Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000834257
Ethics application status
Yes
Date submitted
22/09/2009
Date registered
24/09/2009
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Specific Treatment Of Problems of the Spine (STOPS) Trials
Scientific title
Effects of specific physiotherapy versus advice on pain and function for people with low back pain with or without sciatica: A randomised controlled trial.
Secondary ID [1] 252799 0
Nil
Universal Trial Number (UTN)
Trial acronym
STOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain with or without sciatica 243883 0
Condition category
Condition code
Musculoskeletal 252058 252058 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 252059 252059 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten sessions (each session 30 minutes one on one) of specific physiotherapy over a 10-week period dependent on the type of back problem the participant has. The treatment will be selected on a case by case basis from directional preference management, manual therapy, cognitive behavioural strategies, core stabilising exercises, progressive functional exercises, condition-specific education and advice.
Intervention code [1] 241316 0
Other interventions
Comparator / control treatment
Two sessions (each session 30 minutes one on one) of physiotherapy advice 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] 252958 0
Back-specific function (Oswestry Low Back Pain Disability Questionnaire)
Timepoint [1] 252958 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [1] 257691 0
Leg pain intensity on a 0-10 Numerical Rating Scale
Timepoint [1] 257691 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [2] 257692 0
Back pain intensity on a 0-10 Numerical Rating Scale
Timepoint [2] 257692 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [3] 257693 0
7-point global perceived effect scale.
Timepoint [3] 257693 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [4] 257694 0
Quality of Life (EuroQOL)
Timepoint [4] 257694 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [5] 257695 0
Sciatica Frequency and Bothersomeness Scale
Timepoint [5] 257695 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [6] 257696 0
Rate and nature of adverse events (therapist reporting and open questions to participants)
Timepoint [6] 257696 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [7] 257697 0
Participant satisfaction (with treatment and outcome)
Timepoint [7] 257697 0
At baseline, and 5, 10, and 26 weeks following randomisation.
Secondary outcome [8] 297686 0
Effect modifiers (duration of symptoms, Orebro Musculoskeletal Pain Screening Questionnaire total score, clinical features of inflammation, number of positive subgroup features based on the STOPS classification system, therapist experience, coping item from the Orebro Musculoskeletal Pain Screening Questionnaire, subgroup membership based on the STOPS classification system, baseline score on the Oswestry Disability Scale, back pain - numerical rating scale and leg pain - numerical rating scale)
Timepoint [8] 297686 0
26 weeks

Eligibility
Key inclusion criteria
Low back pain with or without sciatica for duration of 6 weeks to 6 months.

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 sciatica symptoms (if present) 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 specific physiotherapy 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 specific physiotherapy 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
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Open to recruitment
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 253117 0
State/province [1] 253117 0

Funding & Sponsors
Funding source category [1] 243768 0
Commercial sector/Industry
Name [1] 243768 0
Health Networks Australia / LifeCare Health
Country [1] 243768 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Health Networks Australia/LifeCare Health
Address
Level 1, 416 High Street Kew VIC 3101
Country
Australia
Secondary sponsor category [1] 237126 0
University
Name [1] 237126 0
La Trobe University
Address [1] 237126 0
School of Physiotherapy Faculty of Health Sciences Victoria 3086
Country [1] 237126 0
Australia

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 243898 0
Faculty Human Ethics Committee
Ethics committee address [1] 243898 0
Ethics committee country [1] 243898 0
Australia
Date submitted for ethics approval [1] 243898 0
Approval date [1] 243898 0
19/12/2008
Ethics approval number [1] 243898 0
FHEC08 / 196

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

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

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.