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 pai

Completed

• Conditions: ower back and leg pain; Musculoskeletal Diseases; Dorsalgia

• Registration Number: ISRCTN14943354
• Lead Sponsor: Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09-29
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified