Compression and Cold Therapy on the Post-Operative Shoulder

• ClinicalTrials.gov Identifier: NCT00703729
• Recruitment Status: Completed
• First Posted: June 23, 2008
• Results First Posted: September 10, 2015
• Last Update Posted: September 10, 2015
• Sponsor: University of Colorado, Denver
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain; Shoulder Pain	Device: Cold Compression (CC); Other: Ice Wrap (IW)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial
• Study Start Date: June 2008
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: 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.
Active Comparator: 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	Other: 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.

Outcome Measures

Primary Outcome Measures :

1. Patient Reported Pain on Day 0 [ Time Frame: 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.
2. Patient Reported Pain on Day 1 [ Time Frame: 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.
3. Patient Reported Pain on Day 2 [ Time Frame: 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.
4. Patient Reported Pain on Day 3 [ Time Frame: 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.
5. Patient Reported Pain on Day 4 [ Time Frame: 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.
6. Patient Reported Pain on Day 5 [ Time Frame: 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.
7. Patient Reported Pain on Day 6 [ Time Frame: 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.
8. Patient Reported Pain on Day 7 [ Time Frame: 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.

Secondary Outcome Measures :

1. Use of Pain Medication on Day 1 [ Time Frame: 1 day ]
   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
2. Use of Pain Medication on Day 2 [ Time Frame: 1 day ]
   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
3. Use of Pain Medication on Day 3 [ Time Frame: 1 day ]
   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
4. Use of Pain Medication on Day 4 [ Time Frame: 1 day ]
   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
5. Use of Pain Medication on Day 5 [ Time Frame: 1 day ]
   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
6. Use of Pain Medication on Day 6 [ Time Frame: 1 day ]
   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
7. Use of Pain Medication on Day 7 [ Time Frame: 1 day ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Colorado

CU Sports Medicine

Boulder, Colorado, United States, 80304

Sponsors and Collaborators

University of Colorado, Denver

Investigators

• Principal Investigator: Eric C McCarty, MD; University of Colorado, Denver

More Information

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00703729
• Other Study ID Numbers: 07-0403; 2-5-86058
• First Posted: June 23, 2008
• Results First Posted: September 10, 2015
• Last Update Posted: September 10, 2015
• Last Verified: August 2015

Additional relevant MeSH terms:

Shoulder Pain; Pain; Neurologic Manifestations; Arthralgia; Joint Diseases; Musculoskeletal Diseases