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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=retrieve&db=pubmed&list_uids=15377573
Publication citations
-
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.