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

Tracking Information

• First Submitted Date: June 19, 2008
• First Posted Date: June 23, 2008
• Results First Submitted Date: July 15, 2015
• Results First Posted Date: September 10, 2015
• Last Update Posted Date: September 10, 2015
• Study Start Date: June 2008
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 10, 2015)

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Primary Outcome Measures (submitted: June 20, 2008): Patient reported pain [ Time Frame: 15 days ]

Current Secondary Outcome Measures (submitted: August 10, 2015)

• 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
• 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
• 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
• 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
• 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
• 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
• 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

• Original Secondary Outcome Measures (submitted: June 20, 2008): Use of pain medication [ Time Frame: 15 days ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Compression and Cold Therapy on the Post-Operative Shoulder
• Official Title: The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Postoperative Pain
• Shoulder Pain

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Device: Cold Compression (CC)
• 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
  Intervention: Other: Ice Wrap (IW)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 1, 2014): 58
• Original Estimated Enrollment (submitted: June 20, 2008): 80
• Actual Study Completion Date: December 2014
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00703729
• Other Study ID Numbers: 07-0403; 2-5-86058
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Colorado, Denver
• Original Responsible Party: Eric C. McCarty, MD, University of Colorado at Denver and Health Sciences Center
• Current Study Sponsor: University of Colorado, Denver
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Colorado, Denver
• Verification Date: August 2015