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NCT06456268 | RECRUITING | ACL


VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
Sponsor:

Columbia University

Information provided by (Responsible Party):

Lauren H. Redler

Brief Summary:

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 anterior crucitate ligament reconstruction (ACLR), and thus residual opioids in circulation.

Condition or disease

ACL

Opioid Use

Cryotherapy Effect

Vibration; Exposure

Pain, Postoperative

Intervention/treatment

VibraCool mechanical stimulation and neuromodulatory therapeutic device

Cryocompression (Game Ready, Bregs) device

Standard ice packs

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 130 participants
Masking : SINGLE
Masking Description : Blinded data will be provided to the statistician w/o reference to specific treatment arms
Primary Purpose : TREATMENT
Official Title : Clinical Evaluation of an External Neuromodulation Device (VibraCool) to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)
Actual Study Start Date : 2025-09-30
Estimated Primary Completion Date : 2026-11-30
Estimated Study Completion Date : 2026-11-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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)

VibraCool Device to Reduce Pain and Opioid Use After Anterior Cruciate Ligament Reconstruction (ACLR)

Location Details

NCT06456268


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Locations


RECRUITING

United States, New York

Columbia University Medical Center

New York, New York, United States, 10032

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