RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study

Quick Facts

Study Start:2021-02-01

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04733599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Principal Investigator

Christy Hunt, DO

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic

Jacksonville, Florida, 32224

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Christy Hunt, DO, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-01

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-02-01

Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

Brachial Plexus Injury