Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study

The PINCom study is a single-center, open-label feasibility study designed to evaluate the practical feasibility, safety, and tolerability of ultrasound-guided perineural injection of incobotulinumtoxin-A in adults with unilateral CRPS of an upper or lower limb. Depending on the anatomical distribution of symptoms, injections are administered at the supraclavicular brachial plexus (upper limb) or at distal sciatic and/or femoral nerve targets (lower limb). All procedures are performed under ultrasound guidance in a single treatment session. The primary objective of the study is to determine whether a larger randomized controlled trial of perineural incobotulinumtoxin-A in CRPS is feasible at the study center. Feasibility outcomes include recruitment rate, screening-to-enrollment ratio, retention, adherence to study visits and daily pain diary completion, and completeness of outcome data. Safety is assessed through monitoring of serious adverse events and targeted screening for procedure-related complications, potential nerve injury, and signs of systemic botulinum toxin spread. Adverse events are recorded throughout the study period. Given the clinical characteristics of CRPS, flare-ups are monitored separately as a tolerability outcome rather than as a primary safety endpoint. Tolerability and participant experience are evaluated using a combination of structured symptom monitoring and a semi-structured qualitative interview conducted during follow-up. The interview explores participants' experiences of the injection procedure, perceived burden of study participation, and acceptability of the intervention. This qualitative component is intended to inform protocol refinement and patient-centered trial design. Exploratory clinical outcomes are collected to characterize symptom variability and inform future trial design. These include daily pain intensity ratings, CRPS Severity Score assessments, sensory symptom mapping, and patient-reported outcome measures assessing pain quality, psychological factors, physical function, and quality of life. These measures are not powered to assess efficacy but will be used to estimate variability and optimal outcome timing for a future definitive trial. Participants are followed for 12 weeks after treatment. Findings from this feasibility study will be used to guide decisions regarding the design, outcome selection, and operational aspects of a subsequent randomized controlled trial evaluating perineural incobotulinumtoxin-A for the treatment of CRPS.