Contact information
Type
Scientific
Primary contact
Prof Kim Burton
ORCID ID
Contact details
Spinal Research Unit
30 Queen Street
Huddersfield
HD1 2SP
United Kingdom
+44 (0)1484 535200
kim@spineresearch.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ND0020 T367 Burton R&D
Study information
Scientific title
Acronym
Study hypothesis
The purpose of this study is to compare the effects of two treatment modalities available for lumbar disc herniation. The principle aim of the project is to ascertain which, if either, treatment is superior in terms of reducing symptoms/disability, and the relative cost effectiveness/patient satisfaction. The treatments to be studied are chemonucleolysis and osteopathic manipulation. Despite the choice of a well defined low back pathology for this trial, it may be that some 'types' of patient respond better to one or other of the treatments; strenuous attempts will be made to identify any such categories. The benefits to the NHS will be the determination of the more cost-effective treatment for this condition. Should the result favour manipulation, there will be the potential for reduction both of therapeutic costs and of orthopaedic waiting lists.
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
Lumbar disc herniation
Intervention
1. Chemonucleolysis
2. Osteopathic manipulation
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Symptoms/disability and the relative cost effectiveness/patient satisfaction.
2. Pain (back and leg) and disability
Secondary outcome measures
Therapeutic failure
Overall trial start date
02/01/1994
Overall trial end date
31/12/1998
Reason abandoned
Eligibility
Participant inclusion criteria
Patients with lumbar disc herniation
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
40
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
02/01/1994
Recruitment end date
31/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Spinal Research Unit
Huddersfield
HD1 2SP
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 Northern and Yorkshire (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
Results in http://www.ncbi.nlm.nih.gov/pubmed/10905437
Publication citations
-
Results
Burton AK, Tillotson KM, Cleary J, Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation., Eur Spine J, 2000, 9, 3, 202-207.