Neurostimulation for chronic upper limb pain after brachial plexus injury
High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study
This study is testing if spinal cord stimulation can help adults with chronic pain from a brachial plexus injury feel less pain over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT04733599 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the impact of high frequency spinal cord stimulation therapy on pain intensity in adults suffering from chronic neuropathic pain due to brachial plexus avulsion injury. Participants will be adults over 18 years old who are candidates for spinal cord stimulation. The study will observe these patients after the implantation of the stimulation device to assess changes in pain levels over time.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with neuropathic pain in the upper limb lasting at least three months following a brachial plexus avulsion injury.
Not a fit: Patients with non-neuropathic pain, active substance use disorders, or those who have not undergone conservative medical management may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic pain and improve the quality of life for patients with brachial plexus injuries.
How similar studies have performed: Other studies have shown promising results with spinal cord stimulation for neuropathic pain, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years old * Neuropathic pain of the upper limb ≥ 3 months following brachial plexus avulsion injury. * Patients must be planned to undergo implantation of high-frequency spinal cord stimulation for the treatment of chronic neuropathic pain due to brachial plexus avulsion injury. Exclusion Criteria: * Pain that is non-neuropathic as defined by DN4 score \<4. * Pregnant at the time of consideration for implant or planning to become pregnant during the study duration. * Active substance use disorder of any kind. * Active tobacco use. * Use of moderate or high dose opioid medication (oral morphine equivalents \>100 mg daily). * Active, untreated major psychiatric disorder that might interfere with subject's ability to participate. * Involvement in active litigation related to injury. * Patient has not undergone conservative medical management for at least 3 months (including physical and/or occupational therapy and at least one trial of neuropathic pain medication).
Where this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic — Jacksonville, Florida, United States (Recruiting)
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Christy Hunt, DO — Mayo Clinic
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.