The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Pain
- Sponsor
- University of Colorado, Denver
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Patient Reported Pain on Day 2
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- 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)
- Use of Pain Medication on Day 6(1 day)
- Use of Pain Medication on Day 7(1 day)