Use of botulinum toxin to treat Complex Regional Pain Syndrome and its effects on skin nerves

Effect of Incobotulinumtoxin-A in Complex Regional Pain Syndrome: Analysis of Nerve Fiber Density in Skin Biopsies

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-9h7h2d5

Enrollment

Registered

2026-03-09

Start date

2025-08-01

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Interventions

This is a randomized controlled two-arm double-blind clinical trial conducted in patients diagnosed with Complex Regional Pain Syndrome according to the Budapest clinical criteria. The study includes

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients diagnosed with complex regional pain syndrome according to the Budapest criteria; age equal to or greater than 18 years; chronic pain refractory to conventional clinical treatment; ability to understand and sign the informed consent form

Exclusion criteria

Exclusion criteria: Pregnancy; active infection at the procedure site; uncorrected coagulopathies; severe psychiatric disorders that impair clinical evaluation; inability to understand the informed consent form

Design outcomes

Primary

Measure	Time frame
Evaluation of the variation in neuropathic symptoms using the Douleur Neuropathique en 4 Questions (DN4) scale; evaluation of the association between pain catastrophizing measured by the Pain Catastrophizing Scale (PCS) and clinical response to treatment; evaluation of the variation in painful area extension in square centimeters between D0, D30 and D90; evaluation of peripheral sudomotor function using the carbachol induced sudomotor test at D0 and D30	—

Measure

Time frame

Evaluation of the variation in neuropathic symptoms using the Douleur Neuropathique en 4 Questions (DN4) scale; evaluation of the association between pain catastrophizing measured by the Pain Catastrophizing Scale (PCS) and clinical response to treatment; evaluation of the variation in painful area extension in square centimeters between D0, D30 and D90; evaluation of peripheral sudomotor function using the carbachol induced sudomotor test at D0 and D30

—

Secondary

Measure	Time frame
No secondary outcomes are expected.	—

Countries

Contacts

Public ContactMarcelo dos Santos

Departamento de Medicina Clínica da Universidade Federal do Ceará

drmarceloaffonso@gmail.com+55-85-991154231

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Apr 4, 2026