Status:

COMPLETED

Compression and Cold Therapy on the Post-Operative Shoulder

Lead Sponsor:

University of Colorado, Denver

Conditions:

Postoperative Pain

Shoulder Pain

Eligibility:

All Genders

18-75 years

Phase:

NA

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 acromiopl...

Eligibility Criteria

Inclusion

  • Patient has undergone unilateral Rotator cuff repair or Acromioplasty
  • Willing to sign a consent form
  • Able to follow study procedures

Exclusion

  • 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

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2014

Estimated Enrollment :

58 Patients enrolled

Trial Details

Trial ID

NCT00703729

Start Date

June 1 2008

End Date

December 1 2014

Last Update

September 10 2015

Active Locations (1)

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CU Sports Medicine

Boulder, Colorado, United States, 80304