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A Pilot Clinical Trial of Sympathetic Blockade With Botulinum Toxin Type A to Treat Complex Regional Pain Syndrome (CRPS): a Randomized, Double-Blind, Controlled, Crossover Trial.

NCT00637533 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-01-19

No results posted yet for this study

Summary

Lumbar sympathetic blocks are part of the standard of care for treating patients with sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic dystrophy- RSD). In these patients lower extremity pain can be reduced or abolished temporarily by blocking sympathetic nerves by doing a lumbar sympathetic block. Patients who respond only transiently to sympathetic blocks often choose between potentially dangerous lumbar sympathetic block with neurolytic agents, surgical sympathectomy, continued severe refractory debilitating pain or other risky invasive surgical procedures such as spinal cord electrical stimulation.. It is hypothesized that Botulinum Toxin Type A (BTA) injected in a lumbar sympathetic block can provide extended sympathetic blockade and thus pain relief. This pilot study aims to see if BTA can be used safely in lower extremity sympathetic blocks, and might be useful in providing prolonged pain relief.

Conditions

Interventions

PROCEDURE

Lumbar sympathetic block with Botulinum Toxin type A

Sponsors & Collaborators

Principal Investigators

  • Ian R Carroll · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-31
Primary Completion
2007-05-31
Completion
2007-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00637533 on ClinicalTrials.gov