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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
DOI 10.1186/ISRCTN56323917
ClinicalTrials.gov identifier
EudraCT number
Public title A comparison of the effectiveness of three physiotherapy regimes commonly used to reduce disability in patients with chronic low back pain
Scientific title
Acronym N/A
Serial number at source C0647
Study hypothesis 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.
Lay summary
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Chronic low back pain
Participants - inclusion criteria Non-specific lower back pain of 3/12 duration
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/01/2002
Anticipated end date 01/02/2005
Status of trial Completed
Patient information material
Target number of participants 212
Interventions 1. Individual physiotherapy
2. Group functional restoration programme
3. Group spinal stabilisation training
Primary outcome measure(s) Roland Morris Disability Questionaire
Secondary outcome measure(s) 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)
Sources of funding Arthritis Research Campaign (UK)
Trial website
Publications 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17572614
Contact name Dr  Duncan  Critchley
  Address Applied Biomedical Science Research Group
King's College London
Guy's Campus
  City/town London
  Zip/Postcode SE1 1UL
  Country United Kingdom
  Tel +44 (0)20 7836 5454
  Email duncan.critchley@kcl.ac.uk
Sponsor Arthritis Research Campaign (ARC) (UK)
  Address Copeman House
St Mary's Gate
  City/town Chesterfield
  Zip/Postcode S41 7TD
  Country United Kingdom
  Tel +44 (0)300 790 0400
  Fax +44 (0)300 790 0401
  Email enquiries@arthritisresearchuk.org
  Sponsor website: http://www.arc.org.uk
Date applied 10/07/2002
Last edited 06/01/2011
Date ISRCTN assigned 10/07/2002
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