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Compression and Cold Therapy on the Post-Operative Shoulder

Primary Purpose

Postoperative Pain, Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cold Compression (CC)
Ice Wrap (IW)
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CU Sports Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cold Compression (CC)

Ice Wrap (IW)

Arm 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.

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

Outcomes

Primary Outcome Measures

Patient Reported Pain on Day 0
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Full Information

First Posted
June 19, 2008
Last Updated
August 10, 2015
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT00703729
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Shoulder Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cold Compression (CC)
Arm Type
Experimental
Arm 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.
Arm Title
Ice Wrap (IW)
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
Cold Compression (CC)
Intervention Description
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
Other
Intervention Name(s)
Ice Wrap (IW)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Reported Pain on Day 0
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 1
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 2
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 3
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 4
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 5
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 6
Description
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.
Time Frame
1 day
Title
Patient Reported Pain on Day 7
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Use of Pain Medication on Day 1
Description
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
Time Frame
1 day
Title
Use of Pain Medication on Day 2
Description
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
Time Frame
1 day
Title
Use of Pain Medication on Day 3
Description
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
Time Frame
1 day
Title
Use of Pain Medication on Day 4
Description
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
Time Frame
1 day
Title
Use of Pain Medication on Day 5
Description
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
Time Frame
1 day
Title
Use of Pain Medication on Day 6
Description
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
Time Frame
1 day
Title
Use of Pain Medication on Day 7
Description
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
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric C McCarty, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
CU Sports Medicine
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States

12. IPD Sharing Statement

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Compression and Cold Therapy on the Post-Operative Shoulder

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