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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Sibylle Pramhas, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01166048
First received: May 18, 2010
Last updated: April 7, 2014
Last verified: April 2014

May 18, 2010
April 7, 2014
May 2010
May 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01166048 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison of 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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Low Back Pain
  • 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.
  • Placebo Comparator: Milk powder pill
    Patients will receive 2 placebo pills per day for a period of 4 weeks.
    Interventions:
    • Drug: Duloxetine
    • Drug: Duloxetine
  • 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.
    Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
May 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Matthias Oehmke, MD 0043140400 ext 4137 matthias.oehmke@meduniwien.ac.at
Contact: Sibylle Pramhas, MD 0043140400 ext 4144 sibylle.pramhas@meduniwien.ac.at
Austria
 
NCT01166048
SPDP-01
Yes
Sibylle Pramhas, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Matthias Oehmke, MD Department of Special Anesthesia and Pain Therapy, Medical University of Vienna, AKH Vienna,
Medical University of Vienna
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP