Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
25/05/2016
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

Mr John Williamson

ORCID ID

Contact details

Consultant Spinal Surgeon
Hope Hospital
Scott Lane
Salford
M6 8HD
United Kingdom
+44 (0)161 787 4882
bwilliam@fs1.ho.man.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/09/10

Study information

Scientific title

What is the place of surgery in the management of patients with low back and radicular pain?

Acronym

Study hypothesis

A controlled study of spinal fusion against conservative treatment for back problems.

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

Low back pain, sciatica

Intervention

Surgical technique vs conservative management

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Outcome will be measured using both generic and condition specific indicators.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/1997

Overall trial end date

31/08/2002

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with low back pain and sciatica

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/1997

Recruitment end date

31/08/2002

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Consultant Spinal Surgeon
Salford
M6 8HD
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (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

Publication citations

Additional files

Editorial Notes

25/05/2016: No publications found, study status unverified