Electrical stimulation for chronic upper limb pain relief

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

This study is testing if electrical stimulation of certain nerves can help people with chronic pain in their arms feel better when other treatments haven’t worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Months to 80 Years
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nice (Academic / other)
• Locations: 3 sites (Lyon, France and 2 other locations)
• Trial ID: NCT05817786 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of electrical stimulation of the brachial plexus nerve roots in alleviating moderate to severe chronic neuropathic pain in the upper limb. The study employs a controlled approach to assess pain relief, quality of life improvements, and safety outcomes in patients who have not responded to conventional treatments. Participants will receive either active stimulation or sham stimulation, with the implantation technique guided by ultrasound for precision. The trial aims to provide robust evidence on the efficacy of this novel neuromodulation technique.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with moderate to severe unilateral chronic neuropathic pain in the upper limb that has persisted for over 12 months and is refractory to first and second line treatments.

Not a fit: Patients with brachial plexus avulsion or post-zoster neuropathy may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce chronic pain and improve the quality of life for patients suffering from neuropathic pain in the upper limb.

How similar studies have performed: While peripheral nerve stimulation has shown promising results in small series, this specific approach for brachial plexus stimulation has not been extensively evaluated in controlled conditions.

Eligibility criteria

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

Where this trial is running

Lyon, France and 2 other locations

• CHU de Lyon — Lyon, France, France (Recruiting)
• CHU de Nice — Nice, France, France (Recruiting)
• CHU de Poitiers — Poitiers, France, France (Recruiting)

Study contacts

• Principal investigator: Denys FONTAINE — Centre Hospitalier Universitaire de Nice
• Study coordinator: Denys Fontaine

Conditions Neuralgia