Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
08/01/2010
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes