90 Participants NeededMy employer runs this trial

Cold and Compression for Postoperative Pain

RH
KB
Overseen ByKen Bode
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of cold and compression therapy in reducing pain after rotator cuff surgery. It compares this method with standard care, which uses pain medication and ice packs. Researchers will monitor pain levels before and after surgery over several months. Individuals scheduled for arthroscopic rotator cuff repair, with high-grade partial or full-thickness tears, and who will receive outpatient physical therapy may be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgery recovery methods.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are using opioids or have certain medical conditions, you may not be eligible to participate.

What prior data suggests that this cold and compression method is safe for postoperative pain management?

Research has shown that cold and compression therapy is generally safe for managing post-surgical pain. Studies have found that patients using cold therapy often report better recovery than those who do not. For instance, one study found that only 12.5% of patients using cold therapy experienced issues in the first 24 hours after surgery, indicating good tolerance for the treatment.

Further research supports that cold and compression therapies help reduce pain and the need for opioid painkillers after surgery, which is important for lowering the risk of side effects from these medications. Cold therapy is considered a safe and affordable option for pain relief.

Overall, evidence suggests that cold and compression therapy is a well-tolerated treatment with few reported side effects.12345

Why are researchers excited about this trial?

Researchers are excited about using cold and compression therapy for postoperative pain because it combines two non-invasive methods to potentially enhance pain relief. Unlike standard care, which typically relies heavily on opioids like hydrocodone/APAP, this approach adds a mechanical element with a cold & compression device. This method might reduce the need for pain medications by providing targeted relief directly at the surgical site, potentially leading to fewer side effects and a lower risk of opioid dependency. By integrating these therapies, the treatment aims to improve recovery experiences and outcomes for patients.

What evidence suggests that cold and compression therapy is effective for postoperative pain?

Research has shown that cold and compression therapy can help reduce pain after surgery. In this trial, one group of participants will receive cold and compression therapy, which studies have shown significantly decreases pain and swelling. For instance, a cold compression device lowered pain levels after knee ligament surgery. Another study found that cold therapy reduced the need for pain medication after shoulder surgery. When combined with compression, cold therapy has also effectively managed pain for patients undergoing total knee replacement surgery. This method offers a simple and effective way to relieve post-surgical pain.36789

Who Is on the Research Team?

MH

Michael Hartman, MD

Principal Investigator

Ochsner Medical Center - Kenner

PP

Paul Phillips, MD

Principal Investigator

Ochsner Medical Center - Kenner

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 35 or older with a high-grade partial or full rotator cuff tear, scheduled for arthroscopic repair by specific doctors at Ochsner Kenner, and able to do rehab at OTW Driftwood. People with certain health issues (like cold allergies, poor circulation, recent opioid use, infections) cannot join.

Inclusion Criteria

English speaking
I am 35 years old or older.
I have a high-grade partial or full rotator cuff tear.
See 2 more

Exclusion Criteria

Opioid use within the last 3 months
I have been diagnosed with Buerger's disease.
I have chilblains (painful red or purple skin patches from cold exposure).
See 42 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgical

Participants are assessed pre-surgically for baseline pain scores

1 week

Post-surgical Treatment

Participants receive either standard care or cold and compression therapy post-surgery

14 days
Daily monitoring

Extended Monitoring

Weekly monitoring of pain scores for 3 months post-surgery

3 months
Weekly visits

Follow-up

Participants are monitored for safety and effectiveness at 6 months post-surgery

6 months
1 visit

What Are the Treatments Tested in This Trial?

Interventions

  • Cold and Compression

Trial Overview

The study compares standard care after rotator cuff surgery to adding cold and compression therapy. Participants are randomly assigned to either group. Pain levels are tracked before surgery and regularly up to six months after surgery.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Cold and CompressionExperimental Treatment1 Intervention
Group II: Standard of Care ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ochsner Health System

Lead Sponsor

Trials
97
Recruited
91,900+

BREG, Inc

Industry Sponsor

Trials
4
Recruited
370+

Citations

The Effect of Cold Application in Postoperative Pain ...

Most studies showed that cold application techniques significantly help reduce postoperative pain and swelling.

Comparing the Effects of Cryotherapy Use and non-use on...

This intervention study aimed to compare the effect of cold compression on post-operative pain in orthopedic patients.

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/28930903/

Effects of Localized Cold Therapy on Pain in Postoperative ...

Background: Cold therapy used in the sports medicine settings has been found to be effective in reducing postoperative pain; however, there are limited studies ...

The Efficacy of Continuous Cold-Therapy on Postoperative ...

The purpose of this study is to determine if postoperative cryotherapy with a cold-therapy system reduces postoperative pain and narcotic consumption

Compressive Cold Application Effect on Pain Level in ...

Application of cold therapy with pressure in a standard protocol has been shown to be an effective method for the treatment of acute pain in TKA patients.

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/36973091/

Effect of Cold Therapy on Managing Postoperative Pain ...

Notably, the cold therapy group had higher recovering quality than the control group. In the first 24 hours, only 4 (12.5%) patients in the cold ...

The effect of cold compress application on pain in post

Cold compresses are thus a viable intervention for pain management following hemorrhoidectomy, though further research with stronger designs and larger sample.

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/34856580/

The Effect of Cryotherapy Application on Postoperative Pain

With moderate certainty evidence, patients treated with cryotherapy experienced a reduction in pain on postoperative day 1 (standardized mean ...

Effectiveness of cryotherapy on pain intensity, range ...

The main findings showed moderate-certainty evidence of a statistically significant difference in favour of the addition of cryotherapy to postoperative ...