Knee OsteoarthritisNCT02605876
Vibratory Stimuli, A Novel Rehabilitation Method for Preventing Post - Traumatic Knee Osteoarthritis
A study testing Whole body vibration and Local muscle vibration in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This study will evaluate the acute effects of vibration (whole body vibration and local muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics linked to osteoarthritis development in individuals with anterior cruciate ligament reconstruction. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Whole body vibration and Local muscle vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2015to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-35 years
- undergone unilateral ACLR within 5 years prior to participation
- at least 6 months post-ACLR
- Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report survey Pain subscale score > 53.1 and Symptom subscale score > 44.9
- cleared by a physician for return to physical activity, and currently participating in at least 20 minutes of physical activity 3x per week.
Who cannot join
- central activation ratio (CAR) > 95%
- history of ACL graft rupture or revision surgery, neurological disorder, or injury to either leg within 6 months prior to participation (other than the initial ACLR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Neuromuscular Research Lab, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Vibratory Stimuli: A Novel Rehabilitation Method for Preventing Post-traumatic Knee Osteoarthritis
This study will evaluate the acute effects of vibration (whole body vibration and local muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics linked to osteoarthritis development in individuals with anterior cruciate ligament reconstruction. Subjects will be randomly assigned to control (no vibration), whole body vibration, and local muscle vibration groups, and the aforementioned characteristics will be assessed prior to and following the respective interventions.
Read the detailed description
Quadriceps muscle dysfunction and proprioceptive deficits following knee injuries alter walking gait biomechanics in manners that contribute to development of knee osteoarthritis. Current rehabilitation techniques are minimally effective for addressing these complications and preventing knee osteoarthritis. Anterior cruciate ligament reconstruction dramatically increases the risk of knee osteoarthritis, and represents an ideal model for evaluating novel rehabilitation techniques for preventing knee osteoarthritis.
Direct (local muscle vibration) and indirect (whole body vibration) vibratory stimuli enhance quadriceps function and proprioception, and may improve rehabilitation and reduce the risk of knee osteoarthritis. The purpose of this investigation is to determine and compare the acute effects of whole body vibration and local muscle vibration on quadriceps function, knee proprioception, and gait biomechanics in individuals with anterior cruciate ligament reconstruction. The investigators hypothesize that vibratory stimuli will enhance quadriceps function, knee proprioception, and gait biomechanics in manners that would reduce the risk of developing knee osteoarthritis, and that whole body vibration and local muscle vibration will produce equivalent improvements in these characteristics.
- Conditions
- Knee Osteoarthritis
- Being tested
- Whole body vibration, Local muscle vibration
- Keywords
- anterior cruciate ligament reconstruction
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body vibrationDevice
Local muscle vibrationDevice
| Study group | Role | What they receive |
|---|---|---|
| Whole Body Vibration | Experimental | Subjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures. Receives: Device: Whole body vibration |
| Local Muscle Vibration | Experimental | Subjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures. Receives: Device: Local muscle vibration |
| Control | No intervention | Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear Ground Reaction Force Loading Rate
Change score (Post-Pre) for the ground reaction force during the first 50% of the stance phase calculated as the slope of the vertical ground reaction force time series curve from heelstrike to the first ground reaction force peak. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 8.5-9.5 multiples of body weight per second.
Measured: Prior to and immediately following vibration interventions (within 5 minutes).
Quadriceps Strength
Change score (Post-Pre) for maximal isometric knee extension peak torque in Newton*meters/kilogram body mass. Though a "normal" value has not been established, typical values for the raw values (i.e. not changes scores) range 1.5-3.5 Newton*meters/kilogram body mass.
Measured: Prior to and immediately following vibration interventions (within 10 minutes)
Knee Proprioception
Change score (Post-Pre) for the absolute sagittal plane joint reposition error. This value, measured in degrees, represents the absolute difference between a target knee flexion angle and the angle the subject reproduces, and assesses how well the subject can perceive the position of his/her knee in space. Typical values for the raw scores (i.e. not change scores) range from 0.5 - 5 degrees.
Measured: Prior to and immediately following vibration interventions (within 5 minutes)
Instantaneous Ground Reaction Force Loading Rate
Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 50-70 multiples of body weight per second.
Measured: Immediately prior to and following the interventions (within 5 minutes)
Secondary outcomes (2)
Peak Internal Knee Extension Moment
Change score (Post-Pre) for the peak internal knee extension moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the sagittal plane of motion, and is indicative of quadriceps muscle function during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.
Measured: Immediately prior to and following the interventions (within 5 minutes)
Peak Internal Knee Valgus Moment
Change score (Post-Pre) for the peak internal knee valgus moment during the first 50% of the stance phase. This value reflects the internal (i.e. muscle and other soft tissue) response to external loading of the knee joint in the frontal plane of motion, and is indicative of medial tibiofemoral joint loading during walking. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 2-4 % body weight x height.
Measured: Immediately prior to and following the interventions (within 5 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study start1 Oct 2015
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Troy Blackburn, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605876
- Sponsor's protocol ID
- 15-0838
- Status last verified
- Oct 2019
- First submitted
- 6 Nov 2015
- Last updated
- 19 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dennis JD, Edison AE, Birchmeier TB, Pietrosimone BG, Blackburn JT. Whole Body Vibration Acutely Decreases Medial Tibiofemoral Contact Force During Walking Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2026 Mar;44(3):e70166. doi: 10.1002/jor.70166.
PubMed 41761462Blackburn T, Padua DA, Pietrosimone B, Schwartz TA, Spang JT, Goodwin JS, Dewig DR, Johnston CD. Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. J Orthop Res. 2021 May;39(5):1113-1122. doi: 10.1002/jor.24821. Epub 2020 Aug 12.
PubMed 32757272Blackburn JT, Pietrosimone B, Spang JT, Goodwin JS, Johnston CD. Somatosensory Function Influences Aberrant Gait Biomechanics Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2020 Mar;38(3):620-628. doi: 10.1002/jor.24495. Epub 2019 Oct 24.
PubMed 31608488Blackburn T, Pietrosimone B, Goodwin JS, Johnston C, Spang JT. Co-activation during gait following anterior cruciate ligament reconstruction. Clin Biomech (Bristol). 2019 Jul;67:153-159. doi: 10.1016/j.clinbiomech.2019.05.010. Epub 2019 May 9.
PubMed 31121428
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibratory Stimuli: A Novel Rehabilitation Method for Preventing Post-traumatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02605876
- Acronym / sponsor ID
- 15-0838
- Conditions
- Knee Osteoarthritis
- Keywords
- anterior cruciate ligament reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 16 Nov 2015 (estimated)
- Results
- Posted 19 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the acute effects of vibration (whole body vibration and local muscle vibration) on quadriceps function, knee joint proprioception, and gait biomechanics linked to osteoarthritis development in individuals with anterior cruciate ligament reconstruction. Subjects will be randomly assigned to control (no vibration), whole body vibration, and local muscle vibration groups, and the aforementioned characteristics will be assessed prior to and following the respective interventions.
Detailed description
Quadriceps muscle dysfunction and proprioceptive deficits following knee injuries alter walking gait biomechanics in manners that contribute to development of knee osteoarthritis. Current rehabilitation techniques are minimally effective for addressing these complications and preventing knee osteoarthritis. Anterior cruciate ligament reconstruction dramatically increases the risk of knee osteoarthritis, and represents an ideal model for evaluating novel rehabilitation techniques for preventing knee osteoarthritis.
Direct (local muscle vibration) and indirect (whole body vibration) vibratory stimuli enhance quadriceps function and proprioception, and may improve rehabilitation and reduce the risk of knee osteoarthritis. The purpose of this investigation is to determine and compare the acute effects of whole body vibration and local muscle vibration on quadriceps function, knee proprioception, and gait biomechanics in individuals with anterior cruciate ligament reconstruction. The investigators hypothesize that vibratory stimuli will enhance quadriceps function, knee proprioception, and gait biomechanics in manners that would reduce the risk of developing knee osteoarthritis, and that whole body vibration and local muscle vibration will produce equivalent improvements in these characteristics.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whole Body Vibration | Experimental | Device: Whole body vibrationSubjects will receive whole body vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures. |
| Local Muscle Vibration | Experimental | Device: Local muscle vibrationSubjects will receive local muscle vibration (30Hz, 2g) applied continuously for 1 minute. This exposure will be repeated 6 times with 2 minutes of rest between exposures. |
| Control | No intervention | –Subjects will perform the same procedures as the experimental groups with the exception that no vibratory stimulus will be applied. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- age 18-35 years
- undergone unilateral ACLR within 5 years prior to participation
- at least 6 months post-ACLR
- Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report survey Pain subscale score > 53.1 and Symptom subscale score > 44.9
- cleared by a physician for return to physical activity, and currently participating in at least 20 minutes of physical activity 3x per week.
Key exclusion criteria (2 listed)
- central activation ratio (CAR) > 95%
- history of ACL graft rupture or revision surgery, neurological disorder, or injury to either leg within 6 months prior to participation (other than the initial ACLR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body vibration | Device | Whole Body Vibration |
| Local muscle vibration | Device | Local Muscle Vibration |
Primary outcome
Linear Ground Reaction Force Loading Rate
Time frame: Prior to and immediately following vibration interventions (within 5 minutes).
Change score (Post-Pre) for the ground reaction force during the first 50% of the stance phase calculated as the slope of the vertical ground reaction force time series curve from heelstrike to the first ground reaction force peak. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 8.5-9.5 multiples of body weight per second.
Quadriceps Strength
Time frame: Prior to and immediately following vibration interventions (within 10 minutes)
Change score (Post-Pre) for maximal isometric knee extension peak torque in Newton*meters/kilogram body mass. Though a "normal" value has not been established, typical values for the raw values (i.e. not changes scores) range 1.5-3.5 Newton*meters/kilogram body mass.
Knee Proprioception
Time frame: Prior to and immediately following vibration interventions (within 5 minutes)
Change score (Post-Pre) for the absolute sagittal plane joint reposition error. This value, measured in degrees, represents the absolute difference between a target knee flexion angle and the angle the subject reproduces, and assesses how well the subject can perceive the position of his/her knee in space. Typical values for the raw scores (i.e. not change scores) range from 0.5 - 5 degrees.
Instantaneous Ground Reaction Force Loading Rate
Time frame: Immediately prior to and following the interventions (within 5 minutes)
Change score (Post-Pre) loading rate calculated as the peak of the first time derivative of the vertical ground reaction force time series curve during the first 50% of the stance phase. Though a "normal" value has not been established, typical values for the raw scores (i.e. not change scores) range 50-70 multiples of body weight per second.
2 secondary outcomes
Peak Internal Knee Extension Moment
Time frame: Immediately prior to and following the interventions (within 5 minutes)
Peak Internal Knee Valgus Moment
Time frame: Immediately prior to and following the interventions (within 5 minutes)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41761462Dennis JD, Edison AE, Birchmeier TB, Pietrosimone BG, Blackburn JT. Whole Body Vibration Acutely Decreases Medial Tibiofemoral Contact Force During Walking Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2026 Mar;44(3):e70166. doi: 10.1002/jor.70166.
- Derived from this study: PubMed 32757272Blackburn T, Padua DA, Pietrosimone B, Schwartz TA, Spang JT, Goodwin JS, Dewig DR, Johnston CD. Vibration improves gait biomechanics linked to posttraumatic knee osteoarthritis following anterior cruciate ligament injury. J Orthop Res. 2021 May;39(5):1113-1122. doi: 10.1002/jor.24821. Epub 2020 Aug 12.
- Derived from this study: PubMed 31608488Blackburn JT, Pietrosimone B, Spang JT, Goodwin JS, Johnston CD. Somatosensory Function Influences Aberrant Gait Biomechanics Following Anterior Cruciate Ligament Reconstruction. J Orthop Res. 2020 Mar;38(3):620-628. doi: 10.1002/jor.24495. Epub 2019 Oct 24.
- Derived from this study: PubMed 31121428Blackburn T, Pietrosimone B, Goodwin JS, Johnston C, Spang JT. Co-activation during gait following anterior cruciate ligament reconstruction. Clin Biomech (Bristol). 2019 Jul;67:153-159. doi: 10.1016/j.clinbiomech.2019.05.010. Epub 2019 May 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Troy Blackburn, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole body vibration and Local muscle vibration in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear Ground Reaction Force Loading Rate (time frame: Prior to and immediately following vibration interventions (within 5 minutes).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02605876, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2019.