Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000293268
Ethics application status
Approved
Date submitted
1/05/2009
Date registered
18/05/2009
Date last updated
27/11/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Specific Treatment Of Problems of the Spine (STOPS) Trials: Effect of advice versus physiotherapy functional restoration on pain and function for people with multi-factorial persistent low back pain.
Scientific title
Effects of advice versus physiotherapy functional restoration on pain and function for people with multi-factorial persistent low back pain: A randomised controlled trial.
Secondary ID [1] 281999 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multi-factorial persistent low back pain 4702 0
Condition category
Condition code
Physical Medicine / Rehabilitation 5016 5016 0 0
Physiotherapy
Musculoskeletal 5017 5017 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten sessions of physiotherapy functional restoration (30 minute sessions at variable frequency) over a 10-week period. This will involve specific education and advice regarding condition, specific cognitive behavioural strategies, core stabilising exercises and progressive functional exercises.
Intervention code [1] 4464 0
Treatment: Other
Intervention code [2] 4465 0
Rehabilitation
Comparator / control treatment
Two sessions of physiotherapy advice (30 minute sessions at both 1 and 5 weeks following randomisation) over a 10-week period. This will involve condition-specific advice regarding the prognosis and self-management of the condition.
Control group
Active

Outcomes
Primary outcome [1] 5856 0
Back-specific function (Oswestry Low Back Pain Disability Questionnaire)
Timepoint [1] 5856 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [2] 5857 0
Back pain intensity on a 0-10 Numerical Rating Scale
Timepoint [2] 5857 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [3] 293704 0
Leg pain intensity on a 0-10 Numerical Rating Scale
Timepoint [3] 293704 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [1] 241884 0
7-point global perceived effect scale.
Timepoint [1] 241884 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [2] 241885 0
Quality of Life (EuroQOL)
Timepoint [2] 241885 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [3] 241886 0
Rate and nature of adverse events (therapist reporting and open questions to participants). Examples may include new musculoskeletal conditions and muscular soreness associated with exercise.
Timepoint [3] 241886 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [4] 241887 0
Participant satisfaction (with treatment and outcome) measured on a 5-point scale.
Timepoint [4] 241887 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [5] 311636 0
Number of work days missed in the last 30 days
Timepoint [5] 311636 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [6] 311637 0
Interference with work/housework in the last week, measured on a 5-point scale from "not at all" to "extremely"
Timepoint [6] 311637 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [7] 311638 0
Orebro Musculoskeletal Pain Screening questionnaire
Timepoint [7] 311638 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [8] 311639 0
Sciatica Frequency and Bothersomeness scale
Timepoint [8] 311639 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.

Eligibility
Key inclusion criteria
Low back pain for duration of 6 weeks to 6 months. Scoring >105 on the Orebro pain screening questionnaire. Able to understand and read English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Trial assessment diagnoses including: low back disc herniation with radiculopathy, discogenic low back pain (either responsive or not responsive to repeated movement), and low back pain responsive to manual therapy.
Other pathology such as severe upper/lower motor neuron dysfunction. Previous lumbar spine surgery. Compensable injury. Active cancer. Inability to walk safely.

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)
Volunteers who respond to advertising, or who are referred by a healthcare professional, will undergo a phone screening and baseline physical assessment to determine eligibility. Eligible volunteers who consent to participate will complete baseline outcome measures prior to being randomised to either the control or treatment group. The randomisation process involves the assessor contacting an off-site trial administrator who will control the randomisation schedule, and will not be involved in enrolling, assessing or treating participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher at La Trobe University who will have no contact with participants will generate a randomisation schedule prior to trial commencement. A web-based randomisation program utilising permuted block randomisation with random block sizes will be used. There will be a separate schedule for each of the 14 treatment clinics.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All participants who are allocated to the treatment group will be invited to attend a one-on-one semi-structured interview at the completion of the 10-week intervention period, to assist in gaining their perspectives on the treatment program.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
8/05/2009
Actual
16/07/2009
Date of last participant enrolment
Anticipated
Actual
3/08/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4881 0
Commercial sector/Industry
Name [1] 4881 0
Health Networks Australia / LifeCare Health
Country [1] 4881 0
Australia
Primary sponsor type
University
Name
School of Physiotherapy
Address
Faculty of Health Sciences
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country
Australia
Secondary sponsor category [1] 4413 0
None
Name [1] 4413 0
Address [1] 4413 0
Country [1] 4413 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6946 0
Faculty Human Ethics Committee
Ethics committee address [1] 6946 0
Ethics committee country [1] 6946 0
Australia
Date submitted for ethics approval [1] 6946 0
Approval date [1] 6946 0
09/04/2009
Ethics approval number [1] 6946 0
FHEC09 / 64

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

Contacts
Principal investigator
Name 29554 0
Mr Matt Richards
Address 29554 0
School of Physiotherapy La Trobe University Kingsbury Drive Bundoora Victoria 3086
Country 29554 0
Australia
Phone 29554 0
+61 408 775 066
Fax 29554 0
Email 29554 0
mc4richards@students.latrobe.edu.au
Contact person for public queries
Name 12801 0
Matt Richards
Address 12801 0
School of Physiotherapy
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country 12801 0
Australia
Phone 12801 0
+61 408 775 066
Fax 12801 0
+61 3 9473 8785
Email 12801 0
mc4richards@students.latrobe.edu.au
Contact person for scientific queries
Name 3729 0
Jon Ford
Address 3729 0
School of Physiotherapy
La Trobe University
Kingsbury Drive
Bundoora
Victoria 3086
Country 3729 0
Australia
Phone 3729 0
+61 3 9479 5793
Fax 3729 0
+61 3 9473 8785
Email 3729 0
j.ford@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.