Treatment of Upper Limb Chronic Neuropathic Pain by Electrical Stimulation of the Brachial Plexus Nerve Roots

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de Lyon
RECRUITING
Lyon
CHU de Nice
RECRUITING
Nice
CHU de Poitiers
RECRUITING
Poitiers
Contact Information
Primary
DENYS FONTAINE
fontaine.D@chu-nice.fr
0492034702
Time Frame
Start Date: 2024-02-09
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 48
Treatments
Experimental: BP PNS (experimental group)
Patients with refractory upper limb neuropathic pain treated by chronic electrical stimulation of the brachial plexus nerve roots
Active_comparator: sham stimulation (control group).
Patients with refractory upper limb neuropathic pain treated by sham stimulation
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Nice

This content was sourced from clinicaltrials.gov