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Trial registered on ANZCTR


Registration number
ACTRN12609000205235
Ethics application status
Approved
Date submitted
5/03/2009
Date registered
23/04/2009
Date last updated
18/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Specific Treatment Of Problems of the Spine (STOPS) Trials: Effects of advice versus physiotherapy functional restoration on pain and function for people with lumbar disc herniation and associated radiculopathy.
Scientific title
Effects of advice versus physiotherapy functional restoration on pain and function for people with lumbar disc herniation and associated radiculopathy: A randomised controlled trial.
Secondary ID [1] 262587 0
None
Universal Trial Number (UTN)
Trial acronym
STOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lumbar disc herniation with associated radiculopathy 4426 0
Condition category
Condition code
Musculoskeletal 4692 4692 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 4693 4693 0 0
Physiotherapy

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 core stabilising exercises, progressive functional exercises, and condition-specific education and advice.
Intervention code [1] 4168 0
Treatment: Other
Intervention code [2] 4169 0
Rehabilitation
Comparator / control treatment
Two sessions of physiotherapy advice over a 10-week period (one 30-minute session directly after randomisation, and another 30-minute session 5-weeks following randomisation). This will involve condition-specific advice regarding the prognosis and self-management of the condition.
Control group
Active

Outcomes
Primary outcome [1] 5557 0
Back-specific function (Oswestry Low Back Pain Disability Questionnaire)
Timepoint [1] 5557 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Primary outcome [2] 5558 0
Leg pain intensity on a 0-10 Numerical Rating Scale
Timepoint [2] 5558 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Primary outcome [3] 5559 0
Back pain intensity on a 0-10 Numerical Rating Scale
Timepoint [3] 5559 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [1] 9362 0
7-point global perceived effect scale.
Timepoint [1] 9362 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [2] 9363 0
Quality of Life (EuroQOL)
Timepoint [2] 9363 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [3] 9364 0
Sciatica Frequency and Bothersomeness Scale
Timepoint [3] 9364 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [4] 9365 0
Rate and nature of adverse events (therapist reporting and open questions to participants). Examples may include increase or new onset of musculoskeletal or neurological symptoms, muscular soreness assoicated with exercises, and any others that are reported or observed.
Timepoint [4] 9365 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [5] 9366 0
Participant satisfaction (with treatment and outcome) measured on a 5-point scale from "very dissatisfied" to "very satisfied".
Timepoint [5] 9366 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [6] 308891 0
Orebro musculoskeletal pain questionnaire
Timepoint [6] 308891 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation.
Secondary outcome [7] 308892 0
Number of work days missed in the last 30 days
Timepoint [7] 308892 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation.
Secondary outcome [8] 308893 0
Interference with work/housework in the last week, measured on a 5-point scale from "not at all" to "extremely".
Timepoint [8] 308893 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation.

Eligibility
Key inclusion criteria
Leg pain radiating below the knee (or into the anterior thigh for high lumbar disc herniations) for duration of 6 weeks to 6 months.
At least one neurological sign (reflex deficit, sensory deficit, motor deficit, or positive straight-leg-raise).
Magnetic resonance imaging (MRI) or computerised tomography (CT) confirming the presence of a lumbar disc herniation.
Able to understand and read English.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Causes of symptoms other than disc herniation (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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4616 0
Commercial sector/Industry
Name [1] 4616 0
LifeCare Health (a division of Health Networks Australia)
Address [1] 4616 0
Level 1, 416 High Street
Kew VIC 3101
Country [1] 4616 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
School of Physiotherapy
Faculty of Health Sciences
Victoria 3086
Country
Australia
Secondary sponsor category [1] 4162 0
None
Name [1] 4162 0
Address [1] 4162 0
Country [1] 4162 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6659 0
Faculty Human Ethics Committee
Ethics committee address [1] 6659 0
La Trobe University
Faculty of Health Sciences
Victoria 3086
Ethics committee country [1] 6659 0
Australia
Date submitted for ethics approval [1] 6659 0
Approval date [1] 6659 0
19/12/2008
Ethics approval number [1] 6659 0
FHEC08 / 196

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 clinical and radiological confirmation of lumbar disc herniation with associated radiculopathy.
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
Public notes

Contacts
Principal investigator
Name 29357 0
Dr Andrew Hahne
Address 29357 0
Department of Physiotherapy
La Trobe University
Melbourne Victoria 3086
Country 29357 0
Australia
Phone 29357 0
+61 3 9479 3392
Fax 29357 0
Email 29357 0
andrewhahne@gmail.com
Contact person for public queries
Name 12604 0
Dr Andrew Hahne
Address 12604 0
School of Physiotherapy
La Trobe University
Victoria 3086
Country 12604 0
Australia
Phone 12604 0
+61 408 148 720
Fax 12604 0
Email 12604 0
a.hahne@latrobe.edu.au
Contact person for scientific queries
Name 3532 0
Prof Professor Nicholas Taylor
Address 3532 0
School of Physiotherapy
La Trobe University
Victoria 3086
Country 3532 0
Australia
Phone 3532 0
+61 3 9479 5860
Fax 3532 0
+61 3 9479 5768
Email 3532 0
n.taylor@latrobe.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary