Chronic Low Back Pain Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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