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

Mayo Clinic20 enrolled

Overview

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.

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 stimulation (SCS). We plan to prospectively observe patients who undergo implantation of HF10 SCS for the indication of chronic neuropathic pain of the upper limb following brachial plexus avulsion injury.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Brachial Plexus Injury

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (2)

Mayo Clinic

Jacksonville, Florida, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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

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

Secondary Outcomes

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

Measured using the self-reported DASH 30-item questionnaire to assess the ability to perform activities. Total score on a scale of 0 indicating no disability to 100 indicating most serve disability

Data from ClinicalTrials.gov

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