Clinical trial NCT00703729: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Shoulder Pain
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2008-06-23
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Patient Reported Pain on Day 0
timeFrame: 1 day
measure: Patient Reported Pain on Day 1
timeFrame: 1 day
measure: Patient Reported Pain on Day 2
timeFrame: 1 day
measure: Patient Reported Pain on Day 3
timeFrame: 1 day
measure: Patient Reported Pain on Day 4
timeFrame: 1 day
measure: Patient Reported Pain on Day 5
timeFrame: 1 day
measure: Patient Reported Pain on Day 6
timeFrame: 1 day
measure: Patient Reported Pain on Day 7
timeFrame: 1 day
Secondary outcomes:
measure: Use of Pain Medication on Day 1
timeFrame: 1 day
measure: Use of Pain Medication on Day 2
timeFrame: 1 day
measure: Use of Pain Medication on Day 3
timeFrame: 1 day
measure: Use of Pain Medication on Day 4
timeFrame: 1 day
measure: Use of Pain Medication on Day 5
timeFrame: 1 day
measure: Use of Pain Medication on Day 6
timeFrame: 1 day
measure: Use of Pain Medication on Day 7
timeFrame: 1 day
Other outcomes:
Locations:
city: Boulder
country: United States
facility: CU Sports Medicine
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Eric C McCarty, MD
role: PRINCIPAL_INVESTIGATOR
References: