Radicular lumbar pain
Conditions
Interventions
Trade Name: Catapresan
Product Name: Clonidine
Product Code: RVG 06055
Pharmaceutical Form: Injection
Sponsors
Leiden University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 2. Ostwestry Disability Questionnaire ;Timepoint(s) of evaluation of this end point: 1 hour post-intervention 1 week post-intervention 1 month post-intervention 3 months post-intervention 6 months post-intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Ostwestry Index;Timepoint(s) of evaluation of this end point: 1 hour post-intervention 1 week post-intervention 1 month post-intervention 3 moonths post-intervention 6 months post-intervention | — |
Countries
Netherlands
Contacts
Public ContactPain Center
Pain Center Leiden University Medical Center
Outcome results
None listed