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

NCT05783245 | Recruiting

• 1 other identifier: IRB21-1298
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disabilities of the Arm, Shoulder, and Hand questionnaire

  1 week

Study Arms (2)

Experimental Ice Therapy

EXPERIMENTAL

Postoperative care with experimental ice therapy

Other: Polarcare Machine

Standard of Care Ice Therapy

ACTIVE COMPARATOR

Postoperative care with standard of care ice therapy

Other: Standard of care ice therapy

Interventions

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.

Experimental Ice Therapy

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.

Standard of Care Ice Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Indicated for open carpal tunnel release
• Able and willing to complete online questionnaires

You may not qualify if:

• Prior carpal tunnel surgery for ipsilateral extremity
• Additional procedures to be performed on ipsilateral or contralateral extremity
• Current opioid or narcotic pain medication usage

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Postoperative Complications

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jennifer Wolf, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Nelson, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: March 24, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)