E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Radicular lumbar pain |
Radiculaire lumbale pijn |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
1) Op basis van een BPI wordt de effect van Clonidine op lumbale radiculaire pijn bestudeer, die bij een transforaminale epidurale steroid injectie bijgevoegd wordt na 1 weel, 1, 3 en 6 maanden |
|
E.2.2 | Secondary objectives of the trial |
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 |
2) Op basis van een Ostwestry Index wordt de effect van Clonidine op lumbale radiculaire pijn bestudeer, die bij een transforaminale epidurale steroid injectie bijgevoegd wordt na 1 weel, 1, 3 en 6 maanden |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with lumbar radicular pain and NRS > 4 for longer than 6 weeks
MRI evidence of a herniated disc
|
Patienten met radiculaire pijn in hun benen voor langer dan 6 weken
Tekenen van een HNP op het MRI |
|
E.4 | Principal 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
|
Obesitas (BMI meer dan 40)
Storing van de stolling
Gebruik van antistollende middelen
Lokale of systemische infectie
Allergie tegen lokaal anesthetica, clonidine of steroiden
Uitkeuring voor pijn
Zwangerschap
FBSS
Een epidurale transforaminale steroid injectie of een PRF behandeling van de dorsal root ganglion binnen een jaar voor inclusie in de studie |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Brief Pain Inventory (BPI)
2. Ostwestry Disability Questionnaire
|
. Brief Pain Inventory (BPI)
2. Ostwestry Disability Questionnaire
Direct Pre-intervention
1 uur post-intervention
1 week post-intervention
1 maand post-intervention
3 maand post-intervention
6 maand post-intervention
|
|
E.5.1.1 | 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
|
1 uur post-intervention
1 week post-intervention
1 maand post-intervention
3 maand post-intervention
6 maand post-intervention
|
|
E.5.2 | Secondary end point(s) |
Ostwestry Index |
Ostwestry Index |
|
E.5.2.1 | 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 |
1 uur post-intervention
1 week post-intervention
1 maand post-intervention
3 maand post-intervention
6 maand post-intervention
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standaard therapie |
Standard therapy |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Trial ends 6 months after the last treatment of a patient |
Onderzoek stoppt 6 maanden na behandeling van de laatste patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |