Botulinum Toxin Type A for Treating Allodynic Pain in SCI and MS
Neuropathic Pain, Allodynia
About this trial
This is an interventional treatment trial for Neuropathic Pain
Eligibility Criteria
Inclusion Criteria:
- Fulfills the criteria for neuropathic pain causing allodynia according to IASP pain terminology.
- Allodynia that is resistant to, or has failed, the standard level of care measures for more that six months.
- Allodynia pain on a daily basis.
- Allodynia pain that scores at least 4/10 on a pain numerical scale.
- Other pain medications(including antidepressants and anticonvulsants)have been maintained at a stable dose for at least 2 months prior to enrollment.
- Ability to communicate in English.
Exclusion Criteria:
- Presence of other pain syndromes (e.g.,fibromyalgia, ongoing peripheral neuropathic pain.
- Allergy to Botulinum Toxin Type A.
- Allergy to albumin.
- Use of Botulinum Toxin Type A for other treatment indications in the 3 months prior to enrollment.
- Renal failure.
- Hepatic failure.
- Neuromuscular junction disorders.
- Bleeding diathesis.
- Cognitive impairment, dementia, major depression or psychotic disorder.
- Pregnant or breastfeeding.
- Infection at the injection site.
- Active alchohol or substance abuse.
Sites / Locations
- WRHA Health Sciences Centre Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Arm 1: Botulinum Toxin Type A
Arm 2: Normal Saline for Injection
200 units of Botulinum Toxin Type a will be administered intradermally to the allodynic area chosen for study.The allodynic area will be mapped, and the number of injections needed to cover the allodynic area without exceeding 40 injection sites will be determined. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any discomfort caused by the injections.
Normal saline for intradermal injection will be prepared by the Investigational Pharmacy in a manner as to be indistinguishable from active drug. The allodynic area will be mapped so as to determine the number of injections needed to cover the whole allodynic area without exceeding 40 injection sites. All participants will receive a cream formulation of lidocaine and prilocaine (EMLA) applied to the painful area 60 minutes before the injections to minimize any pain caused by the injections.