The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Patient Reported Pain on Day 2
研究概览
简要总结
The purpose of this study is to evaluate and compare clinical post-operative outcomes for patients using active cooling and compression device and those using ice bags and elastic wrap after acromioplasty or arthroscopic rotator cuff repair.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has undergone unilateral Rotator cuff repair or Acromioplasty
- •Willing to sign a consent form
- •Able to follow study procedures
排除标准
- •Non-ambulatory
- •Participation in concurrent investigational protocol
- •Any bleeding coagulopathies
- •Raynaud's disease or other vasospastic hypersensitivity or circulatory syndromes
- •Hypertension (due to secondary vasoconstriction)
- •Compromised local circulation (including localized compromise due to multiple surgical procedures)
- •A history of vascular impairment (such as frostbite or arterial sclerosis)
- •Cold allergy (cold urticaria) or prior adverse reactions to cold application
- •Rheumatoid arthritis
- •Local limb ischemia
- •Paroxysmal cold hemoglobinuria
- •Cryoglobulinemia or any disease that produces a marked cold pressor response
- •Inflammatory phlebitis
- •Acute inflammations of the veins (thrombophlebitis)
- •Decompensated cardiac insufficiency
- •Arterial dysregulation
- •Erysipelas
- •Deep acute venal thrombosis (phlebothrombosis)
- •Carcinoma and carcinoma metastasis in the affected extremity
- •Decompensated hypertonia
- •Pulmonary embolisms
- •Congestive heart failure
- •Pulmonary edema
- •Suspected deep vein thrombosis
- •Acute inflammatory skin diseases
- •Infection
- •Venous or arterial occlusive disease
结局指标
主要结局
Patient Reported Pain on Day 2
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 3
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 4
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 5
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 6
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 7
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 0
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
Patient Reported Pain on Day 1
时间窗: 1 day
Pain was measured using a visual analog scale (VAS) 10 cm in length, with "no pain" at the left side of the scale and "extreme pain" at the right side. Scores were measured to the closest millimeter for a 0-100 scale.
次要结局
- Use of Pain Medication on Day 1(1 day)
- Use of Pain Medication on Day 2(1 day)
- Use of Pain Medication on Day 3(1 day)
- Use of Pain Medication on Day 4(1 day)
- Use of Pain Medication on Day 5(1 day)
- Use of Pain Medication on Day 6(1 day)
- Use of Pain Medication on Day 7(1 day)