Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial
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Purpose
Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. the investigators propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).
| Condition | Intervention |
|---|---|
|
Pain |
Drug: Botulinum Toxin Type A Drug: Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial |
- Time to analgesic failure [ Time Frame: Duration of trial ] [ Designated as safety issue: No ]
- Reduction in area of allodynia and hyperalgesia [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Improvement in psychosocial function as assessed by outcomes as dictated by the IMMPACT Guidelines [ Time Frame: Duration of Trial ] [ Designated as safety issue: No ]
- Proportion of patients experiencing a reduction of 2 points or more on NRS, three weeks after injection, compared to baseline NRS [ Time Frame: 3 weeks after injection ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Drug: Saline
Subcutaneous injection of saline into scar tissue
|
| Experimental: Botulinum Toxin Type A |
Drug: Botulinum Toxin Type A
Patients receive a subcutaneous injection of Botulinum Toxin Type A into the scar tissue
|
Detailed Description:
Patients with post-herpetic neuralgia, complex regional pain syndrome, and 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy, excluding botox injection
- The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
- Patient reports more than 3 weeks of greater than 50% pain relief from previous botox injection
- The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar in the absence of the botox injection
- Age 18-100
- Ability to read, write, and converse in English, provide informed consent, and follow study procedures
Exclusion Criteria:
- Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
- Any ongoing legal action related to their pain
- Allergy to local anesthetics
- Any ongoing disability claim
- Currently being treated for any severe psychiatric disorder, including anxiety or depression
- History of any adverse reaction to botulinum toxin
- History of botulism
- Untreated infection
- Coagulopathy
- (Females) - positive pregnancy test
- Surgery in the last 6 months
Contacts and Locations| 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 |
More Information
No publications provided
| Responsible Party: | Sean Mackey, Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00822926 History of Changes |
| Other Study ID Numbers: | SU-01072009-1499, 15601 |
| Study First Received: | January 14, 2009 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013