Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001234808
Ethics application status
Approved
Date submitted
2/07/2009
Date registered
22/11/2012
Date last updated
21/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Conservative management for wrist pain caused by ulnocarpal abutment (Pilot)
Scientific title
Assessing the effects of a 12 week program of splinting and activity modification on self-assessed wrist and hand pain in people with ulnar sided wrist pain as result of ulno-carpal abutment
Secondary ID [1] 273216 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wrist pain (ulnar sided) 237135 0
Condition category
Condition code
Musculoskeletal 237458 237458 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Custom-made Ulnar gutter splint applied using velcro straps by the participant. It is to be 23 hours per day for 6 weeks, and can be removed for hygiene only.

Measures of pain and function (according to the Patient Rated Wrist and Hand Evaluation) will be compared pre- and post-treatment
Intervention code [1] 236852 0
Treatment: Other
Comparator / control treatment
no control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 238265 0
score on Patient Rated Wrist and Hand evaluation (function subscale)
Timepoint [1] 238265 0
before commencing treatment and 12 weeks after this.
Secondary outcome [1] 300079 0
score on Patient Rated Wrist and Hand evaluation (pain subscale)
Timepoint [1] 300079 0
before commencing treatment and 12 weeks after this.

Eligibility
Key inclusion criteria
All people currently on elective surgery wait lists at Alfred Hospital for treatment of ulnar sided wrist pain
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded from the study if they (or their carer / guardian) are not able to provide informed consent, or if they are not able to speak or comprehend the English language

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
n/a
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2009
Actual
20/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 237241 0
Hospital
Name [1] 237241 0
Alfred Research Trusts
Country [1] 237241 0
Australia
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
Commercial Rd
Prahran 3181
Victoria
Country
Australia
Secondary sponsor category [1] 236728 0
None
Name [1] 236728 0
Address [1] 236728 0
Country [1] 236728 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239342 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 239342 0
Commercial Rd
PRAHRAN 3181
Victoria
Ethics committee country [1] 239342 0
Australia
Date submitted for ethics approval [1] 239342 0
01/07/2009
Approval date [1] 239342 0
19/10/2009
Ethics approval number [1] 239342 0
1/09/0248

Summary
Brief summary
To investigate whether splinting and activity modification can make a clinically significant change to pain levels and day-to-day function in people with this condition.
As this is a pilot study, all subjects will receive the same treatment. Comparison will be pre- and post- treatment measures
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29829 0
Dr Lisa O'Brien
Address 29829 0
Occupational Therapy
The Alfred
55 Commercial Rd
Melbourne 3004
Victoria
Australia
Country 29829 0
Australia
Phone 29829 0
+61390763230
Fax 29829 0
Email 29829 0
[email protected]
Contact person for public queries
Name 13076 0
Dr Lisa O'Brien
Address 13076 0
Occupational Therapy
The Alfred
Commercial Rd
Prahran 3181
Victoria
Country 13076 0
Australia
Phone 13076 0
+613 9076 3526
Fax 13076 0
Email 13076 0
[email protected]
Contact person for scientific queries
Name 4004 0
Dr Lisa O'Brien
Address 4004 0
Occupational Therapy
The Alfred
Commercial Rd
Prahran 3181
Victoria
Country 4004 0
Australia
Phone 4004 0
+613 9076 3526
Fax 4004 0
Email 4004 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.