Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000124538
Ethics application status
Approved
Date submitted
13/03/2006
Date registered
6/04/2006
Date last updated
6/04/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Chronic pain self-management in elderly Australians
Scientific title
Chronic pain in elderly Australians: Randomised controlled trial of group-based cognitive-behavioural pain self-management to reduce pain-related disability
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic non-malignant pain 1089 0
Condition category
Condition code
Alternative and Complementary Medicine 1170 1170 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group-based cognitive-behavioural pain self-management (2-hours per session) for 4 weeks (16 hours in total) versus an attention-control and exercise condition (same total time as treatment),
Intervention code [1] 885 0
Rehabilitation
Comparator / control treatment
Waiting-list control condition (continue existing treatments and assess 3-months apart)
Control group
Active

Outcomes
Primary outcome [1] 1574 0
Pain-related disability
Timepoint [1] 1574 0
At 1-, 6- and 12-months post-treatment
Secondary outcome [1] 2853 0
Quality of life
Timepoint [1] 2853 0
At 1, 6 and 12 months post-treatment.
Secondary outcome [2] 2854 0
Pain-related use of health services
Timepoint [2] 2854 0
At 1, 6 and 12 months post-treatment.

Eligibility
Key inclusion criteria
(i) Able to attend the clinic twice-weekly for 4-weeks, (ii) history of persisting, non-cancer pain for more than 6-months, (iii) ability to read and speak adequate English, and to complete questionnaires, (iv) score of 24 or greater in Mini Mental State Examination, (v) medical clearance by their doctors for participation in a light exercise and stretch program and (vi) agreement to accept randomisation to one of the intervention groups after a full explanation of the project.And meet at least one of the following criteria: (i) Widespread reduction in normal activities due to pain and/or (ii) distressed mood secondary to pain-related problems.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) displays the presence of an active major mental disorder (e.g. psychosis, dementia, major depression with active suicidal ideation), (ii) further medical/surgical treatments or investigations are planned and (iii) displays evidence of a primary drug addiction problem.

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 is achieved by having the holder of the allocation schedule at a separate site to the assessment and treatment location.The method of allocation concealment will be central randomisation via telephone. Importantly, assessment for eligibility is not performed by staff delivering the intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
After consenting to randomisation, eligible subjects will be allocated in consecutive groups of eight to the treatment, attention control or waiting list control group by block randomisation with variable block sizes. The allocation sequence was generated using the method described by 1. Altman DG and Bland JM. How to randomise. BMJ 1999;319:703-4 and random number tables (3. Armitage P and Berry G. Statistical Methods in Medical Research (2nd edition)).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
There will be three groups:(1) the intervention treatment; (2) usual treatment/attention-control group); (3) a Waiting List Control condition (to control for the effects of time).
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
174
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1278 0
Government body
Name [1] 1278 0
Australian Health Mininsters Advisory Council’s (AHMAC) Priority driven research (PDR) Program
Country [1] 1278 0
Australia
Primary sponsor type
University
Name
Kolling Institute
Address
Country
Australia
Secondary sponsor category [1] 1132 0
University
Name [1] 1132 0
Pain Management & Research Institute
Address [1] 1132 0
Country [1] 1132 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2609 0
Pain Management & Research Institute, Royal North Shore Hospital
Ethics committee address [1] 2609 0
Ethics committee country [1] 2609 0
Australia
Date submitted for ethics approval [1] 2609 0
Approval date [1] 2609 0
11/08/2005
Ethics approval number [1] 2609 0
0506-118M(Q)

Summary
Brief summary
This project will provide for the first time a sound Australian-sourced evidence base for the effective management of this intractable problem amongst the more severely disabled elderly chronic pain sufferers. This research proposal addresses National Research Priorities of improving the mental and physical capacities (and self-reliance) of chronically-ill ageing Australians, by helping to minimise disability, improve self-reliance, workforce participation (where relevant) and quality of life in chronically-ill elderly Australians.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35471 0
Address 35471 0
Country 35471 0
Phone 35471 0
Fax 35471 0
Email 35471 0
Contact person for public queries
Name 10074 0
Associate Professor Michael K. Nicholas
Address 10074 0
Pain Management and Research Institute
Royal North Shore Hospital
St Leonards 2065 NSW
Country 10074 0
Australia
Phone 10074 0
+61 2 99267318
Fax 10074 0
+61 2 99266548
Email 10074 0
miken@med.usyd.edu.au
Contact person for scientific queries
Name 1002 0
Associate Professor Michael K. Nicholas
Address 1002 0
Pain Management and Research Institute
Royal North Shore Hospital
St Leonards 2065 NSW
Country 1002 0
Australia
Phone 1002 0
+61 2 99267318
Fax 1002 0
+61 2 99266548
Email 1002 0
miken@med.usyd.edu.au

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
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