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Cooling Therapy for Post-Operative Pain in Carpal Tunnel Syndrome
N/A
Recruiting
Led By Jennifer Wolf, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 or older
Indicated for open carpal tunnel release
Must not have
Current opioid or narcotic pain medication usage
Additional procedures to be performed on ipsilateral or contralateral extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
No Placebo-Only Group
Summary
This trial will compare two methods of treating post-op pain after open surgery: cooling therapy vs. traditional ice.
Who is the study for?
This trial is for adults over 18 who need open carpal tunnel release surgery and can fill out online questionnaires. It's not for those who've had previous carpal tunnel surgery on the same hand or will have other procedures on either hand, or are currently using opioid pain meds.
What is being tested?
The study compares two ways to manage pain after carpal tunnel surgery: a Polarcare Machine that provides continuous cooling therapy versus standard ice packs. The goal is to see which method better reduces post-operative pain.
What are the potential side effects?
Potential side effects may include skin irritation from cold exposure, discomfort due to the cold therapy, and possible numbness in the treated area. These are common reactions when applying cold treatments.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am recommended to have surgery for carpal tunnel syndrome.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently taking opioid or narcotic pain medication.
Select...
I am scheduled for procedures on the same or opposite limb.
Select...
I have had carpal tunnel surgery on the same side as my current condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Analog Scale (VAS) for pain
Secondary study objectives
Disabilities of the Arm, Shoulder, and Hand questionnaire
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental Ice TherapyExperimental Treatment1 Intervention
Postoperative care with experimental ice therapy
Group II: Standard of Care Ice TherapyActive Control1 Intervention
Postoperative care with standard of care ice therapy
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,062 Previous Clinical Trials
840,006 Total Patients Enrolled
Jennifer Wolf, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
90 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking opioid or narcotic pain medication.I am scheduled for procedures on the same or opposite limb.I am 18 years old or older.I can and will complete online questionnaires.I have had carpal tunnel surgery on the same side as my current condition.I am recommended to have surgery for carpal tunnel syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Ice Therapy
- Group 2: Experimental Ice Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.