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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14943354

Enrollment

Registered

2006-09-29

Start date

2005-11-11

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower back and leg pain Musculoskeletal Diseases Dorsalgia

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Severity of pain as identified by Visual Analogue Scale (VAS).	—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026