Clinical trial NCT04733599: Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
Official title: High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brachial Plexus Injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in neuropathic pain
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in multidimensional pain inventory
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in Douleur Neuropathique 4 (DN4) Questionnaire
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in pain intensity
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in pain interference
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Secondary outcomes:
measure: Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: 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.
timeFrame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in mood
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in pain experience
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Change in pain anxiety
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
measure: Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Christy Hunt, DO
role: PRINCIPAL_INVESTIGATOR
References: