Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000412235
Ethics application status
Approved
Date submitted
4/05/2009
Date registered
4/06/2009
Date last updated
9/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Specific Treatment of Problems of the Spine (STOPS) Trials: Effects of specific physiotherapy functional restoration and advice versus advice alone for people with sub-acute non-reducible discogenic low back pain.
Scientific title
Effects of specific physiotherapy functional restoration and advice versus advice alone on pain and function in people with sub-acute non-reducible discogenic low back pain: a pilot randomised controlled trial
Secondary ID [1] 252098 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar non-reducible discogenic pain 4716 0
Condition category
Condition code
Musculoskeletal 5037 5037 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 5038 5038 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten sessions (30 minutes) of physiotherapy functional restoration over a 10-week period. This will involve core stabilising exercises, progressive functional exercises, and condition-specific education and advice. Frequency will be twice a week initially, progressing to fortnightly towards the end of the program.
Intervention code [1] 4482 0
Treatment: Other
Intervention code [2] 4483 0
Rehabilitation
Comparator / control treatment
Two sessions (30 minutes ) of physiotherapy advice over a 10-week period. This will involve condition-specific advice regarding the prognosis and self-management of the condition. The frequency of the sessions will be: first session will be as soon as possible following randomisation, with the second at 5 weeks following randomisation.
Control group
Active

Outcomes
Primary outcome [1] 5876 0
Back-specific function (Oswestry Low Back Pain Disability Questionnaire)
Timepoint [1] 5876 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [2] 5877 0
Back pain intensity on a 0-10 Numerical Rating Scale
Timepoint [2] 5877 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [3] 5878 0
Leg pain intensity on a 0-10 Numerical Rating Scale
Timepoint [3] 5878 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [1] 241906 0
7-point global perceived effect scale
Timepoint [1] 241906 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [2] 241907 0
Quality of Life (EuroQOL)
Timepoint [2] 241907 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [3] 241908 0
Rate and nature of adverse events (therapist reporting and open questions to participants). The adverse events will be documented on a recording form. Adverse events will be categorised into minor, significant, and serious.

Minor adverse event - any symptom or event reported that may potentially be related to the intervention. eg short term pain associated with exercises.

Significant - any symptom or event potentially related to the intervention that interrupts the participants ability to continue with the Randomised controlled trail (RCT) intervention. eg deterioration in leg symptoms for more than 1 week.

Serious adverse event - any symptom or event potentially related to the intervention that results in admission to hospital or permanent disability, or is life threatening.
Timepoint [3] 241908 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [4] 241909 0
Deyo's core outcomes questionnaire:
- Patient satisfaction with treatment and outcome (5 point scale from "very dissatisfied" to "very satisfied" )
Timepoint [4] 241909 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [5] 311871 0
Orebro musucloskeletal pain screening questionaire
Timepoint [5] 311871 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [6] 311872 0
Sciatica frequency and bothersomeness scale
Timepoint [6] 311872 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [7] 311873 0
Deyo's core outcomes questionnaire:
- Number of work days missed in the last 30 days
Timepoint [7] 311873 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [8] 311874 0
Deyo's core outcomes questionnaire:
- Interference with work/housework in the last week (5 point scale from "not at all" to "extremely")
Timepoint [8] 311874 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation

Eligibility
Key inclusion criteria
lower back pain with or without associated leg pain, pins and needles, or numbness for a duration of 6 weeks to 6 months

free of back/leg symptoms for at least 4 weeks prior to the current episode

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
Causes of symptoms other than lumbar non-reducible discogenic pain (eg Lower limb radiculopathy attributable to Lumbar disc herniation, reducible discogenic pain, facetogenic pain, spondylolisthesis, bony or ligamentous stenosis). Previous lumbar spine surgery. Compensable injury. Cauda equina syndrome or progressive lower limb weakness. Had injections into the back in the previous 6 weeks. 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 medical practitioner or health care 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 the functional restoration or advice group. This will be done by the assessor contacting an off-site trial administrator who will hold the randomisation schedule, and will not be involved in assessing, enrolling 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. Permuted block randomisation with random block sizes will be undertaken using a web-based randomisation program. Randomisation will be stratified by developing a separate schedule for each of the 14 physiotherapy 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 functional restoration group will be invited to attend a one-on-one semi-structured interview at the completion of the 10-week intervention period to gain their perspectives on the treatment program.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
23/07/2009
Date of last participant enrolment
Anticipated
Actual
30/03/2012
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] 4892 0
Commercial sector/Industry
Name [1] 4892 0
Health Networks Australia / LifeCare Health
Country [1] 4892 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
School of Physiotherapy Faculty of Health Sciences, Bundoora, Victoria 3086
Country
Australia
Secondary sponsor category [1] 4426 0
None
Name [1] 4426 0
Address [1] 4426 0
Country [1] 4426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6957 0
Ethics committee address [1] 6957 0
Ethics committee country [1] 6957 0
Date submitted for ethics approval [1] 6957 0
23/03/2009
Approval date [1] 6957 0
07/07/2009
Ethics approval number [1] 6957 0

Summary
Brief summary
The primary aim of this trial is to compare the outcomes and adverse events of two different physiotherapy treatment approaches for people with lumbar non-reducible discogenic pain.
A secondary aim is to determine the perspectives of participants on the functional restoration program utilised in the trial.
Trial website
Trial related presentations / publications
Hahne, A.J., et al., Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders. BMC Musculoskelet Disord, 2011. 12(1): p. 104.
Public notes

Contacts
Principal investigator
Name 29566 0
Mr Alexander Chan
Address 29566 0
School of Physiotherapy La Trobe University Bundoora Victoria 3086
Country 29566 0
Australia
Phone 29566 0
+61 431 789 237
Fax 29566 0
Email 29566 0
[email protected]
Contact person for public queries
Name 12813 0
Alexander Chan
Address 12813 0
School of Physiotherapy
La Trobe University
Bundoora Victoria 3086
Country 12813 0
Australia
Phone 12813 0
+61 431 789 237
Fax 12813 0
Email 12813 0
[email protected]
Contact person for scientific queries
Name 3741 0
Dr Megan Davidson
Address 3741 0
School of Physiotherapy
La Trobe University
Bundoora Victoria 3086
Country 3741 0
Australia
Phone 3741 0
+61 3 9479 5798
Fax 3741 0
Email 3741 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
SourceTitleYear of PublicationDOI
EmbaseIndividualised functional restoration plus guideline-based advice vs advice alone for non-reducible discogenic low back pain: a randomised controlled trial.2017https://dx.doi.org/10.1016/j.physio.2016.08.001
N.B. These documents automatically identified may not have been verified by the study sponsor.