Proposal to Evaluate the Efficacy of the InterX 5000 in the Treatment of Chronic Neck and Shoulder Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
The purpose of the proposed study is to evaluate the efficacy of the InterX 5000 in relieving chronic neck and shoulder pain. This study will focus on the efficacy of treating patients who have functional limitations in activity because of chronic/recurrent neck or shoulder pain.
H1: InterX therapy will have a moderate effect to reduce pain.
H2: Functional gains will be greater in patients receiving InterX therapy compared to those who received placebo treatment.
H3: Chronic neck and shoulder pain is more prevalent in patients who exhibit radiographic evidence of degenerative spondylosis/arthrosis of the cervical spine.
详细描述
Electrical stimulation modalities of various types have been used as a therapeutic intervention for years in a wide variety of applications. Individuals with neck and shoulder pain represent a significant segment of the pain population seeking relief. However, there is a paucity of data from quality studies published in mainstream peer-reviewed journals supporting the effectiveness of this intervention. No well-designed prospective, randomized, controlled trials investigating the efficacy or effectiveness of this intervention in patients with chronic neck and shoulder pain have been reported. The need for such work is becoming increasingly important considering the progressively greater demands for evidence-based medicine to justify reimbursement for care.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 66 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic or recurrent neck or shoulder pain of at least 3 months duration with or without arm pain
- •willing to sign consent for study participation
- •able/willing to comply with treatment schedule
排除标准
- •clinically significant herniated disc (defined as positive radicular arm pain aggravated by head position change or neural stretch signs from provocative arm movement, this will not exclude patients with any imaged herniation as this is a common finding in all populations)
- •spinal fracture
- •previous electrical stimulation treatment for this episode
- •recent cervical spinal or shoulder surgery or implanted instrumentation/prostheses.
- •patients with cardiac pacemaker or spinal cord stimulator, epilepsy, pregnancy, recent (3 months) chemotherapy/radiotherapy, phlebitis, cortisone use (30 days)
研究组 & 干预措施
1
InterX treatment plus rehabilitation exercises
干预措施: InterX 5000 Treatment (Device)
2
Inactive InterX treatment plus rehabilitation exercises
干预措施: Inactive InterX 5000 (Device)
结局指标
主要结局
Visual Analog Scale
时间窗: 4 weeks
Neck Disability Index (NDI)
时间窗: 4 weeks
Medical Outcomes Study Short-Form 36 (SF-36) Health Survey
时间窗: 4 weeks
Short-Form McGill Questionnaire
时间窗: 4 weeks
Biomarkers (inflammatory cytokines and SP)
时间窗: 4 weeks
Functional Impairment Test-Hand, and Neck, Shoulder, Arm (FIT-HaNSA)
时间窗: 4 weeks
Cervical Range of Motion (CROM)
时间窗: 4 weeks
Grip strength
时间窗: 4 weeks
Vibration threshold
时间窗: 4 weeks
Pain Tolerance and Threshold - Pressure
时间窗: 4 weeks
Pain Threshold and Tolerance - Current Perception
时间窗: 4 weeks
Current Perception Threshold
时间窗: 4 weeks
Neck Walk Index (NWI)
时间窗: 4 weeks
Muscle Fatigue
时间窗: 4 weeks
次要结局
未报告次要终点