Cooling Therapy for Post-Operative Pain in Carpal Tunnel Syndrome

Overseen By Patrick Nelson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Opioids, Narcotics

Disqualifiers: Prior surgery, Additional procedures

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 week

128 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

If you are currently using opioid or narcotic pain medications, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of the treatment Cooling Therapy for post-operative pain in Carpal Tunnel Syndrome?

Research shows that controlled cold therapy (CCT) significantly reduces pain, swelling, and the need for pain medication after carpal tunnel surgery compared to standard ice therapy. Additionally, cold therapy is commonly used in other surgeries to reduce pain and swelling, indicating its general effectiveness in post-operative care. ^{1 2 3 4 5}

Is cooling therapy safe for humans?

Cooling therapy, also known as cryotherapy, is generally safe for humans, with complications being extremely rare (about 0.00225%). However, it can cause serious issues like frostbite and chronic pain if not monitored properly, especially in people with risk factors for cold injury. ^{1 2 6 7 8}

How does cooling therapy differ from other treatments for post-operative pain in carpal tunnel syndrome?

Cooling therapy, specifically controlled cold therapy (CCT), is unique because it uses a temperature-controlled cooling blanket that provides more effective pain and swelling reduction compared to traditional ice packs, leading to less need for pain medication. ^{1 4 5 9 10}

What is the purpose of this trial?

This study seeks to perform an appropriately-powered study to evaluate any clinical difference between continuous cooling therapy and traditional ice for treatment of post-operative pain in open CTR surgery.

Research Team

Jennifer Wolf, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for adults over 18 who need open carpal tunnel release surgery and can fill out online questionnaires. It's not for those who've had previous carpal tunnel surgery on the same hand or will have other procedures on either hand, or are currently using opioid pain meds.

Inclusion Criteria

I can and will complete online questionnaires.

I am recommended to have surgery for carpal tunnel syndrome.

Exclusion Criteria

I am currently taking opioid or narcotic pain medication.

I am scheduled for procedures on the same or opposite limb.

I have had carpal tunnel surgery on the same side as my current condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either continuous cooling therapy or traditional ice therapy post-operatively

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using the DASH questionnaire and VAS for pain

1 week

1 visit (virtual)

Treatment Details

Interventions

• Cooling Therapy

Trial Overview The study compares two ways to manage pain after carpal tunnel surgery: a Polarcare Machine that provides continuous cooling therapy versus standard ice packs. The goal is to see which method better reduces post-operative pain.

Participant Groups

Group I: Experimental Ice Therapy Experimental Treatment 1 Intervention

Postoperative care with experimental ice therapy

Group II: Standard of Care Ice Therapy Active Control 1 Intervention

Postoperative care with standard of care ice therapy

Cooling Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cold Therapy for:

• Post-operative pain management
• Acute injuries
• Chronic pain relief

Approved in European Union as Cryotherapy for:

• Post-operative pain management
• Musculoskeletal injuries
• Neuropathic pain

Approved in Canada as Ice Therapy for:

• Post-operative pain management
• Acute injuries
• Sports injuries

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

Cryotherapy, including methods like bagged ice and continuous cryotherapy devices, has been shown to reduce pain and analgesic consumption in about half of the studies reviewed, particularly after orthopedic surgeries, but its effectiveness in improving range of motion and reducing swelling is less clear.

Continuous cryotherapy devices appear to provide better outcomes in terms of pain reduction and recovery after knee arthroscopy compared to traditional ice methods, but more high-quality studies are needed to establish their superiority and safety as a standard treatment in orthopedic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. Kunkle, BF., Kothandaraman, V., Goodloe, JB., et al.[2023]

In a study of 37 patients who underwent total knee arthroplasty, the pleasant sensation from icing either the knee or the hand significantly reduced pain intensity during knee flexion, indicating that the sensation itself may play a key role in pain management.

The location of icing (knee vs. hand) did not significantly affect pain levels, suggesting that even distant icing (like on the hand) could be beneficial for pain relief after knee surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pleasant Sensation Evoked by Knee or Hand Icing Influences the Effect on Pain Intensity in Patients After Total knee Arthroplasty: A Prospective, Randomized, Cross-Over Study. Nishigami, T., Nakao, S., Kondo, H., et al.[2022]

In a study of 53 patients undergoing ACL reconstruction, those who received preoperative cryotherapy reported significantly lower pain scores and used less narcotic medication in the first 36 hours post-surgery compared to those who did not receive cryotherapy.

The findings suggest that preoperative cryotherapy is a safe and effective addition to multimodal pain management strategies, potentially improving recovery outcomes after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative cryotherapy use in anterior cruciate ligament reconstruction. Koyonos, L., Owsley, K., Vollmer, E., et al.[2022]

In a study of 72 patients recovering from carpal tunnel surgery, controlled cold therapy (CCT) was found to significantly reduce pain, swelling, and narcotic use compared to traditional ice therapy by postoperative day 3.

Patients using CCT reported greater comfort and required fewer narcotics, suggesting that CCT may be a more effective postoperative treatment option for managing pain and edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release. Hochberg, J.[2019]

In a study involving 10 patients recovering from various knee surgeries, continuous cold therapy using a new cooling device significantly reduced pain, with 8 out of 10 patients reporting little to no pain compared to a control group.

The therapy was particularly effective in reducing swelling and effusion after arthroscopic procedures and provided substantial pain relief after arthrotomy, leading to a positive overall experience for the patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of postoperative cold therapy in joint surgery using a new cooling device]. Münst, P., Bonnaire, F., Kuner, EH.[2006]

Local cryotherapy, such as using cold packs or sprays, effectively reduces pain and swelling in patients with inflammatory conditions and injuries, making it a useful treatment option.

Whole body cryotherapy at extremely low temperatures (-110 degrees C) has shown some pain-relieving effects, but the high rate of adverse events and limited data do not justify its routine use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cryotherapy]. Hermann, J.[2021]

Continuous-flow cryotherapy units effectively reduce pain, inflammation, swelling, blood loss, and the need for narcotics after surgery, making them a beneficial postoperative treatment option.

While complications from cryotherapy are very rare (about 0.00225%), they can be serious, so it's important to monitor patients closely for signs of cold injury, especially those with known risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Wilke, B., Weiner, RD.[2005]

In a randomized controlled trial involving 60 patients after abdominal surgery, cold therapy applied to the incision area significantly reduced pain levels compared to the control group, particularly after the therapy was administered at postoperative hours 1, 2, and 8.

Despite the effective pain reduction observed with cold therapy, there was no significant difference in the use of analgesics between the experimental and control groups, suggesting that while cold therapy helps manage pain, it does not reduce the need for pain medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Cold Therapy Applied to the Incision Area After Abdominal Surgery on Postoperative Pain and Analgesic Use. Ozkan, B., Cavdar, I.[2022]

In a study of 39 patients who underwent ACL reconstruction, dynamic intermittent compression combined with cryotherapy significantly reduced the need for analgesic drugs compared to static compression, with a notable decrease in tramadol and morphine usage.

Patients receiving dynamic compression also achieved better knee flexion at discharge, with an average of 90.5° compared to 84.5° for those with static compression, indicating improved postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Murgier, J., Cassard, X.[2022]

A study comparing a novel cooling cuff to traditional moist ice therapy found that both methods significantly reduced radial artery blood flow after 15 minutes, indicating their effectiveness in managing inflammation and pain in acute injuries.

There were no significant differences in the effects on blood flow or artery diameter between the cooling cuff and moist ice, suggesting that the cooling cuff can be a viable alternative for treating post-traumatic injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cooling cuff compared to a moist ice pack on radial artery blood flow and lumen diameter in healthy participants. Gernetzky, J., O'Connor, L., Varatharajullu, D., et al.[2022]

References

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

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

A Pleasant Sensation Evoked by Knee or Hand Icing Influences the Effect on Pain Intensity in Patients After Total knee Arthroplasty: A Prospective, Randomized, Cross-Over Study. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Preoperative cryotherapy use in anterior cruciate ligament reconstruction. [2022]

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

A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release. [2019]

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

[The effect of postoperative cold therapy in joint surgery using a new cooling device]. [2006]

6. Germany pubmed.ncbi.nlm.nih.gov

[Cryotherapy]. [2021]

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

Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. [2005]

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

The Effect of Cold Therapy Applied to the Incision Area After Abdominal Surgery on Postoperative Pain and Analgesic Use. [2022]

9. France pubmed.ncbi.nlm.nih.gov

Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. [2022]

10. South Africa pubmed.ncbi.nlm.nih.gov

A cooling cuff compared to a moist ice pack on radial artery blood flow and lumen diameter in healthy participants. [2022]