Contact information
Type
Scientific
Primary contact
Ms Lucy Goldby
ORCID ID
Contact details
St George's Healthcare NHS Trust
St George's Hospital Physiotherapy
Blackshaw Road
London
SW17 0QT
United Kingdom
lucy@balancephysio.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00075
Study information
Scientific title
Acronym
Study hypothesis
The number of patients referred to Physiotherapy because of chronic low back pain continues to increase and it is well recognised that the management of these patients creates an increasing burden to the NHS. A growing body of evidence indicates that an active rehabilitation approach to these patients is effective at reducing pain and disability. More recently evidence has emerged that rehabilitating the deep lumbar stabilising muscles may reduce the recurrence rate of low back pain. In contrast, the effectiveness of standard NHS physiotherapy for low back pain has not been established, and whilst 50% of all patients referred to Physiotherapy outpatients have low back pain, to our knowledge there are no pragmatic studies concerned with investigating the effectiveness of this management strategy.
We propose to conduct a randomised control trial to compare the effects of exercises to rehabilitate spinal stabilisation, manual therapy and as a control and minimal treatment condition, an education booklet in the conservative treatment of 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
Treatment
Patient information sheet
Condition
Spinal conditions
Intervention
1. Exercises to rehabilitate spinal stabilisation
2. Manual therapy
3. (Control) minimal treatment condition, an education booklet in the conservative treatment of low back pain
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Pain (0-100 numerical rating scale for back pain intensity, 0-100 scale for leg pain intensity, The Pain Diagram)
2. Impairment (Shuttle walking test, modified Schober technique for range of lumbar flexion)
3. Disability (Revised Oswestry Pain Questionnaire, The Low Back Outcome Score)
4. Handicap (Low Back Outcome Score: Return to work/work status/sick leave)
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1997
Overall trial end date
01/09/2000
Reason abandoned
Eligibility
Participant inclusion criteria
Subjects aged between 18-65 years with Chronic Low Back Pain of at least 7 weeks duration will be recruited from the physiotherapy departments in St George's Healthcare.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
346 (added 08/01/10, see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/1997
Recruitment end date
01/09/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's Healthcare NHS Trust
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive London (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
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16648741
Publication citations
-
Results
Goldby LJ, Moore AP, Doust J, Trew ME, A randomized controlled trial investigating the efficiency of musculoskeletal physiotherapy on chronic low back disorder., Spine, 2006, 31, 10, 1083-1093, doi: 10.1097/01.brs.0000216464.37504.64.