Epidural steroid injection in chronic, lumbar back pain; a cross-over, single-blinded study of Methyl-prednisolone 80mg versus Methyl-prednisolone 40mg. - Effect of epidural steroid dose on low back disability scores. v4
- Conditions
- Chronic, lumbar back pain.
- Registration Number
- EUCTR2005-006196-12-GB
- Lead Sponsor
- ottingham City Hospital NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
Patients attending for repeat epidural steroid injection, i.e. at least 3 injections in the past 12 months, as part of their chronic pain management programme. These are patients who derive benefit from the treatment.
Oswestry Low Back Pain Disability Index score > 20, i.e. moderate and above disability.
Visual analogue score for pain > 30, i.e. moderate and above pain scores.
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) yes
F.1.3.1 Number of subjects for this age range
Bleeding disorder; this is a standard contra-indication to epidural injection.
Anti-coagulant intake; this is a standard contra-indication to epidural injection.
Local or systemic sepsis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Does 40mg of epidural methylprednisolone produce an equivalent improvement in disability scores compared with 80mg epidural methylprednisolone when given to patients with chronic, lumbar back pain.;Secondary Objective: NIL;Primary end point(s): Oswestry Low Back Pain Disability Index score at 6 weeks after epidural injection.
- Secondary Outcome Measures
Name Time Method