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
Protocol serial number	C0647
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

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

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Chronic low back pain
Intervention	1. Individual physiotherapy 2. Group functional restoration programme 3. Group spinal stabilisation training
Intervention type	Other
Primary outcome measure(s)	Roland Morris Disability Questionaire
Key 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)
Completion date	01/02/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	212
Key inclusion criteria	Non-specific lower back pain of 3/12 duration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	01/02/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Applied Biomedical Science Research Group

London
SE1 1UL
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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