Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
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

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes