Condition category
Musculoskeletal Diseases
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/10/2014
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 R Langford

ORCID ID

Contact details

Pain Research Group
Anaesthetic Laboratory
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
+44 (0)20 7601 7524

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0205172997

Study information

Scientific title

Acronym

Study hypothesis

To establish if there is any acute analgesic effect of anti-tumour necrotising factor (TNF) treatment in patients with lower back and leg pain.

Ethics approval

Not provided at time of registration

Study design

Prospective single-centre randomised double-blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Lower back and leg pain

Intervention

Patients are randomised to:
1. One week treatment with anti-tumour necrotising factor (TNF)
2. One week treatment with placebo

Intervention type

Drug

Phase

Not Applicable

Drug names

Anti-TNF

Primary outcome measures

Severity of pain as identified by Visual Analogue Scale (VAS).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

11/11/2005

Overall trial end date

10/05/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients must be willing and able to give written informed consent prior to admission to the study
2. Patients must be American Society of Anesthesiologists (ASA) grade I - III
3. Patients must be aged 18 - 65 years
4. Patients must be scheduled to undergo epidural steroid injection (ESI) for lower back pain of more than one month's duration and up to nine months
5. Patients must have had a chest X-ray prior to admission to the study, within the last six months
6. Females of the childbearing age must have a negative urine pregnancy test on the day of the study, and be using an acceptable method of contraception

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

Participant exclusion criteria

1. A history of diabetes mellitus
2. A history of uncontrolled chronic disease
3. Evidence of immunosupression (including current steroid treatment), immunodeficiency or human immunodeficiency virus (HIV) positive status
4. History of tuberculosis (TB)
5. Pain for less than one month or more than nine months duration
6. Previous back surgery
7. Previous chronic pain interventions
8. Presence of any of the following:
8.1. Recent bowel or bladder disturbance
8.2. Motor deficit
8.3. Saddle anaesthesia
8.4. Suspected malignancy (primary or secondary)
9. Any other back pain 'red flag' symptoms and signs, identified by the patient's clinicians or the study investigators
10. A history of spinal or neurological disease
11. A history of congestive cardiac failure
12. Known hypersensitivity to anti-TNF
13. A history of previous administration of anti-TNF
14. Any contraindications to anti-TNF in the Summary of Product Characteristics
15. Pregnancy or lactation
16. Patients who are unwilling or unable to conform to the protocol

Recruitment start date

11/11/2005

Recruitment end date

10/05/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Pain Research Group
London
EC1A 7BE
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - 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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Barts and The London NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Queen Mary University of London (QMUL) (UK)

Alternative name(s)

QMUL

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Funder name

NHS R&D Support Funding (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