Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000102976
Ethics application status
Not yet submitted
Date submitted
25/01/2011
Date registered
31/01/2011
Date last updated
31/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of forearm strengthening exercises in osteoarthritis of the small joints of the hand
Scientific title
In adults with primary osteoarthritis of the small joints of the hand, is a 12 week program of forearm strengthening exercises more effective than no exercises for improving pain and function?
Secondary ID [1] 253481 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary osteoarthritis of small joints of the hand 261035 0
Condition category
Condition code
Musculoskeletal 259171 259171 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
12 weeks of forearm strengthening exercises, to be done at home by participants, consisting of a series of seven brief exercises performed ten times daily. Each set of exercises should take 3-5 minutes to complete.
Full explanation of exercises will be given.
Continue usual pain medications.
Intervention code [1] 257916 0
Treatment: Other
Intervention code [2] 257922 0
Rehabilitation
Comparator / control treatment
Usual pain medications. No exercises
Control group
Active

Outcomes
Primary outcome [1] 262023 0
Pain in hands using a patient pain visual analogue scale, patient global visual analogue scale and physician global visual analogue scale.
Timepoint [1] 262023 0
12 weeks
Secondary outcome [1] 268968 0
Function in hands using cochin hand functional disability scale
Timepoint [1] 268968 0
12 weeks

Eligibility
Key inclusion criteria
Painful osteoarthritis of small joints of the hand
Pain visual analogue score >4
Stable analgesic dose in 4 weeks prior to inclusion
Age > 18 years old
Ability to give informed consent and comply with exercises
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Corticosteroids within last 3 months
Diagnosis of inflammatory joint condition
Unable to give informed consent

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)
Allocation concealment via sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (ie. computerised sequence generation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258405 0
Self funded/Unfunded
Name [1] 258405 0
Country [1] 258405 0
Primary sponsor type
Hospital
Name
Westmead Hospital, Department of Rheumatology
Address
PO Box 533
Wentworthville, NSW, 2145
Country
Australia
Secondary sponsor category [1] 257555 0
None
Name [1] 257555 0
Address [1] 257555 0
Country [1] 257555 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260366 0
Ethics committee address [1] 260366 0
Ethics committee country [1] 260366 0
Date submitted for ethics approval [1] 260366 0
01/02/2011
Approval date [1] 260366 0
Ethics approval number [1] 260366 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32135 0
Address 32135 0
Country 32135 0
Phone 32135 0
Fax 32135 0
Email 32135 0
Contact person for public queries
Name 15382 0
Dr Andrew Jordan
Address 15382 0
Department of Rheumatology, Westmead Hospital, PO Box 533, Wentworthville, NSW, 2145
Country 15382 0
Australia
Phone 15382 0
+61 2 98458099
Fax 15382 0
+61 2 98458317
Email 15382 0
[email protected]
Contact person for scientific queries
Name 6310 0
Dr Andrew Jordan
Address 6310 0
Department of Rheumatology, Westmead Hospital, PO Box 533, Wentworthville, NSW, 2145
Country 6310 0
Australia
Phone 6310 0
+61 2 98458099
Fax 6310 0
+61 2 98458317
Email 6310 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.