Compression and Cold Therapy on the Post-Operative Shoulder
The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial
2 other identifiers
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable postoperative-pain
Started Jun 2008
Longer than P75 for not_applicable postoperative-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 19, 2008
CompletedFirst Posted
Study publicly available on registry
June 23, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedResults Posted
Study results publicly available
September 10, 2015
CompletedSeptember 10, 2015
August 1, 2015
6.5 years
June 19, 2008
July 15, 2015
August 10, 2015
Conditions
Outcome Measures
Primary Outcomes (8)
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
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.
1 day
Secondary Outcomes (7)
Use of Pain Medication on Day 1
1 day
Use of Pain Medication on Day 2
1 day
Use of Pain Medication on Day 3
1 day
Use of Pain Medication on Day 4
1 day
Use of Pain Medication on Day 5
1 day
- +2 more secondary outcomes
Study Arms (2)
Cold Compression (CC)
EXPERIMENTALThe 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.
Ice Wrap (IW)
ACTIVE COMPARATORThe 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
Interventions
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.
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 Criteria
You may qualify if:
- Patient has undergone unilateral Rotator cuff repair or Acromioplasty
- Willing to sign a consent form
- Able to follow study procedures
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CU Sports Medicine
Boulder, Colorado, 80304, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Some patients were removed from the trial due to non-compliance, most commonly for failing to complete the pain diaries. There is also some inherent recall bias in asking a patient to fill out a diary.
Results Point of Contact
- Title
- Dr. Eric McCarty
- Organization
- CU Sports Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Eric C McCarty, MD
University of Colorado, Denver
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 19, 2008
First Posted
June 23, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 10, 2015
Results First Posted
September 10, 2015
Record last verified: 2015-08