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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.

Primary Purpose

Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar sympathetic block with Botulinum Toxin type A
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:Severe pain in a lower extremity (greater than 6/10) of duration more than 6 months despite aggressive previous therapy including both previous lumbar sympathetic block, and previous trial of at least 4 different pain medications including at least 2 of the following: gabapentin, amitryptiline, desipramine, nortryptiline, imipramine, carbamazepine, valproic acid, mexiletine, oxcarbazepine, topiramate, lamotrigine, flecainide, zonisamide, venlafaxine and levetiracetam.

The severity of the pain must be such that the patient must perceive the function of the lower extremity to be compromised by the pain. Exclusion Criteria:Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy. Any ongoing legal action related to their pain. Any ongoing disability claim. A history of any severe psychiatric disorder. History of any adverse reaction to botulinum toxin. History of botulism. Untreated infection. Coagulopathy. Concurrent use of anticoagulant medications.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Botulinum Toxin Type A

Arm Description

Saline injection

Sympathetic Blockade containing Botulinum Toxin Type A

Outcomes

Primary Outcome Measures

Days of Analgesia

Secondary Outcome Measures

VAS Pain Score x Time

Full Information

First Posted
March 11, 2008
Last Updated
January 18, 2011
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00637533
Brief Title
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.
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

Brief 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.
Detailed Description
Lumbar sympathetic block will be performed twice on each patient: once as in the standard of practice with 10 cc 0.5% Bupivicaine and once with 75 units of Botox in 10cc of 0.5% Bupivicaine. These will be done in random order and the investigator and the patient will be blinded to which medicine they received. Two weeks after their pain has returned to 75% of their baseline they will receive the second of the blocks. Lumbar sympathetic blockade in the standard fashion is accomplished by placing an IV in the patient. The patient is then placed face down on a fluoroscopy table. They are then prepped and draped in a sterile fashion. Conscious sedation is provided with versed and Fentanyl in the operating room with monitoring of blood pressure, pulse oximetry, and ekg. The skin is topicalized with one cc of 1% Lidocaine. The L2 lumbar vertebral body is identified and under fluoroscopic guidance a 22 gauge 6 inch spinal needle is placed at the anterolateral border of the L2 vertebral body. The retroperitoneal space is identified with a loss of resistance technique. Correct needle positioned is confirmed radiographically and appropriate spread of medications is verified by injecting 3 cc of radio opaque contrast material. The needle will be aspirated to verify that it is not intravascular. Ten cc of Bupivicaine 0.5% will then be injected in divided dose to ensure safety. Between injections the patient will be asked to report ringing in the ears or tingling in the mouth. Subjects will be given a form asking them to rate their pain (from 0 to 10 where 0 is no pain and 10 is worst pain imaginable) at noon every day starting one week before the injection and continuing until they feel there pain has returned to baseline or two weeks whichever is longer. Days of analgesia will be the primary endpoint of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline injection
Arm Title
Botulinum Toxin Type A
Arm Type
Experimental
Arm Description
Sympathetic Blockade containing Botulinum Toxin Type A
Intervention Type
Procedure
Intervention Name(s)
Lumbar sympathetic block with Botulinum Toxin type A
Primary Outcome Measure Information:
Title
Days of Analgesia
Time Frame
Duration of Trial
Secondary Outcome Measure Information:
Title
VAS Pain Score x Time
Time Frame
Duration of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Severe pain in a lower extremity (greater than 6/10) of duration more than 6 months despite aggressive previous therapy including both previous lumbar sympathetic block, and previous trial of at least 4 different pain medications including at least 2 of the following: gabapentin, amitryptiline, desipramine, nortryptiline, imipramine, carbamazepine, valproic acid, mexiletine, oxcarbazepine, topiramate, lamotrigine, flecainide, zonisamide, venlafaxine and levetiracetam. The severity of the pain must be such that the patient must perceive the function of the lower extremity to be compromised by the pain. Exclusion Criteria:Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy. Any ongoing legal action related to their pain. Any ongoing disability claim. A history of any severe psychiatric disorder. History of any adverse reaction to botulinum toxin. History of botulism. Untreated infection. Coagulopathy. Concurrent use of anticoagulant medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian R Carroll
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19334078
Citation
Carroll I, Clark JD, Mackey S. Sympathetic block with botulinum toxin to treat complex regional pain syndrome. Ann Neurol. 2009 Mar;65(3):348-51. doi: 10.1002/ana.21601.
Results Reference
result

Learn more about this trial

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.

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