Cryo-compression for Rotator Cuff Injury

(ICC Trial)

Overseen By Ned Tervola, MA, LAT, ATC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Allina Health System

Must not be taking: Opioids

Disqualifiers: Pregnancy, Osteoarthritis, Obesity, Addiction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 62

Duration: 15 days

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Effective post - operative pain control following orthopedic surgical procedures without excessive reliance upon opioid pain medication has garnered increased attention in recent years. This study will evaluate the utilization of a non-invasive, novel cryo - compression, post-operative modality to improve pain control versus standard ice wraps in the immediate post-operative phase of arthroscopic rotator cuff surgery via a randomized controlled study design. Furthermore, if this study demonstrates improved pain control, improved quality of life and decreased opioid usage with the intermittent cold compression unit, recommendations may be considered for system-wide utilization.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using opioid medication.

What data supports the effectiveness of the treatment Cryo-compression for Rotator Cuff Injury?

Research shows that compressive cryotherapy can reduce postoperative pain in patients undergoing shoulder surgery, and cryotherapy can help stabilize inflammation and reduce pain and muscle tension after rotator cuff reconstruction. Additionally, combined cold and compression therapy has been effective in reducing swelling and pain after knee surgery, suggesting potential benefits for similar shoulder injuries. ^{1 2 3 4 5}

Is cryo-compression therapy generally safe for humans?

Cryo-compression therapy is generally considered safe, but there is a rare risk of hypothermic injury if used continuously for long periods, as seen in a case involving an ankle fracture. Most studies report no significant complications when used properly. ^{2 5 6 7 8}

How does cryo-compression treatment differ from other treatments for rotator cuff injury?

Cryo-compression treatment combines cold therapy with compression to reduce pain and swelling more effectively than traditional ice therapy alone. This dual approach can help stabilize inflammation and decrease muscle tension, offering a unique benefit compared to standard ice wraps or cryotherapy used in isolation. ^{1 2 4 5 6}

Research Team

L Pearce McCarty III, MD

Principal Investigator

Allina Health

Eligibility Criteria

This trial is for active patients over 18 with chronic or acute rotator cuff tears who haven't improved with non-surgical treatments and are candidates for arthroscopic repair. It's not suitable for those over 70, pregnant, obese (BMI >45), with a history of drug/alcohol addiction, opioid use, cold-related health issues like Raynaud's disease, significant arthritis in the joint, vascular impairments or lymphedema.

Inclusion Criteria

I recently injured my shoulder's rotator cuff and I'm physically active.

I am a candidate for a shoulder tendon repair surgery.

I am 18 years old or older.

Exclusion Criteria

I have been diagnosed with lymphedema.

Investigators concern regarding subject's ability or willingness to follow protocol

I have a history of substance addiction or am currently using opioids.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative

Pre-operative data collection and informed consent process

1 day

1 visit (in-person)

Treatment

Post-operative cryotherapy using either cryo-compression or standard ice packs

15 days

Daily treatment, 1 visit (in-person) at 2 days post-op

Follow-up

Participants are monitored for pain control, quality of life, and tissue swelling

12 months

Visits at 60 days, 3 months, 6 months, and 12 months

Treatment Details

Interventions

• Cryo-compression
• Cryo-therapy

Trial Overview The study compares two post-operative pain control methods after arthroscopic rotator cuff surgery: a new cryo-compression therapy versus traditional ice wraps. The goal is to see if the novel method can better manage pain and reduce opioid use without side effects. Participants will be randomly assigned to one of these treatments.

Participant Groups

Group I: Cryo-compression Experimental Treatment 1 Intervention

Fitted with compression sleeve for the NICE Recovery SystemTM applied to the operative shoulder immediately post - operatively Minimum 6 hours treatment per day post-operatively. Utilize cyro-compression unit with a "Medium" compression level (inflate to 35 mmHg for 2 minutes and then deflate to 5 mmHg for 30 seconds) and "Level 3" cooling (50F (10C)) for the first 24 hours. After that time, the compression and cooling levels will be up to the patients' discretion.

Group II: Cryo-therapy Active Control 1 Intervention

Fitted with a standard gel ice pack with wrap immediately post-operatively. Minimum 6 hours treatment per day using gel ice packs.

Who Is Running the Clinical Trial?

Allina Health System

Lead Sponsor

Trials

60

Recruited

1,178,000+

Findings from Research

In a study involving 46 patients who underwent shoulder arthroscopy, there was no significant difference in postoperative pain levels or pain medication usage between those using compressive cryotherapy (CC) and those using a standard ice wrap (IW).

The results suggest that compressive cryotherapy may not provide additional benefits over standard ice treatment for managing pain after rotator cuff repair or subacromial decompression, indicating a need for further research on the cost-effectiveness of CC devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. Kraeutler, MJ., Reynolds, KA., Long, C., et al.[2016]

In a study of 30 patients who underwent rotator cuff reconstruction, cryotherapy significantly reduced C-reactive protein (CRP) levels, indicating lower inflammation compared to other interventions.

Cryotherapy also led to notable improvements in muscle tone, particularly in the supraspinatus muscle, suggesting it effectively alleviates pain and muscle tension post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of microcurrent and cryotherapy on C-reactive protein levels and muscle tone of patients with rotator cuff reconstruction. Kang, JI., Jeong, DK., Choi, H.[2020]

Combined cryotherapy and compression (Cryo/Cuff) significantly improved Achilles tendon microcirculation and oxygenation during recovery compared to cryotherapy alone (KoldBlue), as shown in a study with 60 volunteers.

Both treatments reduced blood flow in the tendon initially, but Cryo/Cuff allowed for faster recovery of blood flow and higher tendon oxygen saturation, suggesting it may be more effective for tendon rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Midportion achilles tendon microcirculation after intermittent combined cryotherapy and compression compared with cryotherapy alone: a randomized trial. Knobloch, K., Grasemann, R., Spies, M., et al.[2013]

In a study of 44 participants with acute rotator cuff tendinopathy, both a 2-week gradual reloading exercise program and cryotherapy led to significant improvements in symptoms and function after 2 and 6 weeks.

However, there was no significant difference in effectiveness between the two interventions, suggesting that both approaches can be beneficial for managing acute shoulder pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapy or gradual reloading exercises in acute presentations of rotator cuff tendinopathy: a randomised controlled trial. Dupuis, F., Barrett, E., Dubé, MO., et al.[2022]

In a study of 44 patients undergoing ACL reconstruction, the continuous cooling and compression system (Cryo/Cuff) significantly reduced swelling, pain, and the need for analgesics compared to traditional ice therapy.

Patients using the Cryo/Cuff experienced a greater range of motion (up to 17 degrees more) and improved functional knee scores, highlighting its effectiveness in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of cold and compression after knee surgery. A prospective randomized study. Schröder, D., Pässler, HH.[2019]

In a study of 78 patients undergoing ACL reconstruction, the use of the Cryo/Cuff device did not show significant differences in pain management or recovery outcomes between those using cold water and those using room temperature water, suggesting that the compressive effect may be more important than the cold application.

No complications were reported from using the Cryo/Cuff, indicating it is a safe option for postoperative care, but further research is needed to explore the effects of varying compression levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cold and compression dressings on early postoperative outcomes for the arthroscopic anterior cruciate ligament reconstruction patient. Dervin, GF., Taylor, DE., Keene, GC.[2022]

A rare case of iatrogenic hypothermic injury occurred in a patient after using cryocompression therapy for an ankle fracture, leading to significant soft tissue damage including skin epidermolysis and partial nerve damage.

This incident highlights the potential risks associated with cryocompression therapy, which is commonly used for pain and swelling, suggesting that careful monitoring is necessary to prevent hypothermic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy. Høiness, PR., Hvaal, K., Engebretsen, L.[2005]

Cryotherapy, specifically using cold compression devices, significantly reduces pain scores within 48 hours after ACL reconstruction, based on a meta-analysis of 10 trials involving 573 patients.

There were no differences in the risk of adverse events between patients who received cryotherapy and those who did not, indicating that cryotherapy is safe in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament reconstruction. A systematic review of the literature. Martimbianco, AL., Gomes da Silva, BN., de Carvalho, AP., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. [2016]

2. Japan pubmed.ncbi.nlm.nih.gov

Effects of microcurrent and cryotherapy on C-reactive protein levels and muscle tone of patients with rotator cuff reconstruction. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Midportion achilles tendon microcirculation after intermittent combined cryotherapy and compression compared with cryotherapy alone: a randomized trial. [2013]

4. England pubmed.ncbi.nlm.nih.gov

Cryotherapy or gradual reloading exercises in acute presentations of rotator cuff tendinopathy: a randomised controlled trial. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Combination of cold and compression after knee surgery. A prospective randomized study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of cold and compression dressings on early postoperative outcomes for the arthroscopic anterior cruciate ligament reconstruction patient. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Severe hypothermic injury to the foot and ankle caused by continuous cryocompression therapy. [2005]

8. England pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament reconstruction. A systematic review of the literature. [2022]