A comparison of two diluents commonly used in epidural steroid injection for the treatment of low back pain and sciatica - randomised prospective comparison of diluents used for epidural steroid injection for back pai

Phase 1

• Conditions: ow back pain and sciatica; MedDRA version: 9.1 Level: LLT Classification code 10003989 Term: Back pain (with radiation)

• Registration Number: EUCTR2006-006583-35-GB
• Lead Sponsor: Shrewsbury & Telford Hospital NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-01-22
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

patients with low back pain/sciatica of less than one year duration age 20-75 years scheduled for epidural injection.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unfit for an epidural injection of steroid with local anaesthetic.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of epidural injection with a standard dose of steroid in equal volume of either saline or ropivicaine in the relief of symptoms from low back pain/sciatica;Secondary Objective: ;Primary end point(s): Measurement of Oswestry 2.0 pain score at three months.