Status:
RECRUITING
Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
Lead Sponsor:
Mayo Clinic
Conditions:
Brachial Plexus Injury
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to see how much pain intensity is affected by high frequency spinal cord stimulation therapy in individuals with serious brachial plexus injury.
Detailed Description
This single-site prospective observational cohort study will include all adults (\> 18 years old) with brachial plexus avulsion injury who are candidates for high frequency (HF10) spinal cord stimulat...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
February 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04733599
Start Date
February 1 2021
End Date
December 1 2025
Last Update
May 26 2025
Active Locations (2)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224
2
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905