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
Secondary identifying numbers F0519
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

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Scientific title
Study objectivesTo 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) studiedLow back pain
InterventionGroup 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 typeOther
Primary outcome measureScores on the Oswestry disability index at 12 months: 0% (no disability) to 100% (totally disabled or bed ridden).
Secondary outcome measures1. 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)
Overall study start date01/10/1997
Completion date01/01/2001

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants286
Key inclusion criteria1. 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 criteria1. 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 enrolment01/10/1997
Date of final enrolment01/01/2001

Locations

Countries of recruitment

  • Scotland
  • United Kingdom

Study participating centre

Faculty of Health Sciences
Edinburgh
EH6 8HF
United Kingdom

Sponsor information

Arthritis Research Campaign (ARC) (UK)
Charity

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

Email info@arc.org.uk
Website http://www.arc.org.uk
ROR logo "ROR" 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 25/09/2004 Yes No