A Prospective, Comparative Effectiveness Randomized Controlled Trial of SPR Peripheral Nerve Stimulation (PNS) Therapy for the Treatment of Pain Following Total Knee Arthroplasty (TKA) Utilizing Preoperative Lead Placement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 10
- 主要终点
- Average Knee Pain While Walking
研究概览
简要总结
The purpose of this study is to determine if electrical stimulation (small levels of electricity) in addition to the standard of care can safely and effectively reduce pain following total knee replacement more than the standard of care, alone. This study involves a device called the SPRINT Beta System. The SPRINT Beta System delivers mild electrical stimulation to nerves in the leg that received the knee replacement. The SPRINT Beta System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator). About half the subjects in this study will receive the SPRINT Beta system (treatment group) and half will not (control group). Both groups will receive the standard of care.
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
- None
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo a primary unilateral total knee replacement procedure
排除标准
- •Body Mass Index > 40 kg/m2
- •Conditions that place the subject at increased risk of infection
- •History of valvular heart disease
- •Implanted electronic device
- •Bleeding disorder
- •Allergy to skin surface electrodes and/or medical-grade adhesive tapes
结局指标
主要结局
Average Knee Pain While Walking
时间窗: Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)
All subjects were asked to complete daily diaries to record their average pain intensity while walking during the past 24 hours on each day of a 7-day period using an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." For each subject, the mean score for each diary period was calculated and a mean of all four diary periods was calculated (weeks 1-4). The mean group scores for weeks 1-4 are reported.
Number of Subjects That Experienced at Least One Study-Related Adverse Event
时间窗: 30 months (from when the first Treatment Group subject enrolled to when the last Treatment Group subject completed the study)
At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition has occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of Treatment Group subjects that experienced at least one study-related adverse event is reported here.
次要结局
- Number of Physical Therapy Sessions Attended Following Total Knee Arthroplasty(Visit 5 (1-week post-Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 7 (3-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 9 (2-months post-TKA), and Visit 10 (3-months post-TKA))
- Average Knee Pain Over the Last 24 Hours(Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)))
- Pain Right Now as Measured by the Brief Pain Inventory(Baseline (Visit 2a/2b), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 4 (in-hospital), Visit 6 (2-weeks post TKA), and Visit 8 (4-weeks post TKA))
- Amount of Analgesic Usage(Visits 5-8 (weeks 1-4 post-Total Knee Arthroplasty (TKA)))
- Subject Satisfaction Survey(Visit 8 (4-weeks post-total knee arthroplasty (TKA)))
- Average Knee Pain at Rest(Postoperative Day 0 to 28 (first 4 weeks following Total Knee Arthroplasty (TKA)))
- Timed Up and Go (TUG) Test(Visit 1 (Baseline), Visit 4 (In-Hospital), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks Post-TKA))
- Pain Catastrophizing Scale (PCS)(Visit 1 (Baseline), Visit 8 (4 weeks post-Total Knee Arthroplasty (TKA)), Visit 10 (3-months Post-TKA))
- Number of Subjects That Experienced at Least One Opioid-Related Side Effect(Baseline (Visit 2a/2b), Visits 4-11 (in-hospital days through 12-months post-Total Knee Arthroplasty (TKA)))
- Six Minute Walk Test (6MWT)(Visit 1 (Baseline), Visit 6 (2-weeks Post-Total Knee Arthroplasty (TKA)), Visit 8 (4-weeks post-TKA))
- Number of Subjects Reporting Meaningful Improvement, Minimal or No Change, or Meaningful Worsening on the Patient Global Impression of Change (PGIC) Survey(Visits 3-11 (Day of Total Knee Arthroplasty (TKA) through 12-months post-TKA))
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Visit 1 (Baseline), Visit 3 (Day of Total Knee Arthroplasty (TKA)), Visit 6 (2-weeks post-TKA), Visit 8 (4-weeks post-TKA), Visit 10 (3-months post-TKA), and Visit 11 (12-months post-TKA))
- Time to Meet Recovery Milestones up to Twelve Months Post-Total Knee Arthroplasty (TKA)(From Day of Surgery through completion of milestone or 12-months from Day of Surgery, whichever came first)
- Inpatient Pain Management Experience Survey (Pain Management During Hospital Stay)(1-week post-Total Knee Arthroplasty (TKA))
- Inpatient Pain Management Experience Survey (Pain Medicine During Hospital Stay)(1-week post-Total Knee Arthroplasty (TKA))
- Inpatient Pain Management Experience Survey (Discharge Facility)(1-week post-Total Knee Arthroplasty (TKA))
- Subject's Use of Device (Compliance)(Visit 4 (In-Hospital), Visit 6 (2-weeks post-Total Knee Arthroplasty (TKA)), and Visit 8 (4-weeks Post-TKA))
- Inpatient Pain Management Experience Survey (Overall Rating of Hospital)(1-week post-Total Knee Arthroplasty (TKA)))