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

NCT ID: NCT05783245

Last Updated: 2026-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2026-09-30

Brief 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.

Detailed 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.

Conditions

Carpal Tunnel Syndrome; Perioperative/Postoperative Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Ice Therapy

Postoperative care with experimental ice therapy

Group Type: EXPERIMENTAL

Polarcare Machine

Intervention Type: 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.

Standard of Care Ice Therapy

Postoperative care with standard of care ice therapy

Group Type: ACTIVE_COMPARATOR

Standard of care ice therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Wolf, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

University of Chicago Medicine

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Patrick Nelson, MD

Role: CONTACT

Patrick.Nelson@uchospitals.edu

773-834-3531

Facility Contacts

Patrick Nelson, MD

Role: primary

Patrick.Nelson@uchospitals.edu

Jennifer Wolf, MD

Role: backup

jwolf@bsd.uchicago.edu

Other Identifiers

IRB21-1298

Identifier Type: -

Identifier Source: org_study_id