Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000343202
Ethics application status
Approved
Date submitted
1/05/2009
Date registered
25/05/2009
Date last updated
9/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Specific Treatment Of Problems of the Spine (STOPS) Trials: Specific physiotherapy treatment and advice versus advice alone for sub-acute reducible discogenic low back pain: a randomised controlled trial.
Scientific title
Effects of specific physiotherapy treatment and advice versus advice alone on pain and function for people with sub-acute reducible discogenic low back pain: a randomised controlled trial.
Secondary ID [1] 285814 0
Nil known
Universal Trial Number (UTN)
Trial acronym
STOPS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reducible discogenic low back pain 4706 0
Condition category
Condition code
Musculoskeletal 5022 5022 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 237136 237136 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten sessions of specific physiotherapy management over 10 weeks, involving 30 minute sessions. Frequency of sessions will be individually tailored based on the individual's progress. Generally, participants will initially attend two sessions per week for the first fortnight and then will attend the final 6 sessions spread out over the final eight weeks. Management will include specific lumbar spine directional preference exercises, taping of the lumbar spine, a gradually progressed core stability exercise program and condition specific advice and education.
Intervention code [1] 4469 0
Treatment: Other
Comparator / control treatment
Two sessions of physiotherapy advice over a 10 week period (involving one 30 minute session directly following randomisation and another 30 minute session 5 weeks following randomisation). The sessions will involve condition specific advice regarding the prognosis and self-management of the condition.
Control group
Active

Outcomes
Primary outcome [1] 5861 0
Back specific function (Oswestry Low Back Pain Disability Questionnaire).
Timepoint [1] 5861 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [2] 5862 0
Back pain intensity on a 0-10 Numerical Rating Scale
Timepoint [2] 5862 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Primary outcome [3] 5863 0
Leg pain intensity on a 0-10 Numerical Rating Scale
Timepoint [3] 5863 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [1] 241891 0
7 point Global Perceived Effect scale
Timepoint [1] 241891 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [2] 241892 0
Quality of Life (EuroQOL)
Timepoint [2] 241892 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [3] 241893 0
Rate and nature of adverse events (therapist reporting and open questions to participants). Examples may include increased or new onset of musculoskeletal symptoms, muscular soreness associated with exercises and any others that are reported or observed.
Timepoint [3] 241893 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [4] 241894 0
Participant satisfaction (with treatment and outcome) measured on a 5 point scale ranging from "Very Dissatisfied" to "Very Satisfied"
Timepoint [4] 241894 0
At baseline, 5 weeks, 10 weeks, 26 weeks and 1 year following randomisation.
Secondary outcome [5] 311877 0
Sciatica Frequency and Bothersomeness Scale
Timepoint [5] 311877 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [6] 311878 0
Orebro musculoskeletal pain questionnaire
Timepoint [6] 311878 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [7] 311879 0
Number of work days missed in the last 30 days
Timepoint [7] 311879 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation
Secondary outcome [8] 311880 0
Interference with work/housework in the last week, measured on a 5-point scale from "not at all" to "extremely".
Timepoint [8] 311880 0
At baseline, and 5, 10, 26 and 52 weeks following randomisation

Eligibility
Key inclusion criteria
Reducible low back pain (with or without associated leg pain) with a directional preference for extension with or without a lateral component, for a 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
Volunteers without reducible discogenic low back pain, that is, those without a directional preference for extension (with or without a lateral component). Previous lumbar spine surgery. Lower limb radiculopathy attributable to disc herniation. Active cancer. Cauda equina syndrome or progressive lower limb weakness. Compensable injury. Pregnancy. 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 one of the treatment groups. 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 randomisation schedule will be generated prior to the commencement of the trial by a researcher at La Trobe University who will have no contact with participants. 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 treatment and advice 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
29/06/2009
Actual
17/08/2009
Date of last participant enrolment
Anticipated
Actual
30/03/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1643 0
3000
Recruitment postcode(s) [2] 1644 0
3147
Recruitment postcode(s) [3] 1645 0
3175
Recruitment postcode(s) [4] 1646 0
3046
Recruitment postcode(s) [5] 1647 0
3074
Recruitment postcode(s) [6] 1648 0
3220
Recruitment postcode(s) [7] 1649 0
3021
Recruitment postcode(s) [8] 1650 0
3083
Recruitment postcode(s) [9] 1651 0
3181
Recruitment postcode(s) [10] 1652 0
3199
Recruitment postcode(s) [11] 1653 0
3029
Recruitment postcode(s) [12] 1654 0
3214
Recruitment postcode(s) [13] 1655 0
3136

Funding & Sponsors
Funding source category [1] 4884 0
Commercial sector/Industry
Name [1] 4884 0
LifeCare Health (a division of Health Networks Australia)
Country [1] 4884 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] 4416 0
None
Name [1] 4416 0
Address [1] 4416 0
Country [1] 4416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6949 0
Faculty Human Ethics Committee
Ethics committee address [1] 6949 0
La Trobe University Faculty of Health Sciences Victoria Bundoora 3086
Ethics committee country [1] 6949 0
Australia
Date submitted for ethics approval [1] 6949 0
27/02/2009
Approval date [1] 6949 0
15/06/2009
Ethics approval number [1] 6949 0
FHEC09/57

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 reducible discogenic low back pain (with or without associated leg symptoms).
A secondary aim is to determine the perspectives of participants on the specific physiotherapy treatment and advice utilised in the trial.
Trial website
Trial related presentations / publications
Publication(s) pending
Public notes

Contacts
Principal investigator
Name 29557 0
Mr Luke Surkitt
Address 29557 0
School of Physiotherapy La Trobe University Bundoora Victoria 3086
Country 29557 0
Australia
Phone 29557 0
+61 417 336 307
Fax 29557 0
Email 29557 0
[email protected]
Contact person for public queries
Name 12804 0
Mr Luke Surkitt
Address 12804 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria 3086
Country 12804 0
Australia
Phone 12804 0
+61 417 336 307
Fax 12804 0
+61 3 9885 8668
Email 12804 0
[email protected]
Contact person for scientific queries
Name 3732 0
Dr Dr Jon Ford
Address 3732 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria 3086
Country 3732 0
Australia
Phone 3732 0
+61 422 244 183
Fax 3732 0
Email 3732 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
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Documents added automatically
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