Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component

NCT01166048 | Completed Phase 4 DMC

• 1 other identifier: SPDP-01
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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: 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.

Conditions

Chronic Low Back Pain

Keywords

Chronic Low Back Pain; Radicular component; neuropathic pain; duloxetine; CLBP

Outcome Measures

Primary Outcomes (2)

• Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)

  Operationally a VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end (left= no pain, right=worst imaginable pain).The patient marks the current subjective pain intensity on the scale. This is converted to a numeric value by measurement from the left side of the scale. (Units 1-10)

  Week 4 of study period

• Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10)

  Week 10 of study period

Secondary Outcomes (8)

• Use of rescue medication in study phase I

  Use of rescue medication in week 4 of study period

• Beck Depression Inventory score in phase I of study period

  Beck Depression Inventory score at week 4 of study period

• Health related Quality of Life SF-36 score in phase I of study period

  Health related Quality of Life SF-36 score at week 4 of study period.

• painDetect score in phase I of study period

  painDetect score at week 4 of study period.

• Use of rescue medication in phase II of study period

  Use of rescue medication in week 10 of study period.

Study Arms (2)

Milk powder pill

PLACEBO COMPARATOR

Patients will receive 2 placebo pills per day for a period of 4 weeks.

Drug: Duloxetine

Duloxetine

EXPERIMENTAL

In the experimental arm of the study patients will receive duloxetine, which will be titrated up to a dosage of 120mg over a period of two weeks and continued at this dosage for two weeks.

Drug: Duloxetine

Interventions

Duloxetine DRUG

Patients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo) day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg

Milk powder pill

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Neuralgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Matthias Oehmke, MD

  Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 18, 2010
• First Posted: July 20, 2010
• Study Start: May 1, 2010
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 31, 2014

Record last verified: 2014-07

Locations

AU (1)