What is the mechanism of action of this treatment?

Common treatments for osteoarthritis include exercise therapy, pharmacologic interventions, and surgical options. Exercise therapy improves pain and function by enhancing muscle strength, endurance, and joint stability, and by reducing inflammation. Pharmacologic treatments, such as NSAIDs and corticosteroids, target pain and inflammation. Surgical options, like total knee replacement, address severe joint damage. Vibration therapy, including Whole Body Vibration (WBV) and Local Muscle Vibration (LMV), aims to enhance muscle function, improve joint biomechanics, and promote better knee joint health by stimulating muscle contractions and improving neuromuscular control. Understanding these mechanisms helps osteoarthritis patients and their doctors choose the most appropriate treatment to manage symptoms and improve quality of life.

What side effects are associated with this type of intervention?

Vibration therapy, including Whole Body Vibration (WBV) and Local Muscle Vibration (LMV), is generally considered safe but may cause mild side effects such as muscle soreness, fatigue, and dizziness. Other common treatments for osteoarthritis include oral NSAIDs, which can lead to gastrointestinal issues, cardiovascular risks, and kidney problems; and intraarticular glucocorticoid injections, which may cause joint infection, increased pain, and cartilage damage. Exercise therapy, another common treatment, is typically safe but can sometimes result in temporary muscle soreness or injury if not performed correctly.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for osteoarthritis that utilize Whole Body Vibration (WBV) or Local Muscle Vibration (LMV). However, various non-pharmacologic therapies, such as physical therapy and exercise regimens, are commonly recommended to improve muscle function and joint health. These approaches share similar goals with vibration therapy, aiming to enhance muscle strength, improve joint biomechanics, and promote overall knee joint health. While vibration therapy is being studied for its potential benefits, it has not yet received FDA approval for the treatment of osteoarthritis.

What other types of research exist?

Promising alternatives to WBV and LMV for osteoarthritis patients include: <ol> <li>Therapeutic Exercise: This includes systematic physical movements, postures, or activities designed to improve function and reduce pain. Examples are Pilates and core stabilization exercises.</li> <li>Self-Massage: Regular self-massage of the quadriceps muscle has shown benefits in reducing pain and improving physical function.</li> <li>Low-Level Laser Therapy: This therapy uses specific wavelengths of light to reduce pain and improve function, although results have been inconsistent.</li> <li>Alexander Technique: This involves hands-on instruction to improve balance, posture, and coordination, which can help reduce pain and disability.</li> <li>Directional Preference Exercises: These exercises are tailored to the patient's specific pain patterns and can be more effective than general exercises.</li> </ol>

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Vibration Therapy for Osteoarthritis after ACL Injury

N/A

Recruiting

Led By Troy Blackburn, PhD

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post acl reconstruction surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding vibrations to standard recovery exercises can help people who have had ACL surgery. The vibrations aim to improve muscle function and movement, potentially reducing the risk of further knee problems.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated in this summary, potential side effects from participating could include discomfort from vibrations during treatment sessions and possible aggravation of existing conditions due to physical therapy activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post acl reconstruction surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post acl reconstruction surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post acl reconstruction surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery

Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery

Knee Replacement Arthroplasty (procedure)

+5 more

Secondary study objectives

Change in ACL-QOL total score over the first 12 months following ACL reconstruction surgery

Change in IKDC total score over the first 12 months following ACL reconstruction surgery

Change in KOOS total score over the first 12 months following ACL reconstruction surgery

+29 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Whole Body VibrationExperimental Treatment1 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 VibrationExperimental Treatment1 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 RehabilitationActive Control1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for osteoarthritis include exercise therapy, pharmacologic interventions, and surgical options. Exercise therapy improves pain and function by enhancing muscle strength, endurance, and joint stability, and by reducing inflammation. Pharmacologic treatments, such as NSAIDs and corticosteroids, target pain and inflammation. Surgical options, like total knee replacement, address severe joint damage. Vibration therapy, including Whole Body Vibration (WBV) and Local Muscle Vibration (LMV), aims to enhance muscle function, improve joint biomechanics, and promote better knee joint health by stimulating muscle contractions and improving neuromuscular control. Understanding these mechanisms helps osteoarthritis patients and their doctors choose the most appropriate treatment to manage symptoms and improve quality of life.