Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
RecruitingNot applicableNCT05817786
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Moderate to severe neuropathic pain has a prevalence of 5% in the French population, involving the upper limb (UL) in 47%. Invasive neuromodulation, mainly spinal cord stimulation (SCS) is recommended as a third line treatment in refractory chronic neuropathic pain when optimized medical treatments are not sufficient to control pain. The implantation technique for BP roots PNS is based on the ultrasound-guided percutaneous inter-scalenic approach, routinely used for BP anesthetic blocks. As for SCS, BP PNS relies on chronic electrical stimulation of the nerve roots via chronically implanted devices (one lead connected to a subcutaneous generator). However efficacy of BP PNS has never been evaluated in controlled conditions. Our objectives are to assess, in controlled conditions, the effects of BP PNS in term of pain relief, quality of life improvement and safety.
Study details
- Official title
- Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots
- Conditions
- Interventions
- Device: electrical stimulation of the brachial plexus nerve roots
- Other: sham stimulation
- Sponsor
- Centre Hospitalier Universitaire de Nice
- Start date
- 2024-02-09
- Primary completion
- 2026-07-09
- Sex
- All
- Age range
- from 18 Months to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Eligibility will be determined by trained clinicians with expertise in chronic pain and neuropathic pain. * Patients between 18 and 80 years old * suffering from moderate to severe (VAS score \>5/10) chronic (duration\> 12 months) neuropathic (DN4 score ≥ 4/10) unilateral pain - located in the upper limb. * from peripheral origin, including complex regional pain syndrome type I and II, post-traumatic or post surgical pain. * refractory to first and second line treatments for neuropathic pain according recent French recommendations and guidelines\[6\], including serotonin- noradrenaline reuptake inhibitor (SNRI) antidepressants (duloxetine and venlafaxine), gabapentin, pregabalin, tricyclic antidepressants, topical lidocaine, high-concentration capsaicin patches, psychotherapy and combinations of them. Patient have signed informed consent \- Patient benefiting from French social insurance system Exclusion Criteria: * Brachial plexus avulsion * Post-zoster neuropathic pain * Phantom limb pain * Patient unable to fill a self-administered questionnaire * Patients with a chronic disease requiring repeated MRI monitoring * Patients with contra-indication to general anesthesia, surgery or percutaneous BP approach. * Patients with other pacemakers (cardiac pacemaker or defibrillator) or patients with a high risk to use a defibrillator due to a known cardiac disorder. * Patients with instable neuropsychological or psychiatric disorders * Vulnerable patients: pregnant or breast feeding, minor, adult under guardianship or deprived freedom
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05817786