Compression and Cold Therapy on the Post-Operative Shoulder

Not Applicable

Completed

Conditions: Postoperative Pain
Shoulder Pain

Registration Number: NCT00703729

Lead Sponsor: University of Colorado, Denver

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient Reported Pain on Day 2	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	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	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	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	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	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	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	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 Outcome Measures

Name	Time	Method
Use of Pain Medication on Day 1	1 day	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	1 day	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	1 day	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	1 day	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	1 day	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	1 day	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	1 day	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