Evaluation of the Oxfordshire Physiotherapy Service for patients with low back pain: a multicentre randomised controlled trial

ISRCTN	ISRCTN41782781
DOI	https://doi.org/10.1186/ISRCTN41782781
Protocol serial number	F0519
Sponsor	Arthritis Research Campaign (ARC) (UK)
Funder	Arthritis Research Campaign (UK)

Submission date: 16/07/2002
Registration date: 16/07/2002
Last edited: 04/10/2007

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 Helen Frost
Scientific

Faculty of Health Sciences
Physiotherapy Department
Queen Margaret University College
Duke Street
Leith
Edinburgh
EH6 8HF
United Kingdom

Phone	+44 (0)131 317 3654
Email	hfrost@qmuc.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To measure the effectiveness of routine physiotherapy compared with an assessment session and advice from a physiotherapist for patients with low back pain.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Low back pain
Intervention	Group 1: Advice group - This group will have a single contact with a physiotherapist who will offer self management advice as specified in the advice booklet (see below). Specific exercises will not be advised. Group 2: Routine physiotherapy treatment - The physiotherapists will decide on the content of treatment according to their assessment. Treatment will be restricted to a combination of the following techniques depending on the physiotherapists' clinical judgment: 1. Mobilisation techniques including manipulation 2. Soft tissue techniques 3. Individual exercise programmes 4. Heat or cold treatment. No electrotherapy or traction will be used. Trial participants will receive a maximum of six treatment sessions. Information will be recorded on the type of physiotherapy intervention and the level of training and clinical experience of the physiotherapist. Advice booklet: Patients in group 1 and group 2 will be given a standardised advice booklet that has been produced by a group of experts in the field of low back pain. The advice in the booklet will be explained by the physiotherapist in a session lasting up to 1 hour. It will encourage activity and discourage bed rest.
Intervention type	Other
Primary outcome measure(s)	Scores on the Oswestry disability index at 12 months: 0% (no disability) to 100% (totally disabled or bed ridden).
Key secondary outcome measure(s)	1. Scores on the Oswestry disability index at two and six months 2. Scores on the Roland and Morris disability questionnaire at 2, 6, and 12 months 3. General health was measured with the 36-item Short Form health survey (SF-36) at 2, 6, and 12 months (higher scores indicate better health) 4. Patient perceived benefit of treatment was measured on a scale from 0 (no benefit) to 10 (maximum benefit) and on a dichotomous scale (perceived benefit or no perceived benefit)
Completion date	01/01/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	286
Key inclusion criteria	1. Aged 18+ years 2. Subacute (more than 6 weeks less than 3 months) or chronic (more than 3 months) mechanical low back pain 3. With or without leg pain or neurological signs
Key exclusion criteria	1. Patients with serious conditions including: 1.1. Systemic rheumatological disease 1.2. Gynaecological problems 1.3. Ankylosing spondylitis 1.4. Tumours 1.5. Infection 2. Past spinal operations 3. Treatment for physical problems in the past month 4. Referred for intensive functional restoration programmes
Date of first enrolment	01/10/1997
Date of final enrolment	01/01/2001

Locations

Countries of recruitment

United Kingdom
Scotland

Study participating centre

Faculty of Health Sciences

Edinburgh
EH6 8HF
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	25/09/2004		Yes	No