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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to manage pain after rotator cuff surgery using a special cold and compression device (cryo-compression therapy). It compares this method to standard ice packs to determine which better reduces pain, improves quality of life, and decreases the need for pain pills like opioids. Suitable candidates for this trial include individuals with recent or long-term rotator cuff tears requiring surgery who have not found relief from non-surgical treatments. As an unphased trial, it offers patients the chance to explore innovative pain management options that could enhance recovery and reduce reliance on medication.

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 prior data suggests that cryo-compression is safe for post-operative pain control?

Research has shown that cryo-compression therapy is generally safe. This method uses cold and pressure to aid recovery after surgery. Studies have found that it can reduce the need for pain medications like opioids, which is a significant advantage. Although there is a rare risk of cold-related injury, it remains uncommon.

Additional research indicates that cryo-compression does not significantly affect the ability to sense the position of the shoulder joint. Overall, cryo-compression is considered a safe option, especially compared to standard methods like regular ice packs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cryo-compression for rotator cuff injuries because it combines cooling with dynamic compression, a novel approach compared to standard ice pack methods. This treatment uses the NICE Recovery SystemTM, which provides precise temperature control and compression levels, potentially enhancing pain relief and reducing swelling more effectively. Additionally, the ability for patients to adjust the settings after the initial 24 hours allows for a personalized recovery experience, which might lead to faster healing and improved outcomes.

What evidence suggests that cryo-compression is effective for rotator cuff injury?

Research shows that cryo-compression, a treatment in this trial that combines cold and pressure, can greatly reduce pain after shoulder surgery. It also reduces the need for opioid painkillers compared to regular ice wraps. Participants in this trial may receive cryo-compression, which studies have found provides better pain relief and helps maintain shoulder stability after surgery. These findings suggest that cryo-compression might manage pain more effectively than traditional ice packs, used in the cryo-therapy arm of this trial. ^{1 2 4 6 7}

Who Is on the Research Team?

L Pearce McCarty III, MD

Principal Investigator

Allina Health

Are You a Good Fit for This Trial?

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 have a long-term shoulder injury that hasn't improved with treatment.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05095909

Utility of Intermittent Cryo-Compression Versus Traditional ... The purpose of this study is to test the proposed increase efficacy of combining both cold and compression modalities through cryo-compression therapy in post- ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39165152/

Cryo-Pneumatic Compression Results in a Significant ... The use of cryotherapy with pneumatic compression, when compared with standard care, resulted in significantly decreased opioid consumption as well as ...

3. withpower.com withpower.com/trial/phase-rotator-cuff-injuries-9-2021-8b014

Cryo-compression for Rotator Cuff Injury (ICC Trial) Research shows that compressive cryotherapy can reduce postoperative pain in patients undergoing shoulder surgery, and cryotherapy can help stabilize ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3781860/

Cold and compression in the management of ... Findings from randomized controlled trials of knee arthroplasty generally showed cold compression therapy provides better outcomes such as pain relief than ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1360859224003589

The influence of circulating cold water cryotherapy with or ... The small effect sizes observed in our study suggest that cryotherapy is unlikely to have a clinically significant negative effect on shoulder JPS.

6. mdpi.com mdpi.com/2077-0383/13/4/1177

Immediate Effect of Cryo-Compression Therapy on ... This study aimed to assess the effectiveness of cryo-compression (CC) therapy of different times (3 and 6 min) on forearm muscles in MMA fighters.

7. researchgate.net researchgate.net/publication/383275301_Cryo-Pneumatic_Compression_Results_in_a_Significant_Decrease_in_Opioid_Consumption_After_Shoulder_Surgery_A_Multicenter_Randomized_Controlled_Trial

(PDF) Cryo-Pneumatic Compression Results in a ... Previous studies have found a combination of cryotherapy and compression effective at reducing analgesic consumption and increasing recovery in ...