Cooling Therapy for Post-Operative Pain in Carpal Tunnel Syndrome
Recruiting in Palo Alto (17 mi)
Overseen byJennifer Wolf, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Chicago
Must not be taking: Opioids, Narcotics
Disqualifiers: Prior surgery, Additional procedures
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
12678How 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.
145910Eligibility 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 am 18 years old or older.
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.
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Chicago MedicineChicago, IL
Loading ...
Who Is Running the Clinical Trial?
University of ChicagoLead Sponsor
References
Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. [2023]Cold therapy, also known as cryotherapy, includes the use of bagged ice, ice packs, compressive cryotherapy devices, or whole-body cryotherapy chambers. Cryotherapy is commonly used in postoperative care for both arthroscopic and open orthopaedic procedures.
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]Cold therapy on the operated area after surgery is often used as an analgesic and to reduce pain, swelling, and increase range of motion. However, evidence to support the results of cold therapy is still scarce and the mechanism underlying its effectiveness remains unclear. The present study aimed to investigate whether a pleasant sensation evoked by icing the treated knee or a site distant from the treated site (the hand) influenced the acute effect on pain intensity in patients who have undergone total knee arthroplasty (TKA).
Preoperative cryotherapy use in anterior cruciate ligament reconstruction. [2022]Unrelieved postoperative pain may impair rehabilitation, compromise functional outcomes, and lead to patient dissatisfaction. Preemptive multimodal analgesic techniques may improve outcomes after surgery. We hypothesized that patients using preoperative cryotherapy plus a standardized postoperative treatment plan will have lower pain scores and require less pain medication compared with patients receiving a standardized postoperative treatment plan alone after arthroscopically assisted anterior cruciate ligament reconstruction (ACLR). A total of 53 consecutive patients undergoing arthroscopically assisted ACLR performed by one of seven surgeons were randomly assigned to one of two groups. Group 1 received no preoperative cryotherapy and group 2 received 30 to 90 minutes of preoperative cryotherapy to the operative leg using a commercial noncompressive cryotherapy unit. Visual analog scale pain scores and narcotic use were recorded for the first 4 days postoperatively. Total hours of cold therapy and continuous passive motion (CPM) use and highest degree of flexion achieved were recorded as well. Group 1 consisted of 26 patients (15 allograft Achilles tendon and 11 autograft bone patellar tendon bone [BPTB]), and group 2 consisted of 27 patients (16 allograft Achilles tendon and 11 autograft BPTB). Group 2 patients reported less pain (average 1.3 units, p
A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release. [2019]A prospective randomized study was performed comparing the efficacy of controlled cold therapy (CCT) with the efficacy of ice therapy in the postoperative treatment of 72 patients with carpal tunnel syndrome. Immediately after surgery, patients applied either a temperature-controlled cooling blanket (CCT) or a standard ice pack over their surgical dressings. Pain was assessed by visual analog scale and swelling by wrist circumference preoperatively, immediately after surgery, and on postoperative day 3. Patients kept log books of daily treatment times. Narcotic use (of Vicodin ES) was determined by pill count at day 3 and by daily log book recordings. Patients who used CCT showed significantly greater reduction in pain, edema (wrist circumference), and narcotic use at postoperative day 3 than did those using ice therapy. This study indicates that after carpal tunnel surgery, the use of CCT, compared with traditional ice therapy, provides patients with greater comfort and lessens the need for narcotics.
[The effect of postoperative cold therapy in joint surgery using a new cooling device]. [2006]The effect of continuous cold therapy with a new cooling device in post-operative treatment after knee surgery has been proved. Ten patients with different operations of the knee joint participated in this study. Eight out of ten patients reported no or poor pain, whereas in the control group especially after arthrotomy considerable or violent pain was reported. After arthroscopic operations we found more an decrease of swelling and effusion, after arthrotomy more pain reduction. The subjective feeling of all patients was very good and they were generally very receptive to it.
[Cryotherapy]. [2021]Cryotherapy is a form of physical therapy that can be applied locally and systemically. Local cryotherapy administered for instance as cold packs, cold air or sprays lowers skin and tissue temperature and subsequently decreases neuronal activity and tissue blood flow. In clinical trials cryotherapy showed analgetic effects and reduced local edema; this treatment is therefore an option in patients with painful and inflammatory rheumatic diseases and after traumatic injuries.Only scant experimental and clinical data are available for whole body cryotherapy at -110 degrees C. The analgetic effects demonstrated so far and the high percentage of adverse events observed with this challenging method currently do not support its routine use in clinical practice.
Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. [2005]Continuous-flow cryotherapy units have been proved to decrease pain, inflammation, swelling, blood loss, and narcotic usage in the postoperative setting. Complications related to cryotherapy are extremely rare (estimated at 0.00225%) but can be devastating. Complications include frostbite, chronic pain, and loss of digits. Caution should be exercised when prescribing continuous-flow cryotherapy units to patients with known risk factors for cold injury. All members involved with care of the patient, including the physician, nursing staff, patient, and patient's family and caregivers, should take an active roll in monitoring the foot for signs and symptoms of cold injury. Continuous-flow cold therapy should be discontinued when capillary refill time is greater than 5 seconds.
The Effect of Cold Therapy Applied to the Incision Area After Abdominal Surgery on Postoperative Pain and Analgesic Use. [2022]Cold therapy is one of the most common nonpharmacologic pain treatments. Despite the existence of many studies about cold therapy, few have examined the effects of cold therapy after abdominal surgery.
Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. [2022]Cryotherapy is a useful adjunctive analgesic measure in patients with postoperative pain following anterior cruciate ligament (ACL) surgery. Either static permanent compression or dynamic intermittent compression can be added to increase the analgesic effect of cryotherapy. Our objective was to compare the efficacy of these two compression modalities combined with cryotherapy in relieving postoperative pain and restoring range of knee motion after ligament reconstruction surgery.
A cooling cuff compared to a moist ice pack on radial artery blood flow and lumen diameter in healthy participants. [2022]Cryotherapy is a favourable treatment for post-traumatic injuries in the acute stage because of its effect on inflammation and pain. A novel cooling cuff, which can be easily used and can be wrapped around the injured area that does not require freezing, has been developed. Its efficacy compared to traditional ice therapy has not been established.