Development and Validation of a Digital Pain-Reduction Kit for Musculoskeletal Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- PROMIS - Physical Function Short Form 8b
研究概览
简要总结
This study will test the effectiveness of an evidence-based, multi-modal, "digital pain-reduction kit" as a non-pharmacological supplement to managing patients with pain due to musculoskeletal injuries. Outpatients will be randomized to receive either the pain reduction kit or active control. The kit will contain a virtual reality (VR) headset, therapeutic VR visualization software, and a low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit. Clinical staff will monitor progress and provide scheduled coaching and outreach to patients in the intervention group. The control group will receive the low-cost wearable transcutaneous electrical nerve stimulation (TENS) unit alone; they will not receive VR or remote coaching. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote clinical and technical support. Patients will be followed for 60 days and monitored for functional status, pain levels, use of pain medications (including opioids), satisfaction with care, and time to returning to work.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, age 18 or older
- •Seeking care for a musculoskeletal injury
- •Experiencing pain greater than 3 out of 10 on a visual analog scale
- •English or Spanish speaking
- •Owns a compatible Android or iOS smartphone device (excluding tablets)
排除标准
- •Unable to understand the goals of the study due to cognitive difficulty
- •Use of a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device or high-frequency surgical equipment. (contraindication for TENS units)
- •Pregnant (contraindication for TENS unit)
- •Current diagnosis of epilepsy, dementia, or other neurological disease that may prevent use of VR hardware or software
- •Hypersensitivity to flashing light or motion
- •Injury to the eyes, face, neck, or arms that prevents comfortable use of VR hardware or software, or safe use of other study hardware (e.g., open sores, wounds, or skin rash on face)
结局指标
主要结局
PROMIS - Physical Function Short Form 8b
时间窗: 60 days
PROMIS Physical Function instruments measure self-reported capability rather than actual performance of physical activities. A single Physical Function capability score is obtained from a short form. The forms are universal rather than disease-specific. A higher PROMIS T-score represents more of the concept. For Physical Function, a T-score of 60 is one SD better than average. By comparison, a Physical Function T-score of 40 is one SD worse than average.
次要结局
- PROMIS - Pain Interference Short Form 8a(60 days)
- Patient Satisfaction Questionnaire (PSQ) 18(60 days)
- Binary, Self-reported Opioid Use(60 days)
- Work Productivity and Activity Impairment Questionnaire : Lower Back Pain (WPAI:SHP v2.0)(60 days)
研究者
Brennan Spiegel
Director, Health Services Research
Cedars-Sinai Medical Center