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ISRCTN
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ISRCTN53815070
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial (RCT) comparing long term effect of exercise to rehabilitate spinal stabilisation, manual therapy & an education booklet in the treatment of chronic back pain
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Scientific title
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Acronym
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N/A
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Serial number at source
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REC00075
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Study hypothesis
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The number of patients referred to Physiotherapy because of chronic low back pain continues to increase and it is well recognised that the management of these patients creates an increasing burden to the NHS. A growing body of evidence indicates that an active rehabilitation approach to these patients is effective at reducing pain and disability. More recently evidence has emerged that rehabilitating the deep lumbar stabilising muscles may reduce the recurrence rate of low back pain. In contrast, the effectiveness of standard NHS physiotherapy for low back pain has not been established, and whilst 50% of all patients referred to Physiotherapy outpatients have low back pain, to our knowledge there are no pragmatic studies concerned with investigating the effectiveness of this management strategy.
We propose to conduct a randomised control trial to compare the effects of exercises to rehabilitate spinal stabilisation, manual therapy and as a control and minimal treatment condition, an education booklet in the conservative treatment of low back pain.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Spinal conditions
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Participants - inclusion criteria
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Subjects aged between 18-65 years with Chronic Low Back Pain of at least 7 weeks duration will be recruited from the physiotherapy departments in St George's Healthcare.
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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01/09/1997
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Anticipated end date
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01/09/2000
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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346 (added 08/01/10, see publication)
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Interventions
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1. Exercises to rehabilitate spinal stabilisation
2. Manual therapy
3. (Control) minimal treatment condition, an education booklet in the conservative treatment of low back pain
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Primary outcome measure(s)
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1. Pain (0-100 numerical rating scale for back pain intensity, 0-100 scale for leg pain intensity, The Pain Diagram)
2. Impairment (Shuttle walking test, modified Schober technique for range of lumbar flexion)
3. Disability (Revised Oswestry Pain Questionnaire, The Low Back Outcome Score)
4. Handicap (Low Back Outcome Score: Return to work/work status/sick leave)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16648741
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Contact name
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Ms
Lucy
Goldby
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Address
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St George's Healthcare NHS Trust
St George's Hospital Physiotherapy
Blackshaw Road
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Email
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lucy@balancephysio.com
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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08/01/2010
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Date ISRCTN assigned
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23/01/2004
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