Randomized Double-blind Study Comparing the Efficacy of Duloxetine with Placebo in Patients with Chronic Low Back Pai
- Conditions
- efficacy of duloxetine in the treatment of patients with chronic low back pain to placebo
- Registration Number
- EUCTR2009-012713-22-AT
- Lead Sponsor
- Medizinische Universität Wien, Univ. Klinik für Anästhesie, Allg. Intensivmedizin u Schmerztherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Age 18-65 years
•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
•Previous diagnostic imaging showing affliction of nerve roots
•Failed back surgery
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•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
•Participation in a clinical trial in the 3 weeks preceding the study
•Allergy of 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)
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method