A Pilot Prospective, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Pulsed Electromagnetic Field (PEMF) Therapy in Decreasing Post-Operative Pain Following Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days
研究概览
简要总结
The primary objective of this study is to prospectively determine, at 10 days after orthopedic shoulder or knee surgery, if pulsed electromagnetic field (PEMF) therapy is beneficial in reducing patient-reported post-operative pain, as measured by visual analog scale (VAS). The amount of pain medication taken daily and the physical function outcome scores after surgery and PEMF treatment will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Subjects may be male or female greater or equal to 18 years of age (≥ 18) at the time of consent.
- •Subjects who will be having shoulder or knee surgery are permitted.
- •Subject must not have used NSAIDs for one (1) week prior to surgery.
- •a. a. Low-dose aspirin (81 mg) is permitted.
- •Subject must be willing and able to participate in post-operative physical therapy exercises.
- •Subject must understand and be willing to sign the IRB-approved Informed Consent Document.
排除标准
- •Subject has a known collagen disorder such as, but not limited to, osteogenesis imperfecta (OI) or Ehlers-Danlos syndrome (EDS).
- •Subject has a known inflammatory or autoimmune connective tissue disease such as, but not limited to, gout affecting the shoulder, scleroderma, SLE, rheumatoid disease, or calcific tendonitis of the shoulder.
- •Subject has a metabolic bone disease such as Paget's disease or osteomalacia as documented in the medical record.
- •Subject has a deltoid defect, deltoid palsy or any other pseudoparalysis.
- •Subject is diabetic.
- •Subject has HIV or hepatitis.
- •Subject has a diagnosis of fibromyalgia or other chronic pain syndrome.
- •Subject has shoulder or knee pain of unknown etiology.
- •Subject has had an active malignancy in the past 5 years OR has an active or on-going neoplastic disease, except for benign skin cancer(s).
- •Subject has undergone administration, within 30 days prior to surgery, of any type of corticosteroid (with the exception of asthma medications and ophthalmic medications), antineoplastic, immunostimulation or immunosuppressive agent.
- •Subject is septic, or has a local or systemic infection.
- •Subject has an admitted active substance abuse problem which includes recreational drugs and/or narcotics or a history of substance abuse where history is defined as "not under the care of a physician" for more than 5 years.
- •a. Prescriptive medical marijuana is not permitted, including CBD oils.
- •Subject consumes more than 14 (men) or 7 (women) standard drinks (alcoholic units) per week where a drink equals a 12 oz. beer, or a 5 oz. glass of wine, or a 1.5 oz. shot of liquor.
- •Subject is currently seeking or receiving worker's compensation for this injury or for an injury that has occurred more than 12 months prior to enrollment in this study or subjects who are currently in litigation or who have a history of litigation related to musculoskeletal diagnoses.
- •Subject has major mental illnesses including major depression, bipolar disorder, schizophrenia or dementia that would prevent them from following the protocol and/or independently completing the patient reported outcomes measures.
- •Subjects who have coexistent cervical spinal pathologies such as radiculopathies or myelopathies.
- •Subject has a mental or physical condition that would prevent them from complying with the study protocol.
研究组 & 干预措施
Active PEMF Group
Participants will have a 1 in 2 chance to get the active treatment device post-operatively. The device will be attached to the post-operative dressing. The device is an Endonovo SofPulse that emits a pulsed electromagnetic field (PEMF). Single blind randomization.
干预措施: Endonovo SofPulse (Device)
Placebo PEMF Group
Participants will have a 1 in 2 chance to get the placebo treatment device post-operatively. The device will be attached to the post-operative dressing. The Endonovo SofPulse placebo device does not emit a pulsed electromagnetic field (PEMF). Single blind randomization.
干预措施: Endonovo SofPulse (Device)
结局指标
主要结局
Mean change from baseline in pain scores on the visual analog scale (VAS) at 10 days
时间窗: 10 days
The VAS is a subjective pain scale from 0 to 10, with 0 representing no pain.
次要结局
- Mean change from baseline in narcotic pain medicine use at 10 days(10 days)
研究者
Geoffrey Abrams
Assistant Professor of Orthopaedic Surgery
Stanford University