Brain Imaging of Lidoderm for Chronic Back Pain

This study has been completed.
Sponsor:
Collaborator:
Endo Pharmaceuticals
Information provided by (Responsible Party):
Apkar Apkarian, Northwestern University
ClinicalTrials.gov Identifier:
NCT01515540
First received: January 18, 2012
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The investigators tested whether pain decrease can be observed centrally with non-invasive brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of 5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double blind, placebo controlled trial, where participants either received Lidoderm or placebo patches, without cross over.


Condition Intervention Phase
Low Back Pain
Drug: lidocaine
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Brain Imaging of Lidoderm for Chronic Back Pain

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents "no Pain" and 100 Was the "Worst Pain Imaginable". [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

    the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch.

    A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful.



Enrollment: 38
Study Start Date: January 2004
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: lidocaine
5% lidoderm patch
Drug: lidocaine
5% lidoderm patch
Other Names:
  • Lidoderm (Endo Pharmaceuticals)
  • 5% lidocaine patch
Placebo Comparator: control
placebo patch
Drug: placebo
placebo
Other Name: sham patch

Detailed Description:

Previous data showed that Lidoderm patches that contain 5% Lidocaine applied to the affected area for a period of 1-2 weeks decreased chronic pain. We conducted a preliminary open-label trial in chronic back pain patients and found that the patients reported reduction in pain intensity and associated brain activity (measured with fMRI). As a next step, we conducted a double blind clinical trial where the drug was tested against placebo to determine whether the effects on CBP were mediated by a pharmacological mechanism. For this we obtained psychophysical measurements of pain and measures of brain activity using fMRI. Two scans after treatment (6 hour and 2 weeks after treatment) were conducted to observe the effects of short term and long term use.

Brain activity was measured by the non-invasive method of functional imaging (fMRI), which enables examination of cortical blood flow during pain rating. These brain scans were acquired in chronic back pain patients while they rated their ongoing chronic pain using a finger span device. In a control task, each patient also rated the changes in the length of a bar n a screen (a visual control task). Anatomical scans were also acquired.

The general design of the study was that CBP subjects were assesses with fmri for brain responses for ongoing pain at three time points. The initial (baseline) scan occurred after a minimum of 48 hour period during which the patients refrained from taking analgesic medication. The patients were next scanned at 6 hours after treatment and again after 2 weeks of continuous treatment. Subjects were randomised to placebo or Lidoderm (both Lidoderm and placebo patches were supplied by Endo Pharmaceuticals).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or Female 18 years or older of age
  2. Pain in the location of the lower back
  3. Pain duration for a minimum of 6 months on a continuous basis
  4. Pain intensity of at least 3 out of 10 on most days of the week over the past six months
  5. Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks).
  6. Right handedness

Exclusion Criteria:

  1. Applying for or currently receiving workers' compensation or disability status.
  2. Back pain secondary to spinal cord injury
  3. Back pain secondary to any systemic condition (e.g ankylosing spondylitis0
  4. Diabetes mellitus
  5. Back pain secondary to tumors.
  6. Standard MRI criteria re: claustrophobia, metal objects etc.
  7. Subjects with cognitive deficits such as dementia, psychiatric illness including depression with a BDI score of more than 19 (moderate to severe depression), history of brain injury, history of chronic disease
  8. Pregnant and/or lactating women
  9. Left handedness
  10. Active cancer
  11. Other serious painful condition (e.g., arthritis)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515540

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Endo Pharmaceuticals
Investigators
Principal Investigator: Apkar V. Apkarian, PhD Northwestern University
  More Information

Publications:
Responsible Party: Apkar Apkarian, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01515540     History of Changes
Other Study ID Numbers: STU00022968
Study First Received: January 18, 2012
Results First Received: October 16, 2012
Last Updated: July 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
chronic back pain
placebo
fmri
brain imaging

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 22, 2014