Using VibraCool to reduce pain and opioid use after ACL surgery
Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
This study is testing if the VibraCool device can help reduce pain and the need for opioids after ACL surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 130 (estimated) |
| Sex | All |
| Sponsor | Columbia University Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06456268 on ClinicalTrials.gov |
What this trial studies
This project aims to evaluate the effectiveness of the VibraCool device, which provides mechanical stimulation, in reducing postoperative pain and opioid consumption following anterior cruciate ligament reconstruction (ACLR). Participants will receive treatment with VibraCool, alongside traditional cryocompression and standard ice packs, to assess the impact on pain management and opioid reliance. The study will focus on patients who have undergone ACL reconstruction to determine the device's efficacy in this specific surgical context.
Who should consider this trial
Good fit: Ideal candidates for this study are adults who have recently undergone ACL reconstruction.
Not a fit: Patients who are pediatric or have undergone iliotibial band ACL reconstruction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and decrease the need for opioids in patients recovering from ACL surgery.
How similar studies have performed: Other studies have explored similar neuromodulatory approaches, but the specific application of VibraCool in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Underwent ACL reconstruction Exclusion Criteria: * Pediatric iliotibial band ACL reconstruction (known to cause significantly more pain) * Non-english speakers (limitations of our study group)
Where this trial is running
New York, New York
- Columbia University Medical Center — New York, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.