High Frequency Spinal Cord Stimulation for Neuropathic Pain Following Brachial Plexus Avulsion Injury: a Prospective Observational Cohort Study
概览
- 阶段
- 不适用
- 干预措施
- Adults with pain due to brachial plexus avulsion injury
- 疾病 / 适应症
- Brachial Plexus Injury
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in neuropathic pain
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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.
研究者
Christine (Christy) L. Hunt
Principal Investigator
Mayo Clinic
入排标准
入选标准
- •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.
排除标准
- •Pain that is non-neuropathic as defined by DN4 score \<
- •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).
研究组 & 干预措施
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.
结局指标
主要结局
Change in neuropathic pain
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
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.
Change in pain interference
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the PROMIS-CAT pain interference scale
Change in Douleur Neuropathique 4 (DN4) Questionnaire
时间窗: baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
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.
Change in multidimensional pain inventory
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the West Haven-Yale Multidimensional pain inventory self-reported questionnaire to assess the impact of pain on daily living
Change in pain intensity
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months, and 36 months
Measured using the PROMIS-CAT pain intensity scale
次要结局
- 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)
- Change in pain anxiety(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)
- Assessment of the effect of high frequency spinal cord stimulation in the above population on sensory function in the affected limb.(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)
- 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)