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Trial registered on ANZCTR


Registration number
ACTRN12609000334202
Ethics application status
Approved
Date submitted
29/04/2009
Date registered
22/05/2009
Date last updated
16/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Specific Treatment Of Problems of the Spine (STOPS) Trials: Manual Therapy Group
Scientific title
Effects of Physiotherapy manual therapy on pain and function for people with sub acute low back pain with or without leg pain: A randomised controlled trial
Secondary ID [1] 251708 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
STOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subacute low back pain with or without leg pain 4687 0
Condition category
Condition code
Musculoskeletal 5000 5000 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 5001 5001 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten 30 minute sessions of physiotherapy over a 10-week period. This will involve a well defined manual therapy program, including mobilisation and or manipulation, and core lumbar stabilising exercises. These involve gentle contractions of the pelvic floor, lower abdomen and deep paraspinal muscles and will be taught in positions of side-lying, 4 point kneeling and standing. Treatment will take place twice weekly to begin with, then move to weekly and finally to fortnightly over the ten week period.
Intervention code [1] 4449 0
Treatment: Other
Intervention code [2] 4450 0
Rehabilitation
Comparator / control treatment
Two 30 minute sessions of physiotherapy advice over a 10-week period. This will involve condition specific advice regarding the prognosis and self-management of the condition. The first will take place shortly after randomisation and the second 6 weeks after randomisation.
Control group
Active

Outcomes
Primary outcome [1] 5841 0
Back-specific function (Oswestry Low Back Pain Disability Questionnaire)
Timepoint [1] 5841 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [2] 5842 0
Back pain intensity on a 0-10 Numerical Rating Scale
Timepoint [2] 5842 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [3] 292676 0
Leg pain intensity on 0-10 numerical rating scale
Timepoint [3] 292676 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [1] 241851 0
7-point global perceived effect scale
Timepoint [1] 241851 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [2] 241852 0
Quality of Life (EuroQOL)
Timepoint [2] 241852 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [3] 309486 0
Participant satisfaction (with treatment and outcome) measured on a 5 point scale from "very dissatisfied" to "very satisfied"
Timepoint [3] 309486 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [4] 309487 0
Number of work days missed in the last 30 days
Timepoint [4] 309487 0
At baseline, 5 weeks, 10 weeks 26 weeks and 1 year following randomisation
Secondary outcome [5] 309488 0
Interference with work/housework in the last week, measured on a 5 point scale from "not at all" to "extremely".
Timepoint [5] 309488 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [6] 309489 0
Orebro Musculoskeletal Pain questionnaire
Timepoint [6] 309489 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [7] 309490 0
Sciatica Frequency and Bothersomeness Scale
Timepoint [7] 309490 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation
Secondary outcome [8] 309491 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 associated with exercise, and any others that are observed.
Timepoint [8] 309491 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.

Eligibility
Key inclusion criteria
Low back pain with or without leg pain that will respond to manual therapy, with a 6 week to 6 months duration. 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
Disc herniation with radiculopathy, reducible discogenic pain or non reducible discogenic pain.
Cause of symptoms due to serious pathology such as cauda equina syndrome or spinal tumour.
Previous lumbar spine surgery. Compensable injury. Cauda equina syndrome of 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 practitioner 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 manual therapy 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 the 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 13 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 manual therapy group will be invited to attend a one-on-one semi structured interview at the completion of the intervention period to gain their perspectives on the 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] 4867 0
Commercial sector/Industry
Name [1] 4867 0
Health Networks Australia / LifeCare Health
Address [1] 4867 0
Level 1, 416 High Street, Kew, VIC, 3101
Country [1] 4867 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] 4403 0
None
Name [1] 4403 0
Address [1] 4403 0
Country [1] 4403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6929 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 6929 0
La Trobe University, Bundoora, 3086
Ethics committee country [1] 6929 0
Date submitted for ethics approval [1] 6929 0
18/03/2009
Approval date [1] 6929 0
29/07/2009
Ethics approval number [1] 6929 0

Summary
Brief summary
The primary aim of the this trial is to compare the outcomes and adverse events of two different physiotherapy treatment approaches for people with sub acute low back pain with or leg pain. A secondary aim is to determine the perspectives of participants on the manual therapy program utilised in the trial.
Trial website
http://www.latrobe.edu.au/health/research/stops
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29543 0
Dr Jon Ford
Address 29543 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria 3086
Country 29543 0
Australia
Phone 29543 0
+ 61 422 244 183
Fax 29543 0
Email 29543 0
j.ford@latrobe.edu.au
Contact person for public queries
Name 12790 0
Dr Sarah Slater
Address 12790 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria 3086
Country 12790 0
Australia
Phone 12790 0
+61 404 433 164
Fax 12790 0
Email 12790 0
slslater@internode.on.net
Contact person for scientific queries
Name 3718 0
Dr Jon Ford
Address 3718 0
School of Physiotherapy
La Trobe University
Victoria 3086
Country 3718 0
Australia
Phone 3718 0
+ 61 422 244 183
Fax 3718 0
Email 3718 0
jonford@pac.cm.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