Effectiveness of Clonidine for the treatment of sciatica: A randomized, double-blind and prospective study. (EFFOC study)

Conditions: Radicular lumbar pain
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-003560-74-NL

Lead Sponsor: eiden University Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients with lumbar radicular pain and NRS > 4 for longer than 6 weeks
MRI evidence of a herniated disc

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Obesity (BMI > 40)
Coagulopathy
Use of anticoagulation
Systemic or local infection
Allergy to local anesthetics, clonidine or steroids
Legal claims or workman’s compensation
Pregnancy
FBSS
Transforaminal epidural steroid injections or (pulsed) radiofrequency treatment at lumbar nerve roots within one year before inclusion in the study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1)To study the effect of Clonidine on lumbar radicular pain with a transforaminal epidural injection after 1 week, 1, 3 and 6 months using a BPI.;Secondary Objective: 2)To study the effect of Clonidine on lumbar radicular pain with a transforaminal epidural injection after 1 week, 1, 3 and 6 months using the Ostwestry index;Primary end point(s): 1. Brief Pain Inventory (BPI)<br>2. Ostwestry Disability Questionnaire <br>;Timepoint(s) of evaluation of this end point: 1 hour post-intervention<br>1 week post-intervention<br>1 month post-intervention<br>3 months post-intervention<br>6 months post-intervention<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Ostwestry Index;Timepoint(s) of evaluation of this end point: 1 hour post-intervention<br>1 week post-intervention<br>1 month post-intervention<br>3 moonths post-intervention<br>6 months post-intervention