Compression and Cold Therapy on the Post-Operative Shoulder

Postoperative Pain Clinical Trial

Official title:

The Effectiveness of Simultaneous Intermittent Compression and Continuous Cold Therapy on the Post-Operative Shoulder: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703729
• Other study ID #: 07-0403
• Secondary ID: 2-5-86058
• Status: Completed
• Phase: N/A
• First received: June 19, 2008
• Last updated: August 10, 2015
• Start date: June 2008
• Est. completion date: December 2014

Study information

• Verified date: August 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Shoulder Pain

Intervention

Device:
• Cold Compression (CC)
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.

Other:
• Ice Wrap (IW)
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.

Locations

Country	Name	City	State
United States	CU Sports Medicine	Boulder	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Use of Pain Medication on Day 1	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	1 day	No
Secondary	Use of Pain Medication on Day 2	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	1 day	No
Secondary	Use of Pain Medication on Day 3	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	1 day	No
Secondary	Use of Pain Medication on Day 4	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	1 day	No
Secondary	Use of Pain Medication on Day 5	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	1 day	No
Secondary	Use of Pain Medication on Day 6	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	1 day	No
Secondary	Use of Pain Medication on Day 7	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	1 day	No