Compression and Cold Therapy on the Post-Operative Shoulder

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Postoperative Pain; Shoulder Pain

Treatments: Other: Ice Wrap (IW); Device: Cold Compression (CC)

Study type: Interventional

Funder types: Other

Identifiers

NCT00703729

07-0403

2-5-86058

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Cold Compression (CC)

Experimental group

Description:

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.

Treatment:

Device: Cold Compression (CC)

Ice Wrap (IW)

Active Comparator group

Description:

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

Treatment:

Other: Ice Wrap (IW)