Condition category
Musculoskeletal Diseases
Date applied
16/07/2002
Date assigned
16/07/2002
Last edited
04/10/2007
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 Helen Frost

ORCID ID

Contact details

Faculty of Health Sciences
Physiotherapy Department
Queen Margaret University College
Duke Street
Leith
Edinburgh
EH6 8HF
United Kingdom
+44 (0)131 317 3654
hfrost@qmuc.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

F0519

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

Scores on the Oswestry disability index at 12 months: 0% (no disability) to 100% (totally disabled or bed ridden).

Secondary outcome measures

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)

Overall trial start date

01/10/1997

Overall trial end date

01/01/2001

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

286

Participant 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

Recruitment start date

01/10/1997

Recruitment end date

01/01/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Faculty of Health Sciences
Edinburgh
EH6 8HF
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15377573

Publication citations

  1. Results

    Frost H, Lamb SE, Doll HA, Carver PT, Stewart-Brown S, Randomised controlled trial of physiotherapy compared with advice for low back pain., BMJ, 2004, 329, 7468, 708, doi: 10.1136/bmj.38216.868808.7C.

Additional files

Editorial Notes