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Treatment of posttraumatic neuralgia - Changes in central pain processing and somatosensory profile after injection of Botulinumtoxin-A compared to placebo

Treatment of posttraumatic neuralgia - Changes in central pain processing and somatosensory profile after injection of Botulinumtoxin-A compared to placebo

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
DRKS
Registry ID
DRKS00013548
Enrollment
45
Registered
2017-12-06
Start date
2018-10-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

posttraumatic neuropathic pain after peripheral nerve leasion

Interventions

Group 1: 100 Units Botulinumtoxin-A per nerve und 2 ml Ropivacain 0,5% as perineural injection Group 2: 1 ml Ropivacain 0,5% and 1 ml NaCl 0,9% (placebo) per nerve as perineural injection

Sponsors

Abteilung für SchmerzmedizinBerufsgenossenschaftliches Universitätklinikum Bergmannsheil gGmbH Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diagnosis of painful neuralgia after peripheral nerve injury, average pain > 4 on numeric rating scale (0-10) in the last two weeks, evidence for nerve leasion (current/anamnestic)

Exclusion criteria

Exclusion criteria: Age > 18 years, pregnancy, contraindications against injection or FMRI, other neurological or psychiatric diseases, CRPS (Complex regional pain syndrome)

Design outcomes

Primary

MeasureTime frame
Rate of patients with relevant pain reduction (50%) within one week after injection of Botulinumtoxin-A in comparison to placebo with pain diaries, pain questionnaires, quantitative sensory testing, fMRI, conditioned pain modulation

Secondary

MeasureTime frame
Extent of the avergae pain reduction, changes in peripheral sensory system, central pain modulation with pain diaries, pain questionnaires, quantitative sensory testing, fMRI, conditioned pain modulation

Countries

Germany

Contacts

Public ContactNina Kumowski

Abteilung für SchmerzmedizinBerufsgenossenschaftliches Universitätklinikum Bergmannsheil gGmbH Bochum

nina.kumowski@bergmannsheil.de0234 302-3248

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026