Efficacy of Transdermal Fentanyl for Chronic Neuropathic Pain

Johns Hopkins University53 enrolled

Overview

The efficacy of fentanyl TTS for the treatment of neuropathic pain remains to be established, although opioids in general are clearly effective for neuropathic pain and fentanyl TTS has been shown to be effective for treating other types of pain. We propose to measure functional outcomes, pain relief and side effects of fentanyl TTS for the treatment of neuropathic pain. Measures will be made at baseline and after titrating the drug to an effective level.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral Neuropathy Complex Regional Pain Syndromes (CRPS)

Interventions

Transdermal FentanylDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \>18 years * Neuropathic pain persisting for \> 3 months * Pain over the immediate previous three months * The average of the least and usual pain intensity rating of 3 or greater (0-10 numerical rating scale) during the last week prior to enrollment Exclusion Criteria: * A history of substance abuse * Allergic reaction to an opioid * Significant pain of alternate etiology other than the neuropathic pain state * Severe pulmonary disease * Recent myocardial infarction (within the preceding three months) * Pregnancy * Dementia * Encephalopathy * Those with life expectancy of less than six months and HIV seropositivity.

Outcomes

Primary Outcomes

Change in pain intensity (0-10) and daily activity

Secondary Outcomes

Pain relief (0-100%)

Cognition (digital symbol and grooved peg-board)

Impairment of function (MPI) and affect (BDI)

Data from ClinicalTrials.gov

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