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Completed

NCT Number: NCT00703729

Compression and Cold Therapy on the Post-Operative Shoulder

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.

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Key information

Conditions

Postoperative Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Shoulder Pain Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CU Sports Medicine

Boulder, Colorado, 80304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Compression (CC)

Device

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.

Ice Wrap (IW)

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Use of Pain Medication on Day 1

    Time frame: 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

  2. Use of Pain Medication on Day 2

    Time frame: 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

  3. Use of Pain Medication on Day 3

    Time frame: 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

  4. Use of Pain Medication on Day 4

    Time frame: 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

  5. Use of Pain Medication on Day 5

    Time frame: 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

  6. Use of Pain Medication on Day 6

    Time frame: 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

  7. Use of Pain Medication on Day 7

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2008
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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