The efficacy of exercises for the treatment of chronic low back pain.

ISRCTN	ISRCTN12458386
DOI	https://doi.org/10.1186/ISRCTN12458386
Protocol serial number	N0060055840
Sponsor	Department of Health
Funder	Chelsea and Westminster Healthcare NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 16/07/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeremy Lewis
Scientific

Physiotherapy Dept
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom

Phone	+44 (0)181 746 8406
Email	jeremy.lewis@chelwest.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised single-blind placebo-controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/08/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	80
Key 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.
Key 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
Date of first enrolment	01/01/2000
Date of final enrolment	01/08/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Physiotherapy Dept

London
SW10 9NH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/04/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes