Status:
COMPLETED
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Lead Sponsor:
Medical University of Vienna
Conditions:
Chronic Low Back Pain
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Objective: The objective of this study is to compare the efficacy of duloxetine in the treatment of patients with chronic low back pain with a radicular component to placebo. Study hypothesis: Dulo...
Eligibility Criteria
Inclusion
- Low back pain ( below L1)
- Chronic pain, \>6 months
- Visual Analogue Scale (VAS) ≥ 5
- Back pain with radicular component defined as pain with a burning, tingling sensation within the anatomic distribution of the nerve root and diagnosed by painDETECT questionnaire
- Failed back surgery
Exclusion
- Current mood disorder (dysthymia, bipolar mood disorder)
- Major Depression \> 12 months (Beck Depression Inventory Score ≥ 18)
- History of a psychoactive substance use disorder within the preceding 12 months
- Major coexisting medical illness (e.g. severe heart failure, pulmonary hypertension, renal insufficiency)
- Glaucoma
- Acute myocardial infarction
- uncontrolled hypertension
- Prostate hyperplasia
- History of convulsion
- Pregnancy; women of childbearing age will be required to use contraceptives during the duration of the study. Furthermore a pregnancy test will be performed prior to the beginning of the study and once a month during the study period.
- Participation in a clinical trial in the 3 weeks preceding the study
- Allergy to study medication
- Use of the following medication:
- opioids except for tramadol,
- benzodiazepines other than indicated at low doses for sleep disorders
- antineuropathic medication including except for that specified in the study protocol
- muscle relaxants
- antidepressants other than indicated at low doses for sleep disorders
- NSAID, Paracetamol
- non-selective MAO-Inhibitors
- Fluvoxamine, Ciprofloxacin, Enoxacin
- Selective Serotonin-reuptake Inhibitors (SSRI)
- if tapering of these drugs is impossible before inclusion.
- Impaired kidney function (Creatinine \> 1.5mg/dl)
- Impaired hepatic function (GOT, GPT \>2 fold standard levels)
- Patients who are not able to understand the study measures and are not able to complete pain assessment forms.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01166048
Start Date
May 1 2010
End Date
June 1 2014
Last Update
July 31 2014
Active Locations (1)
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1
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna
Vienna, Vienna, Austria, 1090