Subcutaneous Botulinum Toxin for Cutaneous Allodynia
| Status: | Completed |
|---|---|
| Conditions: | Chronic Pain, Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2017 |
| Start Date: | December 2007 |
| End Date: | March 2013 |
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).
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).
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.
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.
Inclusion Criteria:- Moderate to severe pain (greater than 4/10) of duration more than 6
months despite previous therapy.
- The patient exhibits at least 80% pain relief following injection of local anesthetic
subcutaneously into scar as assessed by change in NRS
- The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or
hypoesthesia surrounding the scar
- Age 18-100
- Ability to read, write, and converse in English, provide informed consent, and follow
study procedures
Exclusion Criteria:
1. Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular
dystrophy
2. Any ongoing legal action related to their pain
3. Allergy to local anesthetics
4. A current or history of any severe psychiatric disorder
5. History of any adverse reaction to botulinum toxin
6. History of botulism
7. Untreated infection
8. Coagulopathy
9. Females - positive pregnancy test
10. Surgery within the past 6 months at the site of the painful scar
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