Condition category
Musculoskeletal Diseases
Date applied
23/11/2006
Date assigned
05/01/2007
Last edited
08/10/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Elizabeth E J Mason

ORCID ID

Contact details

Keele University
Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
+44 (0)1782 583900
e.mason@cphc.keele.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17741

Study information

Scientific title

Acronym

STarT Back

Study hypothesis

1. Patients at low risk can be managed effectively with a brief intervention and will remain at low risk subsequently.
2. Patients at high risk who are managed within a framework that targets modifiable physical and psychosocial risk factors will have reduced risk of future disabling chronic back pain.

Ethics approval

Approval received from the North Staffordshire LREC in February 2007 (ref: 07/Q2604/5).

Study design

Pragmatic randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Low back pain

Intervention

1. Targeted treatment arm:
The new intervention to be tested in this trial is “targeted treatment”, which will be allocated according to the sub-grouping tool, and administered on a stepped-care basis. As described above, all patients randomised to this treatment arm will be seen on their first visit to the Community Back Pain Clinic by a study physiotherapist who will provide an initial 30-minute standard intervention and inform them of their treatment plan according to the results of the screening tool. Treatment allocation will be as follows:
a. Group one (low risk): ‘Initial 30-minute physiotherapy intervention’ alone
b. Group two (medium risk): ‘Initial 30-minute physiotherapy intervention’ plus ‘medium risk group’ intervention
c. Group three (high risk): ‘Initial 30-minute physiotherapy intervention’ plus ‘high risk group’ intervention

2. Non targeted treatment:
Current best practice physiotherapy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Roland Morris Disability Questionnaire
2. Pain Catastrophising Scale

Secondary outcome measures

1. Recurrence of back pain
2. Fear avoidance (Tampa Scale of Kinesiophobia)
3. Back pain bothersomeness
4. Anxiety and depression (Hospital Anxiety and Depression Scale)
5. Self-reported global change in back problem
6. Pain intensity
7. Patient perceptions of their low back pain
8. Patient satisfaction
9. Overall health status (EuroQol instrument [EQ5D], Short Form health survey version two [SF12 vs2])

Overall trial start date

01/04/2007

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Males and females age 18 and over with non-specific low back pain
2. Able to give informed and written consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Persons with “red flags” indicative of possible serious spinal pathology
2. Serious co-morbidity
3. Psychiatric illness/personality disorder
4. Recent spinal surgery (less than six months)
5. Pregnancy
6. Already receiving treatment for this episode of back pain

Recruitment start date

01/04/2007

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Keele University
Newcastle-Under-Lyme
ST5 5BG
United Kingdom

Sponsor information

Organisation

Keele University (UK)

Sponsor details

Keele
Newcastle-Under-Lyme
ST5 5BG
United Kingdom
e.mason@cphc.keele.ac.uk

Sponsor type

University/education

Website

http://www.keele.ac.uk/

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (project grant 17741) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18430242
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21963002
3. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22507360
4. 2012 cost-utility results in http://www.ncbi.nlm.nih.gov/pubmed/22492783

Publication citations

  1. Results

    Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM, Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial., Lancet, 2011, 378, 9802, 1560-1571, doi: 10.1016/S0140-6736(11)60937-9.

  2. Results

    Main CJ, Sowden G, Hill JC, Watson PJ, Hay EM, Integrating physical and psychological approaches to treatment in low back pain: the development and content of the STarT Back trial's 'high-risk' intervention (StarT Back; ISRCTN 37113406)., Physiotherapy, 2012, 98, 2, 110-116, doi: 10.1016/j.physio.2011.03.003.

  3. Hay EM, Dunn KM, Hill JC, Lewis M, Mason EE, Konstantinou K, Sowden G, Somerville S, Vohora K, Whitehurst D, Main CJ, A randomised clinical trial of subgrouping and targeted treatment for low back pain compared with best current care. The STarT Back Trial Study Protocol., BMC Musculoskelet Disord, 2008, 9, 58, doi: 10.1186/1471-2474-9-58.

  4. Whitehurst DG, Bryan S, Lewis M, Hill J, Hay EM, Exploring the cost-utility of stratified primary care management for low back pain compared with current best practice within risk-defined subgroups., Ann. Rheum. Dis., 2012, 71, 11, 1796-1802, doi: 10.1136/annrheumdis-2011-200731.

Additional files

Editorial Notes