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

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

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.

Study Overview

• Status: Recruiting
• Conditions: 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 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 (Estimated): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Contact: Stephanie McNew, BS, CRC; Phone Number: 904-953-0580; Email: McNew.Stephanie@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Sharon Svoboda, RN; Phone Number: 507-255-8248; Email: svoboda.sharon@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	Measured using the EQ-5D.	baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in mood	Measured using the Center for Epidemiologic Depression Studies - Depression Scale. A 20-item self-reported questionnaire using a scale of 0 (rarely or none of the time) and 3 (most or all of the time) for a total score with high scores indicating the presence of more	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain experience	Change in self-reported 13-item Pain Catastrophizing scale of 0 (not at all) and 4 (all the time) for a total score with higher scores indicating higher levels of pain anxiety	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Change in pain anxiety	Measured using the self-reported Pain Anxiety Symptom Scale Short Form 20 to rate frequency of symptoms on a scale of 0 (never) to 5 (always) for a total score with higher score indicating high levels of pain-related anxiety	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.	Measured using Quantitative Sensory Testing	Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Christy Hunt, DO, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: January 27, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 20-000910