NCT07516327招募中不适用
Cold and Compression After Rotator Cuff Repair or Arthroscopic Rotator Cuff Repair Pain Attenuation: A Randomized, Controlled Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- PROMIS Pain NRS subscale
研究概览
简要总结
The purpose of this study is to compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups pre-surgically, daily after surgery for 14 days, then weekly after surgery for 3 months, and at 6 months post-surgery.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 35 yr or older
- •Patient of Drs. Michael Hartman (PI), Ian Elliott, Jay French, or Paul Phillips at Ochsner Kenner scheduled for arthroscopic rotator cuff repair
- •Will receive outpatient physical therapy at OTW Driftwood for the entire post-op rehabilitation period
- •English speaking
- •Diagnosis of high-grade partial or full thickness rotator cuff tears
排除标准
- •Chronic opioid use
- •Opioid use within the last 3 months
- •Diagnosis of inflammatory disease process (i.e., gout, rheumatoid arthritis, systematic lupus erythematosus...)
- •Discharge to skilled nursing
- •Cold intolerance related to diseases, like Raynaud's
- •Significant vascular impairment in the affected region
- •Current clinical signs of inflammatory phlebitis, venous ulcers, or cellulitis
- •Significant risk factors or current clinical signs of embolism (e.g., pulmonary embolus, pulmonary edema, cerebral infarction, atrial fibrillation, endocarditis, myocardial infarction, or atheromatous embolic plaque)
- •A condition in which increased venous or lymphatic return is not desired in the affected extremity (e.g., lymphedema after breast cancer or other local carcinoma and/or carcinoma metastasis in the affected extremity).
- •Uncontrolled hypertension (physician discretion), cardiac failure, extreme low blood pressure, or decompensated cardiac insufficiency.
- •Localized unstable skin condition (e.g., dermatitis, vein ligation, gangrene, or recent skin graft) in the affected region.
- •Had recent toe surgery in the affected region
- •Current clinical signs in the affected region of significant peripheral edema (e.g., deep vein thrombosis, chronic venous insufficiency, acute compartment syndrome, systemic venous hypertension, congestive heart failure, cirrhosis/liver failure, renal failure).
- •An acute, unstable (untreated) fracture in the affected region.
- •Any active local or systemic infection.
- •Obtunded or with diabetes mellitus, multiple sclerosis, poor circulation, spinal cord injuries, and rheumatoid arthritis
- •Areas of skin breakdown or damage (damaged or at-risk skin) producing uneven heat conduction across the skin (e.g., open wound, scar tissue, burn or skin graft). Any open wound must be dressed prior to use of the Polar Care Wave System.
- •Presumptive evidence of congestive heart failure
- •Pre-existing DVT condition
- •Deep acute venal thrombosis (Phlebothrombosis)
- •Episodes of pulmonary embolism
- •Pulmonary edema
- •Acute inflammation of the veins (Thrombophlebitis)
- •Decompensated cardiac insufficiency
- •Arterial dysregulation
- •Carcinoma and carcinoma metastasis in the affected extremity
- •Decompensated hypertonia
- •Acute inflammatory skin diseases or infection
- •Venous or arterial occlusive disease
- •Medical situations where increased venous or lymphatic return is undesirable
- •Poor peripheral circulation
- •Severe arteriosclerosis, or active infection
- •Known hematological dyscrasias that predispose to thrombosis (e.g., paroxysmal cold hemoglobinuria, cryoglobulinemia, sicklecell disease, serum cold agglutinins).
- •Tissues inflamed as a result of recent injury or exacerbation of chronic inflammatory condition.
- •Compromised local circulation or neurologic impairment (including paralysis or localized compromise due to multiple surgical procedures or diabetes) in the affected region.
- •Cognition or communication impairments that prevent them from giving accurate and timely feedback.
- •Cold allergy
- •Cold agglutinin disorders like paroxysmal cold hemoglobinuria
- •Buerger's disease
- •Cryoglobulinemia
- •Sickle cell anemia
- •Uncontrolled diabetes (physician discretion)
- •Hypersensitivity to cold
研究组 & 干预措施
Standard of Care Arm
Active Comparator
Patients in this arm will receive standard therapy post-surgery and discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold therapy (bag of ice or gel pack)
干预措施: SOC (Standard of care) (Other)
Cold and Compression
Experimental
Patients in this arm will be discharged with 28 hydrocodone/APAP 7.5 mg pills taken every 6 hours as needed (or its MME equivalent), 1 identical refill if patient calls, and cold & compression therapy device provided by Sponsor)
干预措施: Cold and Compression (Device)
结局指标
主要结局
PROMIS Pain NRS subscale
时间窗: Enrollment to 6 months post RCR
Compare pain score (Patient-Reported Outcomes Measurement Information System: PROMIS NRS Pain Subscale) between the control and cold/compression groups
次要结局
未报告次要终点
研究者
研究点 (1)
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