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

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.

Study Overview

• Status: Recruiting
• Conditions: Carpal Tunnel Syndrome; Perioperative/Postoperative Complications
• Intervention / Treatment: Other: Polarcare Machine; Other: Standard of care ice therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patrick Nelson, MD; Phone Number: 773-834-3531; Email: Patrick.Nelson@uchospitals.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Recruiting
      • University of Chicago Medicine
      • Contact: Jennifer Wolf, MD; Email: jwolf@bsd.uchicago.edu
      • Contact: Patrick Nelson, MD; Email: Patrick.Nelson@uchospitals.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Ice Therapy; Postoperative care with experimental ice therapy	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.
Active Comparator: Standard of Care Ice Therapy; Postoperative care with standard of care ice therapy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: Jennifer Wolf, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Pathological Conditions, Signs and Symptoms; Carpal Tunnel Syndrome; Postoperative Complications
• Other Study ID Numbers: IRB21-1298

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No