Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05783245
• Other study ID #: IRB21-1298
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: May 2023
• Source: University of Chicago
• Contact: Patrick Nelson, MD
• Phone: 773-834-3531
• Email: Patrick.Nelson[@]uchospitals.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: September 30, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. Indicated for open carpal tunnel release

3. Able and willing to complete online questionnaires

Exclusion Criteria:

1. Prior carpal tunnel surgery for ipsilateral extremity

2. Additional procedures to be performed on ipsilateral or contralateral extremity

3. Current opioid or narcotic pain medication usage

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Pain, Postoperative
• Perioperative/Postoperative Complications
• Postoperative Complications

Intervention

Other:
• Polarcare Machine
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.
• Standard of care ice therapy
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.

Locations

Country	Name	City	State
United States	University of Chicago Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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