Condition category
Musculoskeletal Diseases
Date applied
10/07/2002
Date assigned
10/07/2002
Last edited
06/01/2011
Prospective/Retrospective
Retrospectively 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

Dr Duncan Critchley

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

C0647

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Chronic low back pain

Intervention

1. Individual physiotherapy
2. Group functional restoration programme
3. Group spinal stabilisation training

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Roland Morris Disability Questionaire

Secondary outcome measures

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)

Overall trial start date

01/01/2002

Overall trial end date

01/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Non-specific lower back pain of 3/12 duration

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

212

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2002

Recruitment end date

01/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Applied Biomedical Science Research Group
London
SE1 1UL
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Gate
Chesterfield
S41 7TD
United Kingdom
+44 (0)300 790 0400
enquiries@arthritisresearchuk.org

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17572614

Publication citations

  1. Results

    Critchley DJ, Ratcliffe J, Noonan S, Jones RH, Hurley MV, Effectiveness and cost-effectiveness of three types of physiotherapy used to reduce chronic low back pain disability: a pragmatic randomized trial with economic evaluation., Spine, 2007, 32, 14, 1474-1481, doi: 10.1097/BRS.0b013e318067dc26.

Additional files

Editorial Notes