A prospective, single centre, randomised, double-blind, placebo controlled trial to assess the analgesic effects of one week treatment with anti-TNF in patients with lower back and leg pain. - Pilot study of anti-TNF use in lower back and leg pain patientsw
- Conditions
- ower back and leg pain
- Registration Number
- EUCTR2005-003722-26-GB
- Lead Sponsor
- Barts and the London NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
A potential participant must be willing and able to give written informed consent prior to admission to the study.
Participant must be ASA I-III.
Participant must be aged 18-65
Participant must be deemed suitable to be scheduled for an epidural steroid injection for lower back and leg pain of more than one month's duration and up to nine months.
Participant must have a chest X-ray prior to admission to the study, within the last six months (to exclude TB and malignancy)
Females of childbearing age must have a negative urine pregnancy test on the day of the study and must be using an acceptable method of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
A history of diabetes mellitus
A history of uncontrolled chronic disease
Evidence of immunosupression (including current steroid treatment, immunodeficiency or HIV positive status)
A history of TB
Pain less than a month or more than nine months duration
Previous back surgery
Previous chronic pain interventions
Presence of any of the following: 1) recent bowel or bladder disturbance, 2) motor deficit, 3) saddle anaesthesia, 4) suspected malignancy (primary or secondary)
A history of spinal or neurological disease
A history of congestive heart failure
Known hypersensitivity to anit-TNF (Enbrel)
Any contraindications to anti-TNF (Enbrel) in the Summary of Product Characteristics
Pregnancy or lactation
Patients who are unwilling or unable to conform to the protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the trial is to establish if there is any acute analgesic effect of anti-TNF (Enbrel) treatment in patients with lower back and leg pain. ;Secondary Objective: To demonstrate the time to onset, duration of effect and magnitude of analgesic response.<br>To demonstrate improvement in dynamic pain measurements.<br>To demonstrate improvement in disability score.<br>To establish if there is a link between pre-intervention blood levels of CRP and the magnitude of response to anti-TNF treatment.;Primary end point(s): Severity of pain as identified by VAS (visual analogue scale).
- Secondary Outcome Measures
Name Time Method