The Effects of SlumberCurve™ Following Rotator Cuff Surgery: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Fitbit Sleep Data - Time spent awake, restless, and asleep
研究概览
简要总结
The purpose of this study is to investigate the effects of a novel sleep aid known as SlumberCurve™, which serves as an adjustable form of a wedge pillow, on sleep quality and pain management following rotator cuff repair. The researchers hypothesize that SlumberCurve™ will significantly improve sleep quality and reduce night-time pain.
详细描述
Poor sleep quality is prevalent among patients undergoing rotator cuff repair surgery, and negatively affects the potential for proper healing. Without adequate sleep, the production of anabolic steroids and inflammatory cytokines are diminished. These anabolic steroids and inflammatory cytokines play a key role in postoperative healing, resulting in adequate pain regulation and increased patient satisfaction. Therefore adequate sleep quality is important not only for quality of life, but for postoperative healing. A recent systematic review revealed that some studies reported varying degrees in both the time and magnitude of change in return to adequate sleep quality following rotator cuff repair. This study hopes to address this gap in the literature by investigating a novel sleep aid, SlumberCurve, and its effect on sleep quality and night-time pain relief. SlumberCurve is a Class I Medical Device and is currently advocated to relieve tension and diminish pain in patients undergoing rotator cuff repair surgery. The device provides adjustable elevation of the torso as well as concave positioning, placing the shoulder in a more forward position. This novel sleep aid has the potential to increase sleep quality, and therefore enhance both patient satisfaction and postoperative recovery from rotator cuff repair surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or nonpregnant female aged 18 years or older with a full-thickness rotator cuff tear undergoing rotator cuff repair surgery
排除标准
- •Patients who receive workers' compensation benefits
- •Patients with irreparable tears
- •Patients undergoing revision surgery
- •Patients with concomitant severe glenohumeral arthritis or concurrent adhesive capsulitis
- •Sleep apnea disorder or other diagnosed sleep disorder
- •Neuropsychiatric disease
- •Use of sleep medication
- •Prior shoulder surgery
- •Rotator cuff arthropathy with pseudo paralysis
- •Acute fractures involving the proximal humerus or shoulder girdle
结局指标
主要结局
Fitbit Sleep Data - Time spent awake, restless, and asleep
时间窗: 90 days
Estimates of time spent awake, restless, and asleep will be assessed. All three measures will be recorded in minutes. Restless sleep indicates movement, and excessive movement will indicates time spent awake.
Postoperative Oral Morphine Equivalents
时间窗: 90 days
Oral morphine equivalents of all opioid-containing medications received
Simple Shoulder Test (SST)
时间窗: 90 days
Function score. Higher score indicates greater function.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 90 days
The PSQI tracks sleep disturbances over time and includes seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleeping medications, and daytime dysfunction. Total of 21 points. Scores of less than 5 indicate adequate sleep. Scores of greater than 5 indicate poor sleep.
Single Assessment Numeric Evaluation (SANE)
时间窗: 90 days
Function score, 0-100%, 100% is best outcome
Fitbit Sleep Data - Sleep Stages
时间窗: 90 days
Sleep stages are estimated by utilizing movement and heart rate variability. Sleep stages are categorized into light sleep, deep sleep, and REM. Collective time spent in each stage will be recorded in minutes.
Visual Analog Scale (VAS)
时间窗: 90 days
Pain score, 0-10, 10 is best outcome
次要结局
未报告次要终点
研究者
Amit Momaya
Assistant Professor, Section Chief, Sports Medicine
University of Alabama at Birmingham