Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000458437
Ethics application status
Approved
Date submitted
29/08/2007
Date registered
11/09/2007
Date last updated
12/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Telephone coaching for return to usual activity.
Scientific title
Randomised control trial of telephone coaching versus usual care in non-chronic non-specific low back pain to reduce activity limitation
Secondary ID [1] 252856 0
Telephone coaching for return to usual activity.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-specific low back pain (NSLBP) 2308 0
Condition category
Condition code
Musculoskeletal 2408 2408 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telephone-based health coaching in addition to usual physiotherapy care. Coaching will assess the importance of return to usual activity for the participant and if necessary use motivational interviewing and cognitive behavioural techniques to increase the importance. Coaching will also assess the participant's confidence to return to usual activities and apply goal setting and action plans to increase confidence to return. Particiapants will be coached once per week for four weeks and once three weeks after the fourth session. Each coaching session will last approximately 30 minutes.
Intervention code [1] 2029 0
Treatment: Other
Comparator / control treatment
Usual care physiotherapy treatment (including referral to other health care services) as deemed necessary by the treating physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 3306 0
Mean difference on Oswestry disability index
Timepoint [1] 3306 0
Baseline, 4, 12 weeks after randomisation.
Primary outcome [2] 3307 0
Mean difference on modified Patient Specific Functional scale
Timepoint [2] 3307 0
Baseline, 4, 12 weeks after randomisation
Secondary outcome [1] 5508 0
Mean difference on pain Self Efficacy Questionnaire
Timepoint [1] 5508 0
Baseline, 4, 12 weeks after randomisation.
Secondary outcome [2] 5509 0
Mean difference on Kessler 10 questionnaire
Timepoint [2] 5509 0
Baseline, 4, 12 weeks after randomisation.
Secondary outcome [3] 5510 0
Number of physiotherapy treatment sessions
Timepoint [3] 5510 0
12 weeks after randomisation.
Secondary outcome [4] 5511 0
Mean difference in recovery expectation for return to usual activity
Timepoint [4] 5511 0
Baseline, 4, 12 weeks after randomisation.

Eligibility
Key inclusion criteria
NSLBP for less than 8 weeks duration (first or new episode). Recovery expectation less than 8 out of 10 for return to all activities in next month. English speaking. Access to telephone.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Low back pain due to a specific pathology NSLBP episode longer than 8 weeks. Histroy of surgery for back pain

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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2568 0
University
Name [1] 2568 0
La Trobe University
Country [1] 2568 0
Australia
Primary sponsor type
Individual
Name
Ross Iles
Address
School of Physiotherapy
La Trobe University
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 2323 0
Individual
Name [1] 2323 0
Professor Nicholas Taylor
Address [1] 2323 0
School of Physiotherapy
La Trobe University
Bundoora VIC 3086
Country [1] 2323 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4489 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 4489 0
Ethics committee country [1] 4489 0
Australia
Date submitted for ethics approval [1] 4489 0
03/09/2007
Approval date [1] 4489 0
27/09/2007
Ethics approval number [1] 4489 0
FHEC07/166
Ethics committee name [2] 259854 0
Eastern Health Researc and Ethics Committee
Ethics committee address [2] 259854 0
Ethics committee country [2] 259854 0
Australia
Date submitted for ethics approval [2] 259854 0
13/02/2008
Approval date [2] 259854 0
13/02/2008
Ethics approval number [2] 259854 0
E21/0708

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

Contacts
Principal investigator
Name 28015 0
Address 28015 0
Country 28015 0
Phone 28015 0
Fax 28015 0
Email 28015 0
Contact person for public queries
Name 11172 0
Ross Iles
Address 11172 0
School of Physiotherapy
La Trobe University
Bundoora VIC 3086
Country 11172 0
Australia
Phone 11172 0
+61 3 94795851
Fax 11172 0
Email 11172 0
r.iles@latrobe.edu.au
Contact person for scientific queries
Name 2100 0
Ross Iles
Address 2100 0
School of Physiotherapy
La Trobe University
Bundoora VIC 3086
Country 2100 0
Australia
Phone 2100 0
+61 3 94795851
Fax 2100 0
Email 2100 0
r.iles@latrobe.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
No additional documents have been identified.