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NCT Number: NCT01166048

Comparison of 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.

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Key information

Conditions

Chronic Low Back Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

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

    Time frame: Week 4 of study period

    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)

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

    Time frame: Week 10 of study period

Secondary outcomes

  1. Use of rescue medication in study phase I

    Time frame: Use of rescue medication in week 4 of study period

    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

  2. Beck Depression Inventory score in phase I of study period

    Time frame: Beck Depression Inventory score at week 4 of study period

    Subjects will be asked to perform the Beck Depression Inventory at screening and at week 4.

  3. 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.

    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)

  4. painDetect score in phase I of study period

    Time frame: painDetect score at week 4 of study period.

    Subjects will be asked to complete the painDetect questionnaire at screening and the end of each treatment period (placebo and verum).

  5. Use of rescue medication in phase II of study period

    Time frame: Use of rescue medication in week 10 of study period.

  6. Beck Depression Inventory score in phase II of study period

    Time frame: Beck Depression Inventory score at week 10 of study period.

  7. 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.

  8. painDetect score in phase II of study period

    Time frame: painDetect score at week 10 of study period.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Randomized Double-blind Study Comparing the Efficacy of Duloxetine With Placebo in Patients With Chronic Low Back Pain With a Radicular Component

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 20, 2010
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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