Effect of Cooling Therapy for Post-Operative Pain in Open Carpal Tunnel Release
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 or older
Indicated for open carpal tunnel release
Able and willing to complete online questionnaires
Disqualifiers
Prior carpal tunnel surgery for ipsilateral extremity
Additional procedures to be performed on ipsilateral or contralateral extremity
Current opioid or narcotic pain medication usage
Trial design
Design model
Parallel
Treatments tested in this trial
Polarcare Machine
Other interventionUse 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 interventionUse 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.
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Experimental Ice TherapyExperimental treatment 1 intervention
Group B: Standard of Care Ice TherapyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
3 daysSecondary outcomes
1
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.
Time frame
1 weekSponsors and contacts
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Source ClinicalTrials.gov