Compression and Cold Therapy on the Post-Operative Shoulder

NCT ID: NCT00703729

Last Updated: 2015-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2014-12-31

Brief Summary

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.

Conditions

Postoperative Pain; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Cold Compression (CC)

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.

Group Type: EXPERIMENTAL

Cold Compression (CC)

Intervention Type: DEVICE

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.

Ice Wrap (IW)

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

Group Type: ACTIVE_COMPARATOR

Ice Wrap (IW)

Intervention Type: OTHER

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.

Interventions

Cold Compression (CC)

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.

Intervention Type: DEVICE

Ice Wrap (IW)

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric C McCarty, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

CU Sports Medicine

Boulder, Colorado, United States

Countries

United States

Other Identifiers

2-5-86058

Identifier Type: -

Identifier Source: secondary_id

07-0403

Identifier Type: -

Identifier Source: org_study_id