A comparison of the effectiveness of three physiotherapy regimes commonly used to reduce disability in patients with chronic low back pain

ISRCTN ISRCTN56323917
DOI https://doi.org/10.1186/ISRCTN56323917
Secondary identifying numbers C0647
Submission date
10/07/2002
Registration date
10/07/2002
Last edited
06/01/2011
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Duncan Critchley
Scientific

Applied Biomedical Science Research Group
King's College London
Guy's Campus
London
SE1 1UL
United Kingdom

+44 (0)20 7836 5454
duncan.critchley@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesChronic 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.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedChronic low back pain
Intervention1. Individual physiotherapy
2. Group functional restoration programme
3. Group spinal stabilisation training
Intervention typeOther
Primary outcome measureRoland Morris Disability Questionaire
Secondary outcome measures1. 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)
Overall study start date01/01/2002
Completion date01/02/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants212
Key inclusion criteriaNon-specific lower back pain of 3/12 duration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2002
Date of final enrolment01/02/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Applied Biomedical Science Research Group
London
SE1 1UL
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom

+44 (0)300 790 0400
enquiries@arthritisresearchuk.org
http://www.arc.org.uk
ROR logo https://ror.org/02jkpm469

Funders

Funder type

Charity

Arthritis Research Campaign (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 15/06/2007 Yes No
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