis of CTS as determined a nerve conduction study

18-85 years of age
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria:

Diabetes

Patients with severe CTS symptoms as determined by patient outcome measures, nerve conduction resultsand
wasting of the thenar eminence.

Pregnancy related CTS

Inflammatory disease (such as rheumatoid arthritis, lupus)

Wrist and carpal osteoarthritis

Traumatic onset of CTS from a fracture or injury

Pending litigation or WorkCover claim

Other neuropathy of the upper limb.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
It is planned that over a period of 6 months, 120 patients with carpal tunnel syndrome referred to the QEII Orthopaedic Department will be included in the study.

It is has been estimated that a sample of 60 would have sufficient power to detect a one point improvement in the Boston Carpal Tunnel Scale. However, the predicted sample size has been inflated to 120 to increase precision for outcomes and to allow for a maximum drop out rate of 15%.

The number of participants were determined using sample size calculations based on the outcomes of similar studies included in the references.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/10/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1568 0
Queen Elizabeth II Jubilee Hospital - Coopers Plains

Funding & Sponsors
Funding source category [1] 287597 0
Government body
Name [1] 287597 0
Queensland Health - Health Practitioners Research Grant Scheme
Country [1] 287597 0
Australia
Primary sponsor type
Hospital
Name
QEII Jubilee Hospital
Address
QEII Jubilee Hospital
Locked bag 2
Archerfield,
Queensland.
4108
Country
Australia
Secondary sponsor category [1] 286346 0
University
Name [1] 286346 0
University of Queensland
Address [1] 286346 0
School of Health and Rehabilitation Sciences
St Lucia,
Queensland
4067
Country [1] 286346 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289573 0
Metro South's Human Research Ethics and Research Governance
Ethics committee address [1] 289573 0
Princess Alexandra Hospital
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Australia
Ethics committee country [1] 289573 0
Australia
Date submitted for ethics approval [1] 289573 0
18/07/2013
Approval date [1] 289573 0
Ethics approval number [1] 289573 0

Summary
Brief summary
Carpal Tunnel Syndrome (CTS) is the most common condition affecting the upper limb and is associated with significant socioeconomic and quality of life costs.

CTS is either treated conservatively (provision of wrists splints and exercises) or with surgery. However, long public health orthopedic waiting lists often mean symptoms have progressed beyond the point of conservative management being an option.

The aim of this project is to implement a therapy based, screening and early intervention clinic for patients with CTS, to determine its effect on waiting lists, benefits to Hospital based health services and patient satisfaction and clinical outcomes.

The participant group will be those who have been referred to QEII Hospital Orthopedic dept by their General Practitioner for management of CTS.

The method will involve a standard care group who will receive the currently implemented management (i.e. staying on the orthopedic department waitlist for review), and the enhanced care group who will receive early intervention and conservative management. The standard care group will receive treatment at the conclusion of the study, which will still be sooner than they would otherwise normally receive it.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41362 0
Miss Karina Lewis
Address 41362 0
Occupational Therapy Dept
QEII Hospital
Locked Bag 2,
Archerfield
Queensland
4108
Country 41362 0
Australia
Phone 41362 0
+61 7 3176 6331
Fax 41362 0
Email 41362 0
karina_lewis@health.qld.gov.au
Contact person for public queries
Name 41363 0
Mr Leo Ross
Address 41363 0
Occupational Therapy Dept
QEII Hospital
Locked Bag 2,
Archerfield
Queensland
4108
Country 41363 0
Australia
Phone 41363 0
+61 7 3176 6331
Fax 41363 0
Email 41363 0
leo_ross@health.qld.gov.au
Contact person for scientific queries
Name 41364 0
Mr Leo Ross
Address 41364 0
Occupational Therapy Dept
QEII Hospital
Locked Bag 2,
Archerfield
Queensland
4108
Country 41364 0
Australia
Phone 41364 0
+61 7 3176 6111
Fax 41364 0
Email 41364 0
leo_ross@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23279Study protocol-999999  

Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEducation, night splinting and exercise versus usual care on recovery and conversion to surgery for people awaiting carpal tunnel surgery: A protocol for a randomised controlled trial.2016https://dx.doi.org/10.1136/bmjopen-2016-012053
N.B. These documents automatically identified may not have been verified by the study sponsor.