Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
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:
Duloxetine is a new substance now in use for the treatment of neuropathic pain. It has proven its efficacy in diabetic peripheral neuropathy and fibromyalgia in several trials. The investigators therefore hypothesize that duloxetine will be efficacious in patients with chronic low back pain and a radicular component.
Study Rationale:
Chronic low back pain is an extremely common diagnosis. However, therapeutic options for the condition are limited and therapy remains difficult. Duloxetine has proven its efficacy in patients with neuropathic pain and may also be useful in chronic low back pain. If the investigators are able to show a benefit for patients in the duloxetine arm, the substance may constitute a further treatment alternative in chronic low back pain.
Study Design:
Prospective, randomized, double-blind placebo-controlled cross over study. Patients will be administered duloxetine for 4 weeks followed by a 2 week wash-out phase after which they will be medicated with placebo for 4 weeks. A second group of patients will receive the medication in reversed order. The primary study endpoint is constituted the weekly mean of VAS-Score in the last week of each treatment period. Secondary endpoints are defined as use of rescue medication, Beck Depression Inventory score, Health related Quality of Life SF-36 score and side effects/adverse events.
Inclusion 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. 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:
if tapering of these drugs is impossible before inclusion.