Neurostimulation for Treatment of Chronic Upper Limb Pain After Brachial Plexus Injury
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Brachial Plexus Injury. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study
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.
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.
Primary outcome measures
- Change in neuropathic pain [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
- Change in multidimensional pain inventory [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 [Time frame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
- Change in pain intensity [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
- Change in pain interference [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
Secondary outcome measures (6)
- Change Disabilities of the Arm, Shoulder and Hand (DASH) disability/symptom score [Time frame: 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. [Time frame: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
- Change in mood [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
- Change in pain experience [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
- Change in pain anxiety [Time frame: 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. [Time frame: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Mayo Clinic — Jacksonville
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT04733599 · 20-000910