Perineural incobotulinumtoxin-A for unilateral CRPS of an arm or leg

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PINCom study is a single-center, open-label feasibility study testing a single ultrasound-guided perineural injection of 200 U incobotulinumtoxin-A in adults with unilateral chronic CRPS of an upper or lower limb. Injection sites are chosen based on symptom distribution and include the supraclavicular brachial plexus for upper-limb CRPS or distal sciatic and/or femoral nerve targets for lower-limb CRPS, all performed under ultrasound guidance in one treatment session. Primary outcomes focus on feasibility measures such as recruitment rate, retention, adherence to visits and daily pain diaries, and completeness of outcome data, while safety is monitored via adverse event reporting and targeted screening for procedure-related complications and systemic toxin spread. Tolerability and participant experience are assessed with structured symptom monitoring and a semi-structured qualitative interview during follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• CRPS- and Nerve Pain Clinic, Rigshospitalet Glostrup
  Glostrup, Region Sjælland, Denmark Recruiting

Study contacts

• Study coordinator: Marc K Olsen, MD
• Email: marc.klee.olsen@regionh.dk
• Phone: +45 38633030

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Conservative treatment combining rTMS and functional neurological rehabilitation for CRPS

  This project will try whether adding repetitive transcranial magnetic stimulation (rTMS) and functional neurological rehabilitation to standard physical therapy and medication helps adults aged 18–70 with CRPS of less than five years reduce pain and regain function.

  Recruiting Oulu University Hospital · Oulu, North Ostrobothnia · NCT07208825

• Intermittent Dorsal Root Ganglion Stimulation for Chronic Pain Relief

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• Non-invasive brain stimulation to see if it changes pain avoidance in CRPS

  This study tests whether a gentle brain stimulation method called tACS can change how people with complex regional pain syndrome avoid activities that might worsen their pain.

  Recruiting The Cleveland Clinic · Cleveland, Ohio · NCT07791966

• tDCS for CRPS: see if a non‑invasive brain stimulation helps reduce pain

  This trial tests whether transcranial direct current stimulation can lessen pain and improve mood and function for people with complex regional pain syndrome.

  Recruiting Polyclinique de l'Europe · Saint-Nazaire · NCT07361692

• Peripersonal space changes with upper limb segmental exclusion

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  Recruiting Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est · Nancy · NCT07349173

• CRPS rehabilitation with graded imagery and desensitization tailored to you

  This study tests a personalized rehab program for CRPS to see if it improves daily functioning and pain, with MRI to explore brain changes.

  Recruiting University Hospital of North Norway · Tromsø · NCT02753335

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.