Botulinum Toxin Type A for Cold Intolerance Secondary to Digital Amputations and Replantations: A Pilot Study
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
28 participants in 2 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal