Effects of Vibration on Knee Health After ACL Surgery
The Effects of Vibratory Stimuli on Joint Health and Post-traumatic Osteoarthritis Risk Following Anterior Cruciate Ligament Injury
This study is testing if adding vibration therapy to regular rehab can help people recovering from ACL surgery have better knee health and lower the chance of future injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | University of North Carolina, Chapel Hill Academic / other |
| Locations | 2 sites (Chapel Hill, North Carolina and 1 other locations) |
| Trial ID | NCT04875052 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of vibration therapy on post-traumatic knee osteoarthritis risk and secondary ACL injury in individuals recovering from ACL reconstruction surgery. Participants will be randomly assigned to receive standard rehabilitation, standard rehabilitation with whole body vibration (WBV), or local muscle vibration (LMV). The study aims to assess various outcomes including quadriceps muscle function, gait biomechanics, patient-reported outcomes, and MRI indicators of knee joint health. The hypothesis is that vibration therapy will enhance recovery and reduce the risk of complications compared to standard rehabilitation alone.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 to 35 who have undergone unilateral primary ACL reconstruction with a specific type of graft.
Not a fit: Patients with a history of prior ACL injuries, knee surgeries, or certain contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols that reduce the risk of knee osteoarthritis and secondary injuries in ACL reconstruction patients.
How similar studies have performed: While the use of vibration therapy in rehabilitation is promising, this specific approach to addressing post-traumatic knee osteoarthritis and ACL injury risk is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 16 to 35 years * Unilateral, primary ACLR with bone-patellar tendon-bone autograft Exclusion Criteria: * History of prior ACL injury or revision ACLR * History of prior knee surgery * Requirement of multiple ligament surgery at time of ACLR * Concomitant injuries or surgical procedures at the time of ACLR that would delay early post-operative weight bearing based on surgeon recommendations (e.g. lower extremity fracture, intra-articular fracture, microfracture procedure) * Removal of more than 1/3 of the medial or lateral meniscus at the time of ACLR * Articular cartilage damage greater than 3A on the International Cartilage Repair Society Criteria at the time of ACLR * History of musculoskeletal injury to either leg in the 3 months prior to participation other than primary ACL injury * Prior diagnosis of radiographic OA in any joint of the lower extremity * History of neurological disorder (e.g. stroke, multiple sclerosis, etc.) * Contraindications for MRI (e.g. extreme claustrophobia, cardiac pacemaker, cochlear implant, metal foreign bodies, aneurism clip, etc.) * Pregnant or planning to become pregnant
Where this trial is running
Chapel Hill, North Carolina and 1 other locations
- MOTION Science Institute — Chapel Hill, North Carolina, United States (Recruiting)
- Womack Army Medical Center — Chapel Hill, North Carolina, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Troy Blackburn, PhD — University of North Carolina, Chapel Hill
- Study coordinator: Troy Blackburn, PhD
- Email: troyb@email.unc.edu
- Phone: 919-843-2021
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.