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ISRCTN
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ISRCTN56323917
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ClinicalTrials.gov identifier
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Public title
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A comparison of the effectiveness of three physiotherapy regimes commonly used to reduce disability in patients with chronic low 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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C0647
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Study hypothesis
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Chronic low-back pain has enormous personal and socio-economic costs locally, nationally and internationally. However, diagnosis is difficult and treatment controversial. Many forms of Physiotherapy are advocated including: individual manipulative treatment, group exercises aiming to restore the protective function of supposedly dysfunctional deep trunk muscles or group exercises aiming to reduce psychological distress and fear of movement. All three treatments can reduce pain and disability but it is not known if one treatment is more effective or cost-effective. Nor is it known if treatment success is related to the proposed mechanism, such as change of muscle function. We will compare these three treatments whilst measuring some of the factors they propose to change.
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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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Chronic low back pain
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Participants - inclusion criteria
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Non-specific lower back pain of 3/12 duration
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2002
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Anticipated end date
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01/02/2005
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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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212
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Interventions
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1. Individual physiotherapy
2. Group functional restoration programme
3. Group spinal stabilisation training
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Primary outcome measure(s)
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Roland Morris Disability Questionaire
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Secondary outcome measure(s)
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1. Pain (Numerical Analogue Scale)
2. Health-related quality of life (EQ-5D)
3. Work status and other economic effects of back-pain (Client Service Receipt Inventory [CSRI])
4. Patient satisfaction with outcome and satisfaction with treatment (7-point descriptive scale)
5. Emotional distress (28-item General Health Questionnaire [GHQ-28])
6. Fear-avoidance (Tampa scale of kinesiophobia)
7. Coping strategies (Coping Strategies Questionnaire [CSQ])
8. Transversus abdominis, obliquus internus, obliquus externus thickness (real-time ultrasound)
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Sources of funding
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Arthritis Research Campaign (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/pubmed/17572614
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Contact name
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Dr
Duncan
Critchley
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Address
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Applied Biomedical Science Research Group
King's College London
Guy's Campus
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City/town
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London
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Zip/Postcode
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SE1 1UL
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Country
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United Kingdom
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Tel
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+44 (0)20 7836 5454
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Email
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duncan.critchley@kcl.ac.uk
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Sponsor
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Arthritis Research Campaign (ARC) (UK)
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Address
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Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
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City/town
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Derbyshire
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Zip/Postcode
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S41 7TD
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Country
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United Kingdom
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Email
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info@arc.org.uk
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Sponsor website:
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http://www.arc.org.uk
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Date applied
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10/07/2002
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Last edited
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11/04/2008
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Date ISRCTN assigned
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10/07/2002
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