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

Purpose

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.

Condition	Intervention	Phase
Chronic Low Back Pain	Drug: Duloxetine	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component

Resource links provided by NLM:

MedlinePlus related topics: Back Pain Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:

Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10) [ Time Frame: Week 4 of study period ] [ Designated as safety issue: No ]
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)
Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10) [ Time Frame: Week 10 of study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Use of rescue medication in study phase I [ Time Frame: Use of rescue medication in week 4 of study period ] [ Designated as safety issue: No ]
Patients will be allowed Metamizol (500mg up to 3g per day) and Tramadol drops (20 ggt. up to 6 times per day) as rescue medication. Rescue medication will be recorded daily in a patient diary. Use of rescue medication will be scored as follows: 0=no rescue medication; 1=metamizol; 2=tramadol
Beck Depression Inventory score in phase I of study period [ Time Frame: Beck Depression Inventory score at week 4 of study period ] [ Designated as safety issue: No ]
Subjects will be asked to perform the Beck Depression Inventory at screening and at week 4.
Health related Quality of Life SF-36 score in phase I of study period [ Time Frame: Health related Quality of Life SF-36 score at week 4 of study period. ] [ Designated as safety issue: No ]
Subjects will be asked to fill out the Health related Quality of Life SF-36 questionnaire at screening and at the end of each treatment period (placebo and verum)
painDetect score in phase I of study period [ Time Frame: painDetect score at week 4 of study period. ] [ Designated as safety issue: No ]
Subjects will be asked to complete the painDetect questionnaire at screening and the end of each treatment period (placebo and verum).
Use of rescue medication in phase II of study period [ Time Frame: Use of rescue medication in week 10 of study period. ] [ Designated as safety issue: No ]
Beck Depression Inventory score in phase II of study period [ Time Frame: Beck Depression Inventory score at week 10 of study period. ] [ Designated as safety issue: No ]
Health related Quality of Life SF-36 score in phase II of study period. [ Time Frame: Health related Quality of Life SF-36 score at week 10 of study period. ] [ Designated as safety issue: No ]
painDetect score in phase II of study period [ Time Frame: painDetect score at week 10 of study period. ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2010
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Milk powder pill Patients will receive 2 placebo pills per day for a period of 4 weeks.	Drug: Duloxetine 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 Drug: Duloxetine 2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
Experimental: Duloxetine 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 2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.

Arms

Assigned Interventions

Placebo Comparator: Milk powder pill

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

Drug: Duloxetine

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

Drug: Duloxetine

2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.

Experimental: Duloxetine

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

2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

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:
- 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)

if tapering of these drugs is impossible before inclusion.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166048

Contacts

Contact: Matthias Oehmke, MD	0043140400 ext 4137	matthias.oehmke@meduniwien.ac.at
Contact: Sibylle Pramhas, MD	0043140400 ext 4144	sibylle.pramhas@meduniwien.ac.at

Locations

Austria
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna	Recruiting
Vienna, Austria, 1090
Contact: Matthias Oehmke, MD 0043140400 ext 4137 matthias.oehmke@meduniwien.ac.at
Contact: Sibylle Pramhas, MD 0043140400 ext 4144 sibylle.pramhas@meduniwien.ac.at
Sub-Investigator: Sibylle Pramhas, MD
Sub-Investigator: Patricia Puehlhorn, MD

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator:

Matthias Oehmke, MD

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

More Information

No publications provided

Responsible Party:	Sibylle Pramhas, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT01166048 History of Changes
Other Study ID Numbers:	SPDP-01
Study First Received:	May 18, 2010
Last Updated:	December 1, 2012
Health Authority:	Austria: Agency for Health and Food Safety Austria: Ethikkommission

Keywords provided by Medical University of Vienna:

Chronic Low Back Pain
Radicular component
neuropathic pain
duloxetine
CLBP

Additional relevant MeSH terms:

Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013