Using the Cholinergic Anit-Inflammatory Pathway to Treat Systemic Lupus Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Musculoskeletal pain.
研究概览
简要总结
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune, inflammatory disease and musculoskeletal pain is one of the most common symptoms. This study will investigate whether transcutaneous stimulation of the vagus nerve will decrease lupus musculoskeletal pain. This study will additionally investigate the biologic effects of vagus nerve stimulation on inflammation. It will be the first clinical study using one of the body's own pathways of modulating the immune system and inflammatory response, the cholinergic anti-inflammatory pathway, in SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years,
- •SLE (defined by the ACR or SLICC criteria),
- •Musculoskeletal pain ≥ 4 on a non-anchored VAS 10 cm scale
- •BILAG C on Musculoskeletal Domain of the BILAG 2004
- •If on corticosteroids, the dose must be stable and ≤ 10mg/day (prednisone or equivalent) for at least 28 days before baseline,
- •If on background immunosuppressive treatment the dose must be stable for at least 28 days before baseline
- •Able and willing to give written informed consent and comply with the requirements of the study protocol.
排除标准
- •Treatment with rituximab within one year of baseline (subjects with previous treatment with rituximab can enter study only with documentation of B cell repletion),
- •Treatment with cyclophosphamide within 2 months of baseline,
- •Expectation to increase steroids and/or immunosuppressive treatment,
- •Anti-phospholipid syndrome,
- •Fibromyalgia (fibromyalgia will be defined as a score > 13 on the Fibromyalgia Symptom Scale (FSS).
- •Treatment with an anti-cholinergic medication, including over the counter medications,
- •Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- •Current tobacco or nicotine user,
- •Joint replacement within 60 days prior to study enrollment or planned within the course of the study,
- •Any planned surgical procedure requiring general anesthesia within the course of the study,
- •Intra-articular cortisone injections within 28 days of the start of study,
- •Chronic inflammatory disorders apart from SLE affecting the joints,
- •Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
- •Active infection including hepatitis B or hepatitis C at baseline,
- •Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
- •Pregnancy or lactation,
- •Comorbid disease that may require administration of corticosteroid use,
- •Inability to comply with study and follow-up procedures.
研究组 & 干预措施
Vagus Nerve Stimulation
Subjects randomized to this arm will receive transcutaneous vagus nerve stimulation for 5 minutes on 4 consecutive days.
干预措施: Vagus nerve stimulation (Device)
Sham Vagus Nerve Stimulation
Subjects randomized to this arm will receive sham stimulation for 5 minutes for 4 consecutive days.
干预措施: Sham vagus nerve stimulation (Device)
结局指标
主要结局
Musculoskeletal pain.
时间窗: 5 days
Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
Percentage of Subjects With Treatment Emergent Adverse Events.
时间窗: 12 days
The percentage of participants with grade 2 or higher treatment emergent adverse events will be assessed using the NCI-CTAEversion4.
Change in Musculoskeletal Pain From Baseline.
时间窗: 5 days
Patients rate their musculoskeletal pain by making a mark on a 10cm anchored Visual Analog Scale where 0=no musculoskeletal pain and 10 =worst possible musculoskeletal pain.
次要结局
- SLE Disease activity(5 days)
- Tender and swollen joint counts(12 days)
- SLE cutaneous activity(12 days)
- Musculoskeletal Pain(12 days)
- Percentage of subjects with treatment emergent adverse events.(12 days)
- Fatigue(12 days)
- Fatigue(5 days)
- Change in Musculoskeletal Pain From Baseline(12 days)
- Tender Joint Reduction(5 days)
- Tender Joint Reduction(12 days)
- Swollen Joint Count Reduction(5 days)
- Swollen Joint Count Reduction(12 days)
- Physician Global Assessment of Disease Activity (PGA)(5 days)
- Physician Global Assessment of Disease Activity (PGA)(12 days)
- Patient Global Assessment of Disease (PtGA)(5 days)
- Patient Global Assessment of Disease (PtGA)(12 days)
研究者
Cynthia Aranow, MD
Investigator
Northwell Health