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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.
Post-operative pain control is paramount to all operative procedures and involves several modalities. Both pharmaceutical and non-pharmaceutical measures are frequently used. Carpal tunnel release (CTR) surgery is one of the most common surgeries performed in the U.S. with over 400,000 procedures per year.2 Frequently, ice is used as a treatment modality following surgical CTR.3 Several products have been developed in the past decades to improve ice therapy in the rehabilitation period. One such product is the Polar Care which provides up to 6-8 hours of continuous icing.
While there is good data supporting the use of cooling therapy (ice) for post-operative pain, there is lack of data surrounding the use of continuous cooling therapy machines such as the PolarCare following carpal tunnel release (CTR). The two papers that evaluated the efficacy of continuous cooling therapy following CTR had conflicting results on any added benefit of continuous cooling therapy over traditional icing.
There is no standard of care for post-operative icing at UCMC following CTR. Clinicians currently decide whether to give patients a PolarCare machine on the day of surgery without any algorithm. All other patients are encouraged to use traditional icing methods. 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.
The investigators hypothesize that participants receiving continuous cooling therapy will have a statistically significantly lower pain score compared to those receiving traditional ice therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Ice Therapy | Experimental | Postoperative care with experimental ice therapy |
|
| Standard of Care Ice Therapy | Active Comparator | Postoperative care with standard of care ice therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polarcare Machine | Other | Use of Polar Care ice machine as often as possible, but a minimum of three 15 minute uses per day, for the first 3 days after surgery. No single use should last longer than 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) for pain | The visual analog scale for pain is a straight line with one end meaning no pain and the other end meaning the worst pain imaginable. A patient marks a point on the line that matches the amount of pain he or she feels. | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disabilities of the Arm, Shoulder, and Hand questionnaire | he DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Nelson, MD | Contact | 773-834-3531 | Patrick.Nelson@uchospitals.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer Wolf, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Medicine | Recruiting | Chicago | Illinois | 60637 | United States |
IPD will not be shared with other researchers
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| Standard of care ice therapy | Other | Use of commercial reusable ice packs as often as possible, but a minimum of three 15 minute uses per day, for the first 3 days after surgery. No single use should last longer than 30 minutes. |
|
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |