Condition category
Musculoskeletal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/07/2008
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 Jeremy Lewis

ORCID ID

Contact details

Physiotherapy Dept
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0)181 746 8406
jeremy.lewis@chelwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0060055840

Study information

Scientific title

Acronym

Study hypothesis

Experimental hypothesis: A specific exercise protocol will be clinically more beneficial as well as being more cost effective than other forms of treatment for chronic low back pain.

Ethics approval

Not provided at time of registration

Study design

Randomised single-blind placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Musculoskeletal Diseases: Chronic low back pain

Intervention

Eighty patients with chronic low back pain (> 3 months) were randomized to one of the following treatments, involving 8 treatments over 8 weeks:
1. one to one treatment involving 30 minutes of manual therapy (mobilizations to the spine) and spinal stabilization exercises
2. a 10 station exercise class involving aerobic exercises, spinal stabilization exercises and manual therapy.

Three physiotherapists lead the hour long group with a maximum of 10 patients. Questionnaires were completed and physical measurements were taken by a blinded observer before randomization, at the completion of treatment, at 6 months and 12 months after the completion of treatment. The intention to treat principle was used in data analysis.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Prior to July 2008:
Visual analogue scale (pain intensity). Objective measures (lumbar range of movement, straight leg raise, Biering-Sorenson test). Functional test.

Modified July 2008 to:
Quebec back pain disability questionnaire

Secondary outcome measures

Added July 2008:
1. Subjective rating of change
2. Visual analogue scale for pain
3. Perceived level of fitness
4. Analgesic use
5. Number of cigarettes / day
6. Level of confidence relating to back pain
7. Lumbar range of movement
8. Range of straight leg raise

Overall trial start date

01/01/2000

Overall trial end date

01/08/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Added July 2008:
1. Subjects between the ages of 18 to 75 years
2. Fluency in English
3. Mechanical low back pain for more than 3 months (of a non-radicular nature). Mechanical pain was defined as LBP which increased with movement.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 subjects

Participant exclusion criteria

1. Patients with cardiac, respiratory, kidney, blood pressure or blood circulatory problems, spinal surgery, fracture, inflammatory or infectious diseases of the spine, metabolic disease, neurological deficit, rheumatoid arthritis or diabetes
2. Health professionals and staff members at the institution where data was collected
3. Potential subjects who were pregnant or attempting to become pregnant
4. Patients who were not capable of participating in a graded exercise program were also excluded

Recruitment start date

01/01/2000

Recruitment end date

01/08/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physiotherapy Dept
London
SW10 9NH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Chelsea and Westminster Healthcare NHS Trust (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

2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15803071

Publication citations

  1. Results

    Lewis JS, Hewitt JS, Billington L, Cole S, Byng J, Karayiannis S, A randomized clinical trial comparing two physiotherapy interventions for chronic low back pain., Spine, 2005, 30, 7, 711-721.

Additional files

Editorial Notes