Dorsal Root Ganglion Stimulation Outcomes for the Treatment of Mechanical Knee Pain Among Patients With Osteoarthritis of the Surgical and Non-surgical Knee
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Treatment success rate at 3 months
研究概览
简要总结
Dorsal root ganglion stimulation (DRG-S) may be able to treat mechanical pain caused by tissue injury or damage such as trauma or arthritis in addition to pain caused by nerve dysfunction or injury. The purpose of this study is to determine if dorsal root ganglion stimulation (DRG-S) can effectively treat arthritic pain of the knee.
详细描述
Dorsal root ganglion stimulation (DRG-S) is a novel form of neuromodulation used to treat chronic neuropathic pain of the groin and lower extremities related to complex regional pain syndrome type I or II (causalgia). DRG-S has shown promise in treating traditionally mixed neuropathic and mechanical pain syndromes such as axial low back pain, suggesting DRG-S may be able to treat mechanical pain in addition to neuropathic pain. Additionally, in a rodent model of osteoarthritis of the knee, DRG-S alleviated pain related behavior in rats.
This open label feasibility study seeks to evaluate if dorsal root ganglion stimulation with Abbott's Proclaim Dorsal Root Ganglion Neurostimulator System can effectively treat osteoarthritis of the knee. Patients with either osteoarthritis of the non-operated knee or osteoarthritis of the surgically repaired knee will be trialed for one week with dorsal root ganglion stimulation to determine if they positively respond with 50% or greater pain relief. For those patients that have a successful trial, they will be implanted with a permanent stimulation device system and followed for one year post implant to measure knee pain, function and disability, and other related outcomes with sustained DRG-S therapy.
Patients will be seen and evaluated prior to DRG-S trial, and for those that receive permanent implants, re-evaluated at 1, 3, 6, 9 and 12 months after implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >= 21 years old
- •Able to provide informed consent
- •Primary complaint of chronic knee pain for at least 1 year that interferes with functional activities
- •Current pain score on visual analog scale (VAS) intensity ≥60 mm
- •One of two groups: 1) Non-operated knee pain patients who want to pursue alternative therapies and delay surgery or are not candidates for knee arthroplasty based on age, frailty, non-operable condition, or poor outcome with other side arthroplasty, or 2) Post traumatic knee pain patients with history of surgical repair (such as meniscal or ligament repair).
- •Radiologic confirmation (x-ray/MRI/CT) of Kellgren-Lawrence OA grade of 2 (mild) or 3 (moderate) or 4 (severe) noted within 6 months for the index knee
- •Continued pain in the target knee despite at least 3 months of conservative treatments with documented failure of physical therapy and standard conservative therapy, including trials of at least two different classes of analgesic medication
- •Failure of one or more prior interventional pain procedures such intraarticular corticosteroid or hyaluronidase knee injections, cooled radiofrequency ablation therapy, or regenerative medicine or prior surgery of the knee
排除标准
- •Non-English speaking
- •Douleur neuropathique 4 (DN4) score ≥4
- •Receiving opioid analgesic medication at a dose of ≥90 mg oral morphine equivalents
- •Workers' compensation or no-fault insurance
- •Signs or symptoms of active infection in the index knee joint
- •Pregnancy
- •Presence of any contraindication for DRG stimulation, including neurological, medical, psychiatric, or social conditions.
- •Widespread pain conditions like fibromyalgia
- •Autoimmune/Inflammatory arthritic conditions such as Rheumatoid and psoriatic arthritis and other allied disorders (sjogren, felty, inflammatory bowl disease etc)
- •Collagen diseases (systemic lupus erythematosus, Scleroderma, etc)
- •Infectious arthritis
- •Evidence of prespecified joint safety conditions (eg, rapidly progressive OA, subchondral insufficiency fracture, osteonecrosis, pathologic fracture) in the index knee on screening radiographs
- •Scheduled for or anticipating any surgery during the trial period
结局指标
主要结局
Treatment success rate at 3 months
时间窗: 3 months post-implant
Percent of DRG-S implanted patients that successfully respond to stimulation therapy as defined by \>=50% reduction in reported pain score from baseline
次要结局
- VAS pain scores(1-, 3-, 6-, 9-, and 12 months post-implant)
- Western Ontario and McMaster Universities Arthritis Index (WOMAC) for knee pain patients(1-, 3-, 6-, 9-, and 12 months post-implant)
- European Quality of Life 5 Dimension (EQ-5D)(1-, 3-, 6-, 9-, and 12 months post-implant)
- Short Form 36 Mental Component Summary (SF-36 MCS)(1-, 3-, 6-, 9-, and 12 months post-implant)
- Pain Disability Index (PDI)(1-, 3-, 6-, 9-, and 12 months post-implant)
- Patient Global Impression of Change (PGIC)(1-, 3-, 6-, 9-, and 12 months post-implant)
- Medication Dosage(1-, 3-, 6-, 9-, and 12 months post-implant)
- Timed Up and Go (TUG)(1-, 3-, 6-, 9-, and 12 months post-implant)
- Knee Range of Motion (ROM)(1-, 3-, 6-, 9-, and 12 months post-implant)
- Serum concentrations of molecular biomarkers(3-, 6-, and 12-months post-implant)
- Kellgren-Lawrence System for Classification of Osteoarthritis(6- and 12-months post-implant)
- Treatment success rate at other post-implant timepoints(1-, 6-, 9-, and 12-months post-implant)
研究者
Kenneth B Chapman
Principle Investigator
Spine and Pain Institute of New York