NCT01515540

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4 low-back-pain

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_4 low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

July 30, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

6.4 years

First QC Date

January 18, 2012

Results QC Date

October 16, 2012

Last Update Submit

July 23, 2013

Conditions

Low Back Pain

Keywords

chronic back painplacebofmribrain imaging

Outcome Measures

Primary Outcomes (1)

  • 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".

    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.

    2 weeks

Study Arms (2)

lidocaine

ACTIVE COMPARATOR

5% lidoderm patch

Drug: lidocaine

control

PLACEBO COMPARATOR

placebo patch

Drug: placebo

Interventions

lidocaineDRUG

5% lidoderm patch

Also known as: Lidoderm (Endo Pharmaceuticals), 5% lidocaine patch
lidocaine
placeboDRUG

placebo

Also known as: sham patch
control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Applying for or currently receiving workers' compensation or disability status.
  • Back pain secondary to spinal cord injury
  • Back pain secondary to any systemic condition (e.g ankylosing spondylitis0
  • Diabetes mellitus
  • Back pain secondary to tumors.
  • Standard MRI criteria re: claustrophobia, metal objects etc.
  • 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
  • Pregnant and/or lactating women
  • Left handedness
  • Active cancer
  • Other serious painful condition (e.g., arthritis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Baliki MN, Geha PY, Jabakhanji R, Harden N, Schnitzer TJ, Apkarian AV. A preliminary fMRI study of analgesic treatment in chronic back pain and knee osteoarthritis. Mol Pain. 2008 Oct 25;4:47. doi: 10.1186/1744-8069-4-47.

    PMID: 18950528RESULT

MeSH Terms

Conditions

Low Back Pain

Interventions

LidocaineLidoderm

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Javeria Ali Hashmi
Organization
Northwestern University
j-hashmi@northwestern.edu
3125037991

Study Officials

  • Apkar V. Apkarian, PhD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

January 1, 2004

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

July 30, 2013

Results First Posted

July 30, 2013

Record last verified: 2013-07

Locations

US(1)