Compression and Cold Therapy on the Post-Operative Shoulder

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial

Conditions
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Postoperative Pain, Shoulder Pain

Intervention / Treatment
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* Device: Cold Compression (CC)
* Other: Ice Wrap (IW)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has undergone unilateral Rotator cuff repair or Acromioplasty Willing to sign a consent form Able to follow study procedures Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cold Compression (CC)<br>The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period. | Device: Cold Compression (CC)<br>* The device is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The device will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours.<br>|
| Active Comparator: Ice Wrap (IW)<br>The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period | Other: Ice Wrap (IW)<br>* The ice bag is applied to the shoulder within 60 minutes of arrival to the recovery room following surgery. The ice bag is placed on the shoulder and the elastic wrap is used to hold the bag in place. The ice will be applied at one hour intervals (60 minutes on the shoulder, 60 minutes off) during waking hours for the first 72 hours after surgery. For the remainder of the study period, therapy will be applied for one hour treatments 2-3 times a day during waking hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Pain on Day 0 | 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. | 1 day | 
| Patient Reported Pain on Day 1 | 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. | 1 day | 
| Patient Reported Pain on Day 2 | 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. | 1 day | 
| Patient Reported Pain on Day 3 | 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. | 1 day | 
| Patient Reported Pain on Day 4 | 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. | 1 day | 
| Patient Reported Pain on Day 5 | 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. | 1 day | 
| Patient Reported Pain on Day 6 | 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. | 1 day | 
| Patient Reported Pain on Day 7 | 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of Pain Medication on Day 1 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day | 
| Use of Pain Medication on Day 2 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day | 
| Use of Pain Medication on Day 3 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day | 
| Use of Pain Medication on Day 4 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day | 
| Use of Pain Medication on Day 5 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day | 
| Use of Pain Medication on Day 6 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day | 
| Use of Pain Medication on Day 7 | Pain medication was quantified using a morphine equivalent dosage (MED) with the following scale: 1 mg of oral morphine = 1 morphine equivalent. 3 mg morphine = 3 mg hydrocodone = 2 mg oxycodone | 1 day |