Patient Observational Pain and Activity Survey (POPAS) Study Using RS-4i Sequential Stimulator With Intersperse Technology in Axial Spine and Peripheral Joint Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Level of Pain / Function using NRS
研究概览
简要总结
Spine pain and joint pain are among the most common worldwide ailments and directly contributes to disability as well as increased duration of care. Spine and joint pain affect work sick leave, production and increased financial costs to healthcare. Non-invasive treatments for spine and joint pain can vary widely from lifestyle changes, physical therapy, oral medication, and select medical devices, that can improve pain level and help improve the quality of life of individuals. Thus, the general population suffers from an ailment that has multiple conservative treatment options with variable outcomes.
Transcutaneous Electrical Neuromuscular Stimulation (TENS) has been show to decrease pain and restore function. Interferential therapy (INF) is a specific signal type that is effective for reducing musculoskeletal pain. Neuromuscular Electrical Stimulation (NMES) uses a specific signal type to cause muscles to contract and therefore provide functional improvement. The RS-4i Plus is an FDA-regulated prescription TENS medical device that outputs an INF signal and a NMES signal, and a unique Intersperse signal, which combines NMES and INF into a single treatment. Therefore, the goal of this study is to determine if use of the prescribed RS-4i Plus in patients presenting with pain, axial or peripheral joint, can be efficacious in decreasing the patient's pain and improving their activity measured at one month, three months, and six months of use.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •chronic and persistent MSK lumbar back pain for greater than 12 weeks as documented in patient records
- •Age 18 to 89
- •Willingness to comply with study protocol
- •Signed Patient Consent on file
- •Verified patient usage collected from RS-4i Plus via patient data adapter
排除标准
- •Any contraindications, as indicated in the RS-4i Plus prescribing information
- •Substantial allergy to adhesives
- •Skin infection or irritation of skin where electrodes are to be placed
- •Pacemaker/ICD
- •Abnormal skin sensation
- •Serious psychological disorder
- •End-stage cardiac, peripheral arterial or pulmonary disease
- •h/o recent vertebral fracture
- •Severe degenerative or traumatic neuromuscular disease
- •Non-English speaking
- •Uncontrolled diabetes meelitus (Hb A1c> 8.5%)
- •ESRD or ESHD
- •Active cancer
结局指标
主要结局
Level of Pain / Function using NRS
时间窗: 6 months
Outcome with be rated on a scale of 0-10, in which 10 is the most severe pain / worst function and 0 is the least pain / best function. The time frame will include assessment at 6 month interval to determine if the intervention is showing a change or long term improvement in the pain / function
次要结局
未报告次要终点
研究者
David Majors
Principal Investigator
University of California, Irvine
