Pain, Postoperative Clinical Trial
Official title:
Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction
NCT number | NCT06456268 |
Other study ID # | AAAU3696 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 30, 2024 |
Est. completion date | July 15, 2025 |
Verified date | June 2024 |
Source | Columbia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this project is to test the effects of the VibraCool mechanical stimulation neuromodulatory therapeutic device on post-operative pain and opioid use following ACLR, and thus residual opioids in circulation.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | July 15, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Underwent ACL reconstruction Exclusion Criteria: - Pediatric IT band ACL reconstruction (known to cause significantly more pain) - Non-english speakers (limitations of our study group) |
Country | Name | City | State |
---|---|---|---|
United States | Columbia University Medical Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS pain | Scale of 0 to 10, with 10 being the worst pain and 0 being no pain. Will record daily mean VAS pain scores over the first seven post-operative days | First 7 post-operative days | |
Primary | Opioid use | Percent of patients discontinuing opioid use by or on post-operative day three, compared to those who continue after day three | First 3 post-operative days | |
Secondary | Mean reduction in opioid use in mg of morphine equivalents per day | mean reduction in opioid use in milligrams of morphine equivalents per day (MMOD) of 30% from patients not using the device over the 7-day period | First 7 post-operative days | |
Secondary | PROMIS Pain Interference score | PROMIS is a computerized adaptive patient-reported test to measure interference of pain in everyday functioning. The raw score is converted to a T-score metric in which 50 is the mean and 10 is the standard deviation. Higher T-scores represent increased pain interference. | First 7 post-operative days |
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