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Trial registered on ANZCTR


Registration number
ACTRN12613000431729
Ethics application status
Approved
Date submitted
12/04/2013
Date registered
16/04/2013
Date last updated
18/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Low back pain in Primary Care: Impact of targeted treatment and cost effectiveness of a group intervention in a population of patients with non-specific low back pain
Scientific title
Management of patients with low back pain using targeted treatment based on the Startback tool to assess changes in disability (Roland Morris Disability Questionnaire)
Secondary ID [1] 282325 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 288869 0
Condition category
Condition code
Musculoskeletal 289212 289212 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 289213 289213 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Streams

Based on the results of the Startback Screening Tool (Hill 2008), patients will be assigned to one of three treatment streams: low risk, medium risk or high risk groups.

(i) Low Risk Group - Education Group
Inclusion criteria: Low Risk Score on the STarTBack Tool

Patients will attend for a 1.5 hour small group session led by a Physiotherapist relating to back education, the importance of exercise and the promotion of self management strategies. An information manual will be provided for all patients.

(ii) Medium Risk Group – Exercise/ Education Group

Inclusion criteria: Medium Risk Score on the STarTBack Tool

Patients attend four 90-minute group exercise and education sessions over four weeks and then follow a prescribed home exercise programme independently for a further eight weeks. All patients receive the Waterford back care manual containing general educational information, instruction in each exercise and a home exercise log. There will be six to ten patients per group.
All participants follow a similar programme which comprises mat based lumbar spine stability programme (flexibility, mobility and strengthening components).
The exercise component of each class is approximately 45 minutes duration.

Exercises:

Flexibility/Mobility: Hamstring stretches, piriformis stretches, calf stretches, low back stretches, extension in prone lying

Core Strengthening: transversus abdominal (TA) work in neutral, bridging, TA in prone kneeling, TA with foot lifts, leg lifts, double leg lifts. side lying bridges, gluteal strengthening exercises

With regard to home exercises:

1) Patients are directed to perform the exercises independently at home 4 times/week x 30 minutes for the duration of the programme.

2) Patients also encouraged to increase their general activity levels e.g. walking, swimming, cycling and directed to do 30 minutes of general exercise, 3 times weekly

Adherence to the programme is monitored by reviewing the patients exercise log in the manual and by monitoring attendance at the weekly classes.

(iii) High Risk Group - Cognitive behavioural therapy/Exercise

Inclusion criteria: High Risk Score on the STarTBack Tool.
Patients attend a small group session (5 patients max) once a week for four weeks. Each session is 2 hours in duration and is administered by a clinical specialist physiotherapists who have specialised training in cognitive behavioural therapy (CBT).

Sessions will utilise cognitive behavioural strategies to address unhelpful beliefs and behaviours around LBP. The CBT intervention will include the bio-psychosocial model of pain, goal setting, graded activity, relaxation training, relapse management. It will teach patients to identify and change maladaptive behaviours around their back pain and use cognitive techniques to identify unhelpful and unrealistic thoughts and beliefs, and to challenge and change them. The classes will promote positive behaviour and beliefs about physical activity and avoidance behaviour. Specific psychological and practical skills to promote self management of pain will be developed. Each session will also include an exercise component similar to what has been previously described and each patient will receive a 'programme' manual containing the relevant information and exercises.

Patients will be advised to spend 30 minutes at least four times per week conducting the exercises at home as well as adopting CBT principles e.g. pacing and goal setting. Patients will continue the exercise regime independently at home for 8 weeks following the classes.

Adherence to the programme is monitored by reviewing the patients exercise log in the manual and by monitoring attendance at the weekly classes.

On completion of the 12 week programme, patients will be forwarded the battery of questionnaires to complete and will be re-evaluated at the clinic. Long-term follow up will occur at 6 months when questionnaires will be forwarded to the patient for completion.
Intervention code [1] 286941 0
Rehabilitation
Comparator / control treatment
Control group comprise retrospective data on patients referred to the Bakcare programme at Waterford Regional Hospital (2008-2010), who fulfilled the inclusion criteria for the current study and were treated according to 'usual care' i.e. protocol for 'Medium Risk' group

(ii) Medium Risk Group – Exercise/ Education Group

Patients attend four 90-minute group exercise and education sessions over four weeks and then follow a prescribed home exercise programme independently for a further eight weeks. All patients receive the Waterford back care manual containing general educational information, instruction in each exercise and a home exercise log. There will be six to ten patients per group.
All participants follow a similar programme which comprises mat based lumbar spine stability programme (flexibility, mobility and strengthening components).
The exercise component of each class is approximately 45 minutes duration.

Exercises:

Flexibility/Mobility: Hamstring stretches, piriformis stretches, calf stretches, low back stretches, extension in prone lying

Core Strengthening: transversus abdominal (TA) work in neutral, bridging, TA in prone kneeling, TA with foot lifts, leg lifts, double leg lifts. side lying bridges, gluteal strengthening exercises

With regard to home exercise

1) Patients are directed to perform the exercises independently at home 4 times/week x 30 minutes for the duration of the programme.

2) Patients also encouraged to increase their general activity levels e.g. walking, swimming, cycling and directed to do 30 minutes of general exercise, 3 times weekly

Adherence to the programme is monitored by reviewing the patients exercise log in the manual and by monitoring attendance at the weekly classes.
Control group
Historical

Outcomes
Primary outcome [1] 289323 0
The Roland Morris Disability Questionnaire (RMDQ) will measure functional disability

Timepoint [1] 289323 0
Pre programme, post programme (12 weeks), and three months later (i.e. 6 months from beginning of the programme)
Secondary outcome [1] 302237 0
The Visual analogue Scale (VAS) will assess pain levels
Timepoint [1] 302237 0
Pre programme, post programme (12 weeks), and three months later (i.e. 6 months from beginning of the programme)
Secondary outcome [2] 302238 0
The Distress Risk Assessment Method (DRAM)
will assess anxiety and depression
Timepoint [2] 302238 0
Pre programme, post programme (12 weeks) and three months later (6 months post beginning of programme)
Secondary outcome [3] 302239 0
The Back Beliefs Questionnaire (BBQ) will assess patients back beliefs
Timepoint [3] 302239 0
Pre programme, post programme (12 weeks) and three months later (6 months post beginning of programme)
Secondary outcome [4] 302240 0
Euro-Quol will is a single index measure of quality of life for which preference weights have been developed (EuroQol Group, 1991). It is used as both a clinical and econometric measure of health outcome.

Timepoint [4] 302240 0
Pre programme, post programme (12 weeks) and three months later (6 months post beginning of programme)
Secondary outcome [5] 302241 0
Objective outcome measures:

Range of lumbar spine flexion will be measured using an inclinimeter placed on T12 and S1 as reference points (Saur 1996)
Timepoint [5] 302241 0
Pre programme, post programme (12 weeks)
Secondary outcome [6] 302242 0
50 foot walk test (Simmonds et al (1998)
Timepoint [6] 302242 0
Pre programme, post programme (12 weeks)
Secondary outcome [7] 302243 0
Cost diary
Timepoint [7] 302243 0
3 month retrospective completion of cost diary for healthcare use related to low back pain (Doctor visits, medication etc) prior to beginning of the programme, post programme (12 weeks) and three month follow up
Secondary outcome [8] 302297 0
Repeated Sit to Stand (5 repetitions) - Simmonds et al (1998)
Timepoint [8] 302297 0
Pre programme , post programme (12 weeks)

Eligibility
Key inclusion criteria
Individuals aged 18-65 years old,
Have a history of low back pain (LBP) for at least 3 months in duration or recurrent LBP
No red flag pathology
No performance restricting cardio-respiratory disease
Patients are willing to participate in the study.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have acute radicular/nerve root pain
Patients with performance restricting cardio-respiratory disease
Have red flag pathology
Pre-existing neurological condition that limits their capacity to partake in a group exercise intervention
Pregnancy
Unwilling to participate in the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients referred to the Backcare programme, who are suffering from low back pain (pain lasting longer than 6 weeks), will be sent written information regarding the study along with questionnaires to complete before they attend the clinic. On the initial appointment, patients will be assessed as routine care. This includes history taking, a physical examination, review of completed questionnaires, and performance of timed functional outcome measures.
The STarTBack screening tool will be scored and patients divided into one of three groups – Low, Medium or High Risk of persisting symptoms. Following the clinical assessment, if patients are deemed suitable for the treatment intervention, and willing to participate in the study, written consent will be obtained. All questions regarding the study will be answered by the principle investigator prior to consent being obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients are not randomised to treatment protocol, they are stratified based on the outcome of the Startback tool
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size calculations were determined using the RMDQ has been chosen as the primary outcome measure in keeping with prior research. A difference of 2.5 points on the RMDQ is considered to be a minimum clinically important difference (Bombardier et al 2001). As the high risk intervention is the new intervention, our hypothesis will test the superiority of 'targeted treatment' over previous best care for the high risk subgroup. Following statistical review of both the original STarTBack trial (Hill et al 2011) and existing data held by the researcher, a minimum of 52 subjects will be required in the high risk intervention to detect an added effect size of 0.56 over controls, with 80% power and alpha (two-tailed) = 0.05. Equivalence of the stratified treatment model to standard care for medium and low risk groups will be determined if the lower boundary of the 95% CI around the mean difference RMDQ (stratified - standard) does not exceed the MCID of 2.5 (Hill 2011). Thus a minimum of 52 subjects is required for each of the treatment groups.
All data will be cleaned and entered into the Statistical Package for the Social Sciences (SPSS, Version 16). The primary analysis will compare pre to post intervention outcomes for each treatment group to determine if a significant treatment effect is achieved by each of the targeted interventions using paired t tests. The treatment response will then be compared between groups using a mixed ANOVA model with baseline to post intervention as a repeated measure and treatment group as the between group factor. Statistical significance will be set at p<0.05. If the targeted intervention strategy is effective, there should be no significant difference in the magnitude or direction of change between groups.

Recruitment
Recruitment status
Recruiting
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 outside Australia
Country [1] 5010 0
Ireland
State/province [1] 5010 0
Munster

Funding & Sponsors
Funding source category [1] 287082 0
Charities/Societies/Foundations
Name [1] 287082 0
Irish Pain Society (Chapter of the International Association for the Study of Pain)
Address [1] 287082 0
22, Merrion Square, Dublin 2
Country [1] 287082 0
Ireland
Funding source category [2] 287099 0
Commercial sector/Industry
Name [2] 287099 0
Pfizer Healthcare Ireland (Donal Murphy)
Address [2] 287099 0
9 Riverwalk National Digital Park
Citywest Business Campus, Dublin 24
Country [2] 287099 0
Ireland
Primary sponsor type
Individual
Name
Dr Brona Fullen
Address
A310 School of Public Health, Physiotherapy and Population Science
Health Science Centre
University College Dublin
Dublin 4
Country
Ireland
Secondary sponsor category [1] 285857 0
Individual
Name [1] 285857 0
Dr Catherine Blake
Address [1] 285857 0
A102 School of Public Health, Physiotherapy and Population Science
Health Science Centre
University College Dublin
Dublin 4
Country [1] 285857 0
Ireland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289099 0
Waterford Regional Hospital Ethics Committee
Ethics committee address [1] 289099 0
Dunmore Road
Waterford
Co. Waterford
Ethics committee country [1] 289099 0
Ireland
Date submitted for ethics approval [1] 289099 0
Approval date [1] 289099 0
01/02/2012
Ethics approval number [1] 289099 0

Summary
Brief summary
We are carrying out a study on patients with low back pain. We wish to find out whether separating patients into different treatment groups based on their answers to the Startback questionnaire will lead to improved results compared to how patients are currently managed (i.e. usual care), and that it is more cost-effective. Patients will be separated into one of three groups: low, medium or high risk of persisting symptoms and different treatments will be offered to each group. The study hypothesis is that the implementation of targeted treatment protocols in a group setting using the STarTBack Risk Stratification Tool will result in significantly better physical and psychological outcomes in a population of low back pain patients.
The findings should help to improve the management of patients with chronic pain.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 39234 0
Miss Susan Murphy
Address 39234 0
Backcare Programme
Waterford Regional Hospital
Dunmore Road
Waterford
Co Waterford
Country 39234 0
Ireland
Phone 39234 0
+353 51 842124
Fax 39234 0
Email 39234 0
susane.murphy@hse.ie
Contact person for public queries
Name 39235 0
Miss Susan Murphy
Address 39235 0
Backcare Programme
Waterford Regional Hospital
Dunmore Road
Waterford
Co Waterford
Country 39235 0
Ireland
Phone 39235 0
+353 51842124
Fax 39235 0
Email 39235 0
susane.murphy@hse.ie
Contact person for scientific queries
Name 39236 0
Dr Brona Fullen
Address 39236 0
A310 School of Public Health, Physiotherapy and Population Science
Health Science Centre
Belfied Campus
University College Dublin
Dublin 4
Country 39236 0
Ireland
Phone 39236 0
+353 1 7166516
Fax 39236 0
Email 39236 0
brona.fullen@ucd.ie

No information has been provided regarding IPD availability
Summary results
No Results