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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

Management of patients with low back pain using targeted treatment based on the Startback tool to assess changes in disability (Roland Morris Disability Questionnaire)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000431729
Acronym
Nil
Enrollment
156
Registered
2013-04-16
Start date
2012-07-03
Completion date
2013-10-27
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

Dr Brona Fullen
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

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.

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

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 22, 2026