Subcutaneous Botulinum Toxin for Cutaneous Allodynia
|ClinicalTrials.gov Identifier: NCT00725322|
Recruitment Status : Completed
First Posted : July 30, 2008
Results First Posted : October 25, 2017
Last Update Posted : October 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Botulinum Toxin A Drug: Placebo - Saline||Not Applicable|
Post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimuli results in pain. Injected local anesthetics are often effective in providing temporary relief. In the course of clinical practice the investigators have observed that a number of patients with cutaneous allodynia have had marked persistent benefit from subcutaneous injection of Botulinum toxin Type A.
Rather than killing targeted neurons, Botulinum toxin type A inhibits release of acetylcholine from cholinergic nerve terminals in a prolonged but ultimately reversible manner. Neuropathic pain and its hallmark allodynia are classically difficult to treat. Standard treatment with tricyclic antidepressants, anti-epileptic drugs, opiates and spinal cord stimulation is frequently disappointing leaving patients with refractory pain. Surgical or percutaneous ablation of involved nerves has fallen out of favor among many due to disappointing results.
A pilot study is needed to assess the efficacy of superficially injected Botulinum Toxin type A for treatment of cutaneous allodynia and spontaneous pain among patients with neuropathic pain.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Subcutaneous Botulinum Toxin for Cutaneous Allodynia|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||March 2013|
|Experimental: Placebo then Botox||
Drug: Placebo - Saline
Subcutaneous Saline injection given at site of scar neuroma
|Experimental: Botox then Placebo||
Drug: Botulinum Toxin A
Subcutaneous injection of Botulinum Toxin Type A into the patient's scar tissue
- Time Until Analgesic Failure [ Time Frame: Each participant was assessed for up to 224 days per intervention (injection) or until they returned to NRS baseline ]Participants made daily NRS reports via Palm Pilot, and "failure" was defined as (Pre-injection baseline NRS) - (Mean NRS for any 3 preceding days) ≤ 0; or 9 months
- NRS Score Three Weeks After Injection [ Time Frame: Three weeks after injection ]The NRS scores range from 0-100, where 0 indicated no pain and 100 indicated the worst pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725322
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Ian R Carroll||Stanford University|
|Principal Investigator:||Sean Mackey||Stanford University|