Compression and Cold Therapy on the Post-Operative Shoulder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00703729
First received: June 19, 2008
Last updated: August 10, 2015
Last verified: August 2015
  Purpose
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 Intervention
Postoperative Pain
Shoulder Pain
Device: Cold Compression (CC)
Other: Ice Wrap (IW)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Patient Reported Pain on Day 0 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:
  • Use of Pain Medication on Day 1 [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Enrollment: 58
Study Start Date: June 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00703729

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     History of Changes
Other Study ID Numbers: 07-0403  2-5-86058 
Study First Received: June 19, 2008
Results First Received: July 15, 2015
Last Updated: August 10, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pain, Postoperative
Shoulder Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Polystyrene sulfonic acid
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 28, 2016