Postoperative Pain, Shoulder Pain
Conditions
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.
Interventions
DEVICECold 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.
OTHERIce 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.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cold Compression (CC) The Game Ready device provides both active, continuous cold and intermittent, pneumatic compression to the post-op shoulder. The first group will use the Game Ready™ Device (CC) for one week following surgery and will use standard ice bags wrapped to the shoulder (IW) for the remainder of the study period.
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. | 25 |
| Ice Wrap (IW) The ice bag (IW)is secured to the shoulder using an elastic wrap. The second group will use standard ice bags wrapped to the shoulder (IW) for one week following surgery and will use the Game Ready™ Device (CC) for the remainder of the study period
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. | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | Cold Compression (CC) | Ice Wrap (IW) | Total |
|---|---|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 10.6 | 55.8 years STANDARD_DEVIATION 11.2 | 55.6 years STANDARD_DEVIATION 10.8 |
| Sex: Female, Male Female | 13 Participants | 8 Participants | 21 Participants |
| Sex: Female, Male Male | 12 Participants | 16 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 0 | 30.2 Visual Analog Score (0-100) | Standard Deviation 34.3 |
| Ice Wrap (IW) | Patient Reported Pain on Day 0 | 24.2 Visual Analog Score (0-100) | Standard Deviation 30 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 1 | 38.8 Visual Analog Score (0-100) | Standard Deviation 24.4 |
| Ice Wrap (IW) | Patient Reported Pain on Day 1 | 47.4 Visual Analog Score (0-100) | Standard Deviation 29.2 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 2 | 34.5 Visual Analog Score (0-100) | Standard Deviation 19.2 |
| Ice Wrap (IW) | Patient Reported Pain on Day 2 | 36.5 Visual Analog Score (0-100) | Standard Deviation 29.1 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 3 | 30.1 Visual Analog Score (0-100) | Standard Deviation 19.5 |
| Ice Wrap (IW) | Patient Reported Pain on Day 3 | 33.2 Visual Analog Score (0-100) | Standard Deviation 27.8 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 4 | 30.6 Visual Analog Score (0-100) | Standard Deviation 26.3 |
| Ice Wrap (IW) | Patient Reported Pain on Day 4 | 33.5 Visual Analog Score (0-100) | Standard Deviation 24.5 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 5 | 23.4 Visual Analog Score (0-100) | Standard Deviation 19.2 |
| Ice Wrap (IW) | Patient Reported Pain on Day 5 | 28.0 Visual Analog Score (0-100) | Standard Deviation 27.1 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 6 | 27.3 Visual Analog Score (0-100) | Standard Deviation 22.8 |
| Ice Wrap (IW) | Patient Reported Pain on Day 6 | 26.0 Visual Analog Score (0-100) | Standard Deviation 26.2 |
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.
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Patient Reported Pain on Day 7 | 24.8 Visual Analog Score (0-100) | Standard Deviation 19.9 |
| Ice Wrap (IW) | Patient Reported Pain on Day 7 | 23.0 Visual Analog Score (0-100) | Standard Deviation 27.7 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 1 | 38.6 Morphine Equivalent Dosage | Standard Deviation 20.4 |
| Ice Wrap (IW) | Use of Pain Medication on Day 1 | 37.3 Morphine Equivalent Dosage | Standard Deviation 25.2 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 2 | 38.0 Morphine Equivalent Dosage | Standard Deviation 28.7 |
| Ice Wrap (IW) | Use of Pain Medication on Day 2 | 33.2 Morphine Equivalent Dosage | Standard Deviation 25.1 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 3 | 30.5 Morphine Equivalent Dosage | Standard Deviation 29.8 |
| Ice Wrap (IW) | Use of Pain Medication on Day 3 | 28.9 Morphine Equivalent Dosage | Standard Deviation 25.6 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 4 | 22.8 Morphine Equivalent Dosage | Standard Deviation 29.6 |
| Ice Wrap (IW) | Use of Pain Medication on Day 4 | 14.3 Morphine Equivalent Dosage | Standard Deviation 16.5 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 5 | 18.9 Morphine Equivalent Dosage | Standard Deviation 27.9 |
| Ice Wrap (IW) | Use of Pain Medication on Day 5 | 11.0 Morphine Equivalent Dosage | Standard Deviation 14.1 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 6 | 18.1 Morphine Equivalent Dosage | Standard Deviation 26 |
| Ice Wrap (IW) | Use of Pain Medication on Day 6 | 7.7 Morphine Equivalent Dosage | Standard Deviation 12 |
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
Time frame: 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cold Compression (CC) | Use of Pain Medication on Day 7 | 11.8 Morphine Equivalent Dosage | Standard Deviation 16.7 |
| Ice Wrap (IW) | Use of Pain Medication on Day 7 | 6.3 Morphine Equivalent Dosage | Standard Deviation 11.5 |