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

NCT04733599 | Recruiting

• 1 other identifier: 20-000910
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Brachial Plexus Injury

Outcome Measures

Primary Outcomes (5)

• Change in neuropathic pain

  Measured using the patient reported Neuropathic Pain Symptom Inventory (NPSI) which uses a scale of 0 = "have not felt such pain" and 10 = "feel it the worst" for a total score with a higher score indicates greater pain.

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

• Change in multidimensional pain inventory

  Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living

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

• Change in Douleur Neuropathique 4 (DN4) Questionnaire

  Change in DN4 questionnaire to estimate the probability of neuropathic pain with seven questions asking patients about quality of pain and three questions for physical examination of pain. Questions are yes = 1 or no = 0 to obtain a patient's total score out of 10, higher scores indicate more probability of pain.

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

• Change in pain intensity

  Measured using the PROMIS-CAT pain intensity scale

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

• Change in pain interference

  Measured using the PROMIS-CAT pain interference scale

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

Secondary Outcomes (6)

• Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score

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

• Assessment of the effectiveness of high frequency spinal cord stimulation in the above population in the improvement of quality of life as measured by validated patient-completed questionnaires.

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

• Change in mood

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

• Change in pain experience

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

• Change in pain anxiety

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

Study Arms (1)

Adults with pain due to brachial plexus avulsion injury

Adult patients with history of brachial plexus avulsion injury referred for consideration of neuromodulation using high frequency neurostimulation will be considered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with history of brachial plexus avulsion injury referred to the Pain Clinic for consideration of neuromodulation using high frequency neurostimulation will be considered.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Study Officials

• Christy Hunt, DO

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2021
• First Posted: February 2, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)