efficacy of duloxetine in the treatment of patients with chronic low back pain to placebo
Conditions
Interventions
Trade Name: Cymbalta® 30 mg
Product Name: Cymbalta®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539-59-4
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Medizinische Universität Wien, Univ. Klinik für Anästhesie, Allg. Intensivmedizin u Schmerztherapie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Weekly mean of VAS-Score in the last week of each treatment period • Use of rescue medication ;Secondary Objective: • Beck Depression Inventory • Health related Quality of Life SF-36 (Siehe auch Wernicke) • Side effects/adverse events ;Primary end point(s): • Weekly mean of VAS-Score in the last week of each treatment period • Use of rescue medication | — |
Countries
Austria
Outcome results
None listed