botulinum toxin type a for cold intolerance secondary to digital amputations and replantations: a pilot study

Conditions: Cold Intolerance

Summary: patients will be selected for cold intolerance after finger amputation or replantation. they will be given botox or placebo dose as treatment and assessed over 3 months.

aim 1: to assess the efficacy of botulinum toxin type a on treating cold intolerance secondary to digital amputations, revascularizations, or replantations primary null hypothesis: randomized subjects who receive botulinum toxin type a injections for pain associated with cold intolerance will experience similar changes in pain as compared to patients randomized to receive saline injections (control) • as measured by the cold insensitivity and severity score (ciss) at one week, four weeks, and twelve weeks aim 2: to assess the safety of botulinum toxin type a on treating cold intolerance secondary to digital amputations and replantations hypothesis: injection of botulinum toxin for cold intolerance secondary to digital amputations and replantations is not associated with any adverse reactions iii. subject selection all adult, english-speaking patients who present with cold intolerance secondary to digital amputation or replantation will be approached and asked to participate in the study. inclusion criteria adults (≥18 years) diagnosed with cold intolerance secondary to digital amputations, revascularizations, or replantations and a ciss score of 30 or higher (the threshold for pathological cold intolerance)11 ability to give informed consent exclusion criteria adults ≥ 75 years old inability or unwillingness to participate in ciss or dash survey major medical comorbidity expected to worsen in the next 6 months comorbid chronic pain condition severe and untreated mental health conditions or active substance dependence pregnant or breastfeeding known hypersensitivity to botulinum toxin patients with a compromised respiratory function pre-existing neuromuscular disorders receiving therapy with aminoglycosides, anticholinergic agents, and muscle relaxants infection in the proposed injection site all patients who satisfy the inclusion/exclusion criteria will be eligible for enrollment. vulnerable populations will be excluded from this study. iv. subject enrollment a total of twenty-eight patients will be enrolled.

Eligibility criteria:
inclusion criteria: * adults (≥18 years) diagnosed with cold intolerance secondary to digital amputations, revascularizations, or replantations and a ciss score of 30 or higher (the threshold for pathological cold intolerance)11 ability to give informed consent exclusion criteria: * adults ≥ 75 years old inability or unwillingness to participate in ciss or dash survey major medical comorbidity expected to worsen in the next 6 months comorbid chronic pain condition severe and untreated mental health conditions or active substance dependence pregnant or breastfeeding known hypersensitivity to botulinum toxin patients with a compromised respiratory function pre-existing neuromuscular disorders receiving therapy with aminoglycosides, anticholinergic agents, and muscle relaxants infection in the proposed injection site