Recruiting

Cooling Therapy

Sponsor:

University of Chicago

Code:

NCT05783245

Conditions

Carpal Tunnel Syndrome

Perioperative/Postoperative Complications

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Polarcare Machine

Standard of care ice therapy

Study Details

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.

Conditions

Carpal Tunnel Syndrome

Perioperative/Postoperative Complications

Study ID

NCT05783245

Start date

Jun 1, 2023

Status verified date

Feb, 2026

Completion date

Sep 30, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental Ice Therapy

Postoperative care with experimental ice therapy

active comparator: Standard of Care Ice Therapy

Postoperative care with standard of care ice therapy

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.

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.

Primary outcome measure

  • Visual Analog Scale (VAS) for pain [ Time Frame: 3 days ]

Central Contacts and Locations

Central contacts

Patrick Nelson, MD

773-834-3531Patrick.Nelson@uchospitals.edu

Locations

University of Chicago Medicine

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Patrick Nelson, MD

Patrick.Nelson@uchospitals.edu

Jennifer Wolf, MD

jwolf@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-05.