A prospective, single-centre, randomised, double-blind, placebo-controlled trial to assess the analgesic effects of one-week treatment with anti-tumour necrotising factor (TNF) in patients with lower back and leg pain
| ISRCTN | ISRCTN14943354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14943354 |
| Secondary identifying numbers | N0205172997 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 07/10/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof R Langford
Scientific
Scientific
Pain Research Group
Anaesthetic Laboratory
St Bartholomew's Hospital
West Smithfield
London
EC1A 7BE
United Kingdom
| Phone | +44 (0)20 7601 7524 |
|---|
Study information
| Study design | Prospective single-centre randomised double-blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Anti-TNF |
| Primary outcome measure | Severity of pain as identified by Visual Analogue Scale (VAS). |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 11/11/2005 |
| Completion date | 10/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 11/11/2005 |
| Date of final enrolment | 10/05/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Pain Research Group
London
EC1A 7BE
United Kingdom
EC1A 7BE
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Barts and The London NHS Trust (UK)
No information available
Queen Mary University of London (QMUL) (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- QMUL
- Location
- United Kingdom
NHS R&D Support Funding (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
