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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-006196-12-GB
Enrollment
60
Registered
2006-05-05
Start date
2006-06-05
Completion date
Unknown
Last updated
2019-11-25

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

Conditions

Chronic, lumbar back pain.

Interventions

Trade Name: Depo-medrone 40mg/ml Product Name: Depo-medrone 40mg/ml Pharmaceutical Form: Suspension for injection INN or Proposed INN: Methylprednisolon

Sponsors

Nottingham City Hospital NHS Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.—

Countries

United Kingdom

Outcome results

None listed

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