An interventional study of Cold Compression (CC) and Ice Wrap (IW) in Postoperative Pain and Shoulder Pain, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-09-10.
Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Supportive care
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 58 is close to the median of 60 across 561 interventional studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Cold Compression (CC)
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
Other: Ice Wrap (IW)
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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Started | 25 | 24 |
| Completed | 25 | 21 |
| Not completed | 0 | 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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 0 | 30.2 ± 34.3 | 24.2 ± 30.0 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 1 | 38.6 ± 20.4 | 37.3 ± 25.2 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 1 | 38.8 ± 24.4 | 47.4 ± 29.2 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 2 | 34.5 ± 19.2 | 36.5 ± 29.1 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 3 | 30.1 ± 19.5 | 33.2 ± 27.8 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 4 | 30.6 ± 26.3 | 33.5 ± 24.5 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 5 | 23.4 ± 19.2 | 28.0 ± 27.1 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 6 | 27.3 ± 22.8 | 26.0 ± 26.2 |
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.
| Visual Analog Score (0-100) | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Patient Reported Pain on Day 7 | 24.8 ± 19.9 | 23.0 ± 27.7 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 2 | 38.0 ± 28.7 | 33.2 ± 25.1 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 3 | 30.5 ± 29.8 | 28.9 ± 25.6 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 4 | 22.8 ± 29.6 | 14.3 ± 16.5 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 5 | 18.9 ± 27.9 | 11.0 ± 14.1 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 6 | 18.1 ± 26.0 | 7.7 ± 12.0 |
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
| Morphine Equivalent Dosage | Cold Compression (CC) | Ice Wrap (IW) |
|---|---|---|
| Use of Pain Medication on Day 7 | 11.8 ± 16.7 | 6.3 ± 11.5 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cold Compression (CC) | — | 0/25 (0%) | 0/25 (0%) |
| Ice Wrap (IW) | — | 0/24 (0%) | 0/24 (0%) |
| Age, Continuous(years) | Cold Compression (CC) | Ice Wrap (IW) | Total |
|---|---|---|---|
| Mean | 55.4 ± 10.6 | 55.8 ± 11.2 | 55.6 ± 10.8 |
| Sex: Female, Male(Participants) | Cold Compression (CC) | Ice Wrap (IW) | Total |
|---|---|---|---|
| Female | 13 | 8 | 21 |
| Male | 12 | 16 | 28 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Colorado, Denver