Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study
Perineural Incobotulinumtoxin-A for Complex Regional Pain Syndrome - An Open-label Feasibility Study (PINCom)
Bo Biering-Soerensen
20 participants
Jan 7, 2026
INTERVENTIONAL
Conditions
Summary
Complex Regional Pain Syndrome (CRPS) is a chronic pain condition characterized by severe regional pain, sensory disturbances, and functional impairment. Current treatment options are limited, and many patients experience substantial pain-related disability and symptom fluctuations, including flare-ups triggered by invasive procedures. Perineural administration of botulinum toxin A has shown analgesic effects in other neuropathic pain conditions and may represent a less painful alternative to subcutaneous injection techniques. However, the feasibility, tolerability, and safety of perineural botulinum toxin administration in patients with CRPS have not been systematically evaluated. The PINCom study is a single-center, open-label feasibility study designed to assess the safety, tolerability, and practical feasibility of ultrasound-guided perineural injection of incobotulinumtoxin-A in patients with unilateral chronic CRPS affecting an upper or lower limb. Participants receive a single perineural injection targeting major sensory nerves supplying the affected limb and are followed for 12 weeks. Primary outcomes focus on feasibility metrics, including recruitment, retention, adherence, and data completeness, as well as safety outcomes, including serious adverse events and procedure-related complications. Tolerability is assessed through monitoring of CRPS flare-ups and a dedicated qualitative interview exploring participant experience. Exploratory outcomes include pain intensity, CRPS severity, and patient-reported measures collected to inform the design of a future randomized controlled trial.
Eligibility
Inclusion Criteria7
- Are over the age of 18
- Have a diagnosis of CRPS type 1 or 2 in either one upper or one lower extremity which fulfils the Budapest research criteria
- Have had the condition for at least 6 months
- Rate CRPS as their primary pain condition
- Have been on a stable analgesic regimen, including any rescue medications, for at least 1 month prior to the study and intend to maintain this regimen throughout the study
- For pre-menopausal females: are using a safe and approved contraceptive
- Speak, read, and understand Danish
Exclusion Criteria11
- Are allergic to botulinum toxin A
- Have been treated with botulinum toxin A for any indication within 3 months prior to study start
- Are diagnosed with myasthenia, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, or any other condition which makes differentiation of CRPS-specific pain difficult
- Have an ongoing infection in the affected limb
- Do not intend to start physical therapy, psychotherapy, or any other non-pharmaceutical intervention aimed at reducing pain
- Have used a topical analgesic treatment such as lidocaine patches within 1 week prior to study start or have been treated with capsaicin patches in the affected area within 3 months prior to study start
- Have psychiatric comorbidities which are considered by the investigators to impact their ability to participate
- Consume alcohol in excess of what is recommended by the Danish Health Ministry
- Are active abusers of illicit narcotics
- Are pregnant, lactating, or plan on becoming pregnant during the study period
- Have any other condition or circumstance that, in the investigators' opinion, will hinder safe and timely participation and completion of the study
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Single perineural injection of 200 U iBonT-A around the brachial plexus in the case of upper limb CRPS, or 150 U iBonT-A around the distal ischial nerve and 50 U around the saphenus nerve in the case of lower limb CRPS.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07473635