128 Participants Needed

Cooling Therapy for Post-Operative Pain in Carpal Tunnel Syndrome

PN
Overseen ByPatrick Nelson, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Chicago
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12678

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.145910

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

JW

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Ice TherapyExperimental Treatment1 Intervention
Postoperative care with experimental ice therapy
Group II: Standard of Care Ice TherapyActive Control1 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

Find a Clinic Near You

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

References

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]
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]
Preoperative cryotherapy use in anterior cruciate ligament reconstruction. [2022]
A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release. [2019]
[The effect of postoperative cold therapy in joint surgery using a new cooling device]. [2006]
[Cryotherapy]. [2021]
Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. [2005]
The Effect of Cold Therapy Applied to the Incision Area After Abdominal Surgery on Postoperative Pain and Analgesic Use. [2022]
Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. [2022]
A cooling cuff compared to a moist ice pack on radial artery blood flow and lumen diameter in healthy participants. [2022]
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