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

Sponsor

University of Chicago (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05783245

Collaborator

(none)

128

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carpal Tunnel Syndrome Perioperative/Postoperative Complications	Other: Polarcare Machine Other: Standard of care ice therapy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

128 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Medicine	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Jennifer Wolf, MD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT05783245

Other Study ID Numbers:

IRB21-1298

First Posted:

Mar 24, 2023

Last Update Posted:

Mar 24, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carpal Tunnel Syndrome

Pain, Postoperative

Postoperative Complications

Study Results

No Results Posted as of Mar 24, 2023