Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release
Primary Purpose
Carpal Tunnel Syndrome, Perioperative/Postoperative Complications
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Polarcare Machine
Standard of care ice therapy
Sponsored by
About this trial
This is an interventional prevention trial for Carpal Tunnel Syndrome
Eligibility Criteria
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
Sites / Locations
- University of Chicago Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Ice Therapy
Standard of Care Ice Therapy
Arm Description
Postoperative care with experimental ice therapy
Postoperative care with standard of care ice therapy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05783245
Brief Title
Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release
Official Title
Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Perioperative/Postoperative Complications
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Ice Therapy
Arm Type
Experimental
Arm Description
Postoperative care with experimental ice therapy
Arm Title
Standard of Care Ice Therapy
Arm Type
Active Comparator
Arm Description
Postoperative care with standard of care ice therapy
Intervention Type
Other
Intervention Name(s)
Polarcare Machine
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care ice therapy
Intervention Description
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 Outcome Measure Information:
Title
Visual Analog Scale (VAS) for pain
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder, and Hand questionnaire
Description
he DASH is a 30-item self-report questionnaire designed to assess musculoskeletal disorders of the upper limbs.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick Nelson, MD
Phone
773-834-3531
Email
Patrick.Nelson@uchospitals.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Wolf, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Nelson, MD
Email
Patrick.Nelson@uchospitals.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Wolf, MD
Email
jwolf@bsd.uchicago.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared with other researchers
Learn more about this trial
Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release
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