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

ConditionNeuralgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Brachial plexus avulsion

Post-zoster neuropathic pain

Phantom limb pain

Patient unable to fill a self-administered questionnaire

Trial design

Treatments tested in this trial

  • electrical stimulation of the brachial plexus nerve roots
  • sham stimulation

Treatment groups

48 Participants
are divided into 2 treatment groups