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

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Duloxetine
Duloxetine
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring Chronic Low Back Pain, Radicular component, neuropathic pain, duloxetine, CLBP

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Milk powder pill

Duloxetine

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Use of rescue medication in study phase I
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
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
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
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
Beck Depression Inventory score in phase II of study period
Health related Quality of Life SF-36 score in phase II of study period.
painDetect score in phase II of study period

Full Information

First Posted
May 18, 2010
Last Updated
July 29, 2014
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01166048
Brief Title
Comparison of the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Official Title
Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic Low Back Pain, Radicular component, neuropathic pain, duloxetine, CLBP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Milk powder pill
Arm Type
Placebo Comparator
Arm Description
Patients will receive 2 placebo pills per day for a period of 4 weeks.
Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Intervention Description
2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
Primary Outcome Measure Information:
Title
Weekly mean pain intensity in study phase I (Visual analogue score, units 1-10)
Description
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)
Time Frame
Week 4 of study period
Title
Weekly mean pain intensity in study phase II (Visual analogue score, units 1-10)
Time Frame
Week 10 of study period
Secondary Outcome Measure Information:
Title
Use of rescue medication in study phase I
Description
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
Time Frame
Use of rescue medication in week 4 of study period
Title
Beck Depression Inventory score in phase I of study period
Description
Subjects will be asked to perform the Beck Depression Inventory at screening and at week 4.
Time Frame
Beck Depression Inventory score at week 4 of study period
Title
Health related Quality of Life SF-36 score in phase I of study period
Description
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)
Time Frame
Health related Quality of Life SF-36 score at week 4 of study period.
Title
painDetect score in phase I of study period
Description
Subjects will be asked to complete the painDetect questionnaire at screening and the end of each treatment period (placebo and verum).
Time Frame
painDetect score at week 4 of study period.
Title
Use of rescue medication in phase II of study period
Time Frame
Use of rescue medication in week 10 of study period.
Title
Beck Depression Inventory score in phase II of study period
Time Frame
Beck Depression Inventory score at week 10 of study period.
Title
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.
Title
painDetect score in phase II of study period
Time Frame
painDetect score at week 10 of study period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Oehmke, MD
Organizational Affiliation
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna,
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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