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NCT Number: NCT05783245

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Perioperative/Postoperative Complications Peripheral Nervous System Diseases Postoperative Complications Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location status: Recruiting

Location contact

Jennifer Wolf, MD

CONTACT

[email protected]

Patrick Nelson, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Visual Analog Scale (VAS) for pain

    Time frame: 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 outcomes

  1. Disabilities of the Arm, Shoulder, and Hand questionnaire

    Time frame: 1 week

    he DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs.

Study contacts

Contact information is provided by the study sponsor or research team.

Patrick Nelson, MD

CONTACT

[email protected]

773-834-3531

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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