Vibration Therapy for Osteoarthritis after ACL Injury

Recruiting at 1 trial location

Overseen By Troy Blackburn, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Prior ACL injury, Knee surgery, Neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding vibration therapy to standard knee rehabilitation improves recovery for those who have undergone ACL reconstruction surgery. Researchers aim to determine if vibration enhances muscle strength, knee movement, and overall joint health compared to standard rehab alone. Participants will be divided into three groups: standard rehab alone, standard rehab with whole body vibration, or standard rehab with local muscle vibration. The trial suits individuals aged 16 to 35 who have had a single ACL surgery using a bone-patellar tendon-bone graft and have no significant past knee issues. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future rehabilitation methods.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

What prior data suggests that vibration therapy is safe for individuals with ACL injuries?

Research has shown that local muscle vibration (LMV) is generally safe and may aid recovery from ACL surgery. One study found that LMV with a vibration frequency over 100 Hz can assist rehabilitation without safety issues. Another study discovered that applying LMV to relaxed muscles can accelerate recovery.

For whole-body vibration (WBV), research indicates it can improve knee function, balance, and muscle strength. One study suggested it is safe for individuals with knee osteoarthritis, though some research advises caution and consideration of individual health conditions.

Both LMV and WBV have demonstrated positive results with no major safety concerns, making them promising options for recovery after ACL surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about vibration therapy for osteoarthritis after ACL injury because it offers a unique approach to enhancing rehabilitation. Unlike standard rehabilitation, which focuses solely on exercises to restore movement and strength, vibration therapy introduces either local muscle or whole body vibration at the start of each session. This new technique aims to boost the effectiveness of traditional exercises by potentially improving muscle activation and neuromuscular control more quickly. By integrating these vibrations, the therapy could lead to faster recovery and better outcomes for patients, making it a promising addition to existing treatment options.

What evidence suggests that this trial's treatments could be effective for osteoarthritis after ACL injury?

Research has shown that vibration therapy can aid recovery from ACL surgery. In this trial, participants will join different treatment arms to assess the effects of vibration therapy. Local Muscle Vibration (LMV), one of the experimental treatments, may enhance muscle strength and reduce pain, which is crucial for healing. Studies suggest that using a frequency above 100 Hz is particularly beneficial for patients who have undergone ACL reconstruction. Another experimental treatment, Whole Body Vibration (WBV), has been linked to improved knee function and stronger muscles. It can also enhance balance and muscle activity, potentially boosting overall knee health. Both types of vibration therapy offer potential benefits for recovery after ACL surgery. ^{1 2 3 5 6}

Who Is on the Research Team?

Troy Blackburn, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for individuals aged 16-35 who've had a specific knee surgery (ACLR) using their own tissue. They must not have had previous ACL injuries, other knee surgeries, recent leg injuries besides the primary ACL injury, diagnosed arthritis in lower joints, neurological disorders, MRI contraindications like metal implants or severe claustrophobia, or be pregnant.

Inclusion Criteria

You are between 16 and 35 years old.

You had surgery to fix your ACL using a specific type of tendon from your own body.

Exclusion Criteria

You have previously injured your ACL or had surgery to repair it.

You have had surgery on your knee in the past.

You need to have surgery on more than one ligament at the same time as your ACL surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Rehabilitation

Participants undergo standard rehabilitation with or without vibration therapy

20 weeks

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Assessments at 1, 6, and 12 months post-ACLR

What Are the Treatments Tested in This Trial?

Interventions

• Local Muscle Vibration
• Standard ACL Rehabilitation
• Whole Body Vibration

Trial Overview The study tests if adding vibration to standard rehab after ACL surgery can improve outcomes. Participants are randomly placed into three groups: one with regular rehab exercises; another adds whole body vibration; and the last uses local muscle vibration. Their muscle function, gait, joint health via MRI and risk of re-injury will be monitored over a year.

How Is the Trial Designed?

Group I: Whole Body Vibration Experimental Treatment 1 Intervention

Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to whole body vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.

Group II: Local Muscle Vibration Experimental Treatment 1 Intervention

Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to local muscle vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.

Group III: Standard ACL Rehabilitation Active Control 1 Intervention

Patients will complete a 20-week supervised, progressive rehabilitation protocol directed by physical therapists at 1 of 3 participating clinics. While the specific rehabilitation exercises and techniques used for a given patient may vary depending on clinician preference/experience and patient responsiveness and progress, the general rehabilitation protocol will be standardized and follow current best practices emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control consistent with the Multicenter Orthopaedics Outcomes Network (MOON) rehabilitation protocol.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Womack Army Medical Center

Collaborator

Trials

22

Recruited

17,100+

Published Research Related to This Trial

Whole-body vibration (WBV) is gaining attention as a potential therapy to enhance neuromuscular performance and increase bone mass or density.

The International Society of Musculoskeletal and Neuronal Interactions (ISMNI) has provided expert recommendations to improve the quality and consistency of reports on WBV treatment studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting whole-body vibration intervention studies: recommendations of the International Society of Musculoskeletal and Neuronal Interactions. Rauch, F., Sievanen, H., Boonen, S., et al.[2022]

In a study of 75 individuals who underwent anterior cruciate ligament reconstruction (ACLR), local muscle vibration (LMV) significantly reduced the peak vertical ground reaction force loading rate, which is important for knee joint health.

Whole-body vibration (WBV) increased the peak internal knee extension moment, suggesting that both vibration techniques may help improve gait biomechanics and potentially lower the risk of posttraumatic knee osteoarthritis (PTOA) after ACLR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. Blackburn, T., Padua, DA., Pietrosimone, B., et al.[2021]

Whole-body vibration therapy, when added to standard rehabilitation after ACL reconstruction, significantly improves medial-lateral and overall postural stability, based on a meta-analysis of 7 studies with 244 participants.

However, this therapy does not show significant benefits for lower limb strength or anterior-posterior stability, indicating that while it may help with balance, it may not enhance muscle strength post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Addition of Whole-Body Vibration Training Improve Postural Stability and Lower Limb Strength During Rehabilitation Following Anterior Cruciate Ligament Reconstruction: A Systematic Review With Meta-analysis. Rowe, PL., Taflan, S., Hahne, AJ.[2023]

A 6-week whole body vibration (WBV) training program was tested on 44 healthy participants to see if it could improve the reflex response of key ankle stabilizing muscles, but no significant changes were observed after the training.

The study concluded that WBV training does not enhance the reflex mechanisms of the peroneus longus, peroneus brevis, or anterior tibialis muscles, indicating that this method may not be effective for improving ankle stability in athletes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of 6-week whole body vibration training on the reflex response of the ankle muscles: a randomized controlled trial. Martínez, F., Rubio, JA., Ramos, DJ., et al.[2021]

Whole-body vibration (WBV) significantly enhances muscle activity in individuals with anterior cruciate ligament (ACL) injuries, particularly at frequencies of 25 to 40 Hz, as shown by increased neuromuscular activation in the injured limb compared to the uninjured limb and healthy controls.

The study suggests that WBV may improve muscle strength in ACL-deficient patients by altering neural pathways, providing specific frequency recommendations for rehabilitation protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of whole body vibration frequency on neuromuscular activity in ACL-deficient and healthy males. Giombini, A., Menotti, F., Laudani, L., et al.[2018]

High frequency whole body vibration (WBV) at 25 Hz significantly improved limits of stability (LOS) in individuals with subacute lateral ankle sprains, showing decreased reaction time and increased movement velocity and maximal excursion after just one session.

The study involved 15 participants aged 19-27 and demonstrated that high frequency WBV could be a quick and effective intervention for enhancing postural stability in physical therapy settings, particularly within one to eight weeks post-injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Whole Body Vibration on the Limits of Stability in Adults With Subacute Ankle Injury. Young, S., Wallmann, HW., Quiambao, KL., et al.[2023]

The study involved 24 participants who underwent ACL reconstruction, with those receiving local body vibration (LBV) showing significant improvements in pain, symptoms, range of motion, and muscle strength compared to the non-LBV group.

LBV therapy not only reduced pain and anxiety but also enhanced physiological measures like isokinetic peak torque and range of motion, indicating its effectiveness as a therapeutic intervention post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation Program Combined with Local Vibroacoustics Improves Psychophysiological Conditions in Patients with ACL Reconstruction. Park, JM., Park, S., Jee, YS.[2020]

Vibration therapy (VT), particularly local muscle vibration (LMV) at frequencies above 100 Hz, significantly improves hamstring peak torque in ACL-reconstructed patients, suggesting it can enhance muscle strength during rehabilitation.

While VT shows some benefits for muscle strength, it does not significantly improve postural control, especially in closed-eye conditions, compared to conventional rehabilitation methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of vibration therapy for muscle peak torque and postural control in individuals with anterior cruciate ligament reconstruction: a systematic review and meta-analysis of clinical trials. Maghbouli, N., Khodadost, M., Pourhassan, S.[2021]

Whole-body vibration (WBV) training has shown potential benefits in improving bone density in the hip and tibia, but not in the lumbar spine, indicating its specific effects on certain areas of the body.

While some studies suggest that WBV can enhance muscle performance, balance, and functional mobility in older adults, the overall quality of the research is variable, and more rigorous studies are needed to establish safe and effective training parameters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of whole-body vibration training in aging adults: a systematic review. Merriman, H., Jackson, K.[2019]

Early whole-body vibration therapy (WBVT) starting one month after anterior cruciate ligament reconstruction (ACLR) significantly improved postural control and muscle performance in patients, as shown in a study of 48 participants over 6 months.

The study found that while WBVT enhanced certain functional abilities like single-legged hop and shuttle run, it did not affect knee joint position sense or other specific performance measures, indicating targeted benefits of this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of early whole-body vibration therapy on neuromuscular control after anterior cruciate ligament reconstruction: a randomized controlled trial. Fu, CL., Yung, SH., Law, KY., et al.[2022]

Whole-body vibration (WBV) significantly improved the early rate of torque development (RTD) in individuals who had undergone anterior cruciate ligament reconstruction (ACLR), with an increase of +5.59 N·m·s·kg after treatment.

In contrast, local muscle vibration (LMV) and no vibration (control) did not show any significant effects on early or late RTD, suggesting that WBV may be a beneficial intervention for enhancing knee function post-ACLR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Body Vibration Improves Early Rate of Torque Development in Individuals With Anterior Cruciate Ligament Reconstruction. Pamukoff, DN., Pietrosimone, B., Ryan, ED., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8280257/

The effectiveness of vibration therapy for muscle peak torque ... This study suggests that VT, especially LMV type with vibration frequency higher than 100 Hz, can be effective in rehabilitation of ACL-reconstructed patients.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32757272/

Vibration improves gait biomechanics linked to ... Vibration improves quadriceps function following ACLR, but its effects on gait biomechanics are unknown. The purpose of this study was to ...

3. trials.arthritis.org trials.arthritis.org/trials/NCT04875052

Vibration and Post-traumatic Osteoarthritis Risk Following ... This study will evaluate the effects of a novel rehabilitation approach on factors related to the risks of PTOA and secondary ACL injury following ACLR.

4. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2021-54063

Vibration Therapy for Osteoarthritis after ACL Injury Additionally, a study on Local Body Vibration (LBV) found that it reduced pain and improved leg strength and movement range. These findings suggest that ...

5. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-023-06334-9

Effect of low-magnitude, variable-frequency vibration therapy ... Our data demonstrated that the use of vibrations of variable frequency and low amplitude in patients with the knee OA is a safe and effective therapy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S187706572030172X

Local vibration training improves the recovery of ... This feasibility study suggests that LVT applied to relaxed muscles is a promising modality of vibration therapy that could be implemented early in ACLR.