RecruitingNot Applicable

Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury

United States20 participantsStarted 2021-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in neuropathic pain

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in multidimensional pain inventory

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in Douleur Neuropathique 4 (DN4) Questionnaire

Timeframe: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in pain intensity

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in pain interference

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Trial details

NCT IDNCT04733599

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Brachial Plexus Injury trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in neuropathic pain

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in multidimensional pain inventory

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in Douleur Neuropathique 4 (DN4) Questionnaire

Timeframe: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in pain intensity

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Change in pain interference

Timeframe: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months