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

Not Applicable

Recruiting

• Conditions: Carpal Tunnel Syndrome; Perioperative/Postoperative Complications
• Interventions: Other: Polarcare Machine; Other: Standard of care ice therapy

• Registration Number: NCT05783245
• Lead Sponsor: University of Chicago

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.

Study Timeline

• Study First Submitted: 2023-03-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-24
• Study Start: 2023-06-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-09-01
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Ice Therapy	Polarcare Machine	Postoperative care with experimental ice therapy
Standard of Care Ice Therapy	Standard of care ice therapy	Postoperative care with standard of care ice therapy

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) for pain	3 days	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.

Secondary Outcome Measures

Name	Time	Method
Disabilities of the Arm, Shoulder, and Hand questionnaire	1 week	he DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs.

Trial Locations

Locations (1)

University of Chicago Medicine; 🇺🇸 Chicago, Illinois, United States