Osteoarthritis, KneeNCT02881775
Immediate Effects of rTMS on Excitability of the Quadriceps With Knee Osteoarthritis
A study testing rTMS and exercise in people with Osteoarthritis, Knee, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of the study is to identify things that influence the ability to "turn on" the thigh muscle (quadriceps). The thigh muscle tends to be under active with knee osteoarthritis, which may make it difficult to strengthen the muscle. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- rTMS and exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 26 Jun 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- symptomatic knee osteoarthritis primarily involving one leg based on Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 10 (out of 100 points, indicating most dysfunction)
- diagnosis of knee osteoarthritis
- opposite knee with WOMAC pain score ≤ 5.
- opposite knee does not have a diagnosis of knee osteoarthritis
Who cannot join
- conditions affecting the leg other than osteoarthritis
- low blood pressure (< 90 systolic, 60 diastolic) or heart rate (< 60 beats per minute)
- conditions that limit exercise tolerance such as a heart condition
- pregnant or planning to become pregnant in the next 3 months
- conditions that alter sensation and pain processing
- BMI > 35
Show all 15Show fewer
- severe arthritis in both knees
- history of leg or back surgery in the past year or knee replacement surgery;
- injection in the knee joint in the past 4 weeks
- requires an assistive device to walk
- any contraindications for TMS or rTMS (seizures, metal implants in head, brain related conditions, brain injury, drug or alcohol withdrawal)
- medications that lower seizure threshold
- history of fainting spells (syncope) or low blood pressure
- sleep deprived
- inability to understand and repeat back directions regarding the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Immediate Effects of rTMS on Corticospinal Excitability of the Quadriceps in People With Knee Osteoarthritis
The purpose of the study is to identify things that influence the ability to "turn on" the thigh muscle (quadriceps). The thigh muscle tends to be under active with knee osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to determine whether it may help "turn up" activity in the under active thigh muscle immediately after its application. rTMS uses a targeted pulsed magnetic field, similar to what is used in an MRI (magnetic resonance imaging) machine to send an electrical signal from the brain to the thigh muscle.
Read the detailed description
The investigators will recruit up to 20 people with symptomatic knee osteoarthritis. The 20 eligible participants will attend 3 sessions in the laboratory. Session 1 is to collect data for Aim 1. Sessions 2 and 3 will include the rTMS interventions and data collection for Aim 2.
Aim 1 is a descriptive study to compare the neural (cortical and corticospinal) excitability of the quadriceps in the symptomatic knee to the asymptomatic knee in participants with knee osteoarthritis. The investigators will examine the associations between neural excitability and clinical measures of pain, strength, function, and coping styles.
Aim 2 is a double blind, crossover study design. Each participant will partake in two testing sessions, spaced 1 week apart. The investigators will evaluate outcome measures prior to and following the "true" intervention versus the "sham" intervention. The true intervention is rTMS + exercise. The sham is sham rTMS + exercise. The primary outcome measures are quadriceps strength, as measured from a maximal isometric voluntary contraction, and quadriceps central activation ratio (CAR), as calculated from the torque values from the voluntary strength measurement and a brief, intense electrical stimulus. Secondary measures evaluate effects of the intervention on 1) clinical measures of pain and functional performance, 2) corticospinal excitability, and 3) intracortical inhibition and facilitation.
- Conditions
- Osteoarthritis, Knee
- Being tested
- rTMS and exercise, Sham rTMS and exercise
- Keywords
- TMS, rTMS, corticospinal, quadriceps
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS and exerciseDevice
Also called repetitive TMS
rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)
Sham rTMS and exerciseDevice
Also called sham repetitive TMS
rTMS unit is on and running but mu metal is placed between the coil and the skull
| Study group | Role | What they receive |
|---|---|---|
| rTMS and exercise, then Sham rTMS and exercise | Experimental | At lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters. Receives: Device: rTMS and exercise; Device: Sham rTMS and exercise |
| Sham rTMS and exercise, then rTMS and exercise | Sham comparator | At lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters. Receives: Device: rTMS and exercise; Device: Sham rTMS and exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Central Activation Ratio (CAR)
Quadriceps Central Activation Ratio (CAR) is a percentage of the amount of torque produced during the superimposed burst technique using maximal voluntary isometric contraction (MVIC) and superimposed burst torque. It is reported on a scale of 0 (worst) to 100% (best) activation.
Measured: Within 1 hour post intervention
Quadriceps Maximal Voluntary Isometric Contraction (MVIC)
HUMAC NORM electromechanical dynamometer is used to measure isometric torque generation in quadriceps muscle stabilized with 70 degrees of knee flexion. Units of measure are in Newton meters (Nm).
Measured: Within 1 hour post intervention
Secondary outcomes (6)
Numeric Pain Rating Scale (NPRS) Score
Pain intensity is rated on a visual analog scale of 0-10 where 0 is no pain and 10 is maximum pain
Measured: Within 1 hour post intervention
Pressure Pain Threshold (PPT) - Medial Knee
Using the AlgoMed algometer, pressure at a rate of 35 kPA/second is applied to the medial knee to the level that subject indicates is painful. Units of measure are kilopascal (kPa)
Measured: Within 1 hour post intervention
Timed Up & Go (TUG)
Time in seconds to rise from a chair, walk 3 m, return and sit down
Measured: Within 1 hour post intervention
Active Motor Threshold Motor Evoked Potential (AMT-MEP)
The quadriceps active muscle responses (motor evoked potentials) that result from the single-pulse transcranial magnetic stimulation (TMS) pulses over the motor cortex. These AMT-MEP are measured peak-to-peak in microvolts (uV ). 10 AMT-MEP values were collected and averaged.
Measured: Within 1 hour post intervention
Short Interval Cortical Inhibition (SICI)
Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 3 ms interval, will be used. SICI is the ratio of the conditioning stimulus relative to the test stimulus. A ratio < 1.0 indicates inhibition.
Measured: Within 1 hour post intervention
Intra Cortical Facilitation (ICF)
Transcranial magnetic stimulation (TMS), using the conditioning-test paired-pulse paradigm with a 15 ms interval, will be used. ICF is the ratio of the conditioning stimulus relative to the test stimulus. A ratio > 1.0 indicates facilitation.
Measured: Within 1 hour post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion26 Jun 2018
- Study completion26 Jun 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.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Deborah L Givens, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881775
- Sponsor's protocol ID
- 16-0255
- Status last verified
- Mar 2019
- First submitted
- 15 Aug 2016
- Last updated
- 11 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of rTMS on Corticospinal Excitability of the Quadriceps in People With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02881775
- Acronym / sponsor ID
- 16-0255
- Conditions
- Osteoarthritis, Knee
- Keywords
- TMS, rTMS, corticospinal, quadriceps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- Sep 2016
- Primary completion
- 26 Jun 2018 (actual)
- Study completion
- 26 Jun 2018 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Posted 29 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to identify things that influence the ability to "turn on" the thigh muscle (quadriceps). The thigh muscle tends to be under active with knee osteoarthritis, which may make it difficult to strengthen the muscle. The investigators are also testing a new technology called repetitive transcranial magnetic stimulation (rTMS) to determine whether it may help "turn up" activity in the under active thigh muscle immediately after its application. rTMS uses a targeted pulsed magnetic field, similar to what is used in an MRI (magnetic resonance imaging) machine to send an electrical signal from the brain to the thigh muscle.
Detailed description
The investigators will recruit up to 20 people with symptomatic knee osteoarthritis. The 20 eligible participants will attend 3 sessions in the laboratory. Session 1 is to collect data for Aim 1. Sessions 2 and 3 will include the rTMS interventions and data collection for Aim 2.
Aim 1 is a descriptive study to compare the neural (cortical and corticospinal) excitability of the quadriceps in the symptomatic knee to the asymptomatic knee in participants with knee osteoarthritis. The investigators will examine the associations between neural excitability and clinical measures of pain, strength, function, and coping styles.
Aim 2 is a double blind, crossover study design. Each participant will partake in two testing sessions, spaced 1 week apart. The investigators will evaluate outcome measures prior to and following the "true" intervention versus the "sham" intervention. The true intervention is rTMS + exercise. The sham is sham rTMS + exercise. The primary outcome measures are quadriceps strength, as measured from a maximal isometric voluntary contraction, and quadriceps central activation ratio (CAR), as calculated from the torque values from the voluntary strength measurement and a brief, intense electrical stimulus. Secondary measures evaluate effects of the intervention on 1) clinical measures of pain and functional performance, 2) corticospinal excitability, and 3) intracortical inhibition and facilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS and exercise, then Sham rTMS and exercise | Experimental | Device: rTMS and exercise, Device: Sham rTMS and exerciseAt lab visit, subjects receive repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive sham rTMS and exercise using the same parameters. |
| Sham rTMS and exercise, then rTMS and exercise | Sham comparator | Device: rTMS and exercise, Device: Sham rTMS and exerciseAt lab visit, subjects receive sham repetitive transcranial magnetic stimulation (rTMS) at 10 Hz, 5 sec on, 55 sec off and quadriceps isometric exercise (5% MVIC) for 15 minutes. This is followed by a wash out period of 1 week. At the next lab visit, subjects receive the "true" rTMS and exercise using the same parameters. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- symptomatic knee osteoarthritis primarily involving one leg based on Western Ontario and McMaster Universities Arthritis Index (WOMAC) function subscale score > 10 (out of 100 points, indicating most dysfunction)
- diagnosis of knee osteoarthritis
- opposite knee with WOMAC pain score ≤ 5.
- opposite knee does not have a diagnosis of knee osteoarthritis
Key exclusion criteria (15 listed)
- conditions affecting the leg other than osteoarthritis
- low blood pressure (< 90 systolic, 60 diastolic) or heart rate (< 60 beats per minute)
- conditions that limit exercise tolerance such as a heart condition
- pregnant or planning to become pregnant in the next 3 months
- conditions that alter sensation and pain processing
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 |
|---|---|---|
| rTMS and exerciseAlso: repetitive TMSrTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC) | Device | Sham rTMS and exercise, then rTMS and exercise, rTMS and exercise, then Sham rTMS and exercise |
| Sham rTMS and exerciseAlso: sham repetitive TMSrTMS unit is on and running but mu metal is placed between the coil and the skull | Device | Sham rTMS and exercise, then rTMS and exercise, rTMS and exercise, then Sham rTMS and exercise |
Primary outcome
Quadriceps Central Activation Ratio (CAR)
Time frame: Within 1 hour post intervention
Quadriceps Central Activation Ratio (CAR) is a percentage of the amount of torque produced during the superimposed burst technique using maximal voluntary isometric contraction (MVIC) and superimposed burst torque. It is reported on a scale of 0 (worst) to 100% (best) activation.
Quadriceps Maximal Voluntary Isometric Contraction (MVIC)
Time frame: Within 1 hour post intervention
HUMAC NORM electromechanical dynamometer is used to measure isometric torque generation in quadriceps muscle stabilized with 70 degrees of knee flexion. Units of measure are in Newton meters (Nm).
6 secondary outcomes
Numeric Pain Rating Scale (NPRS) Score
Time frame: Within 1 hour post intervention
Pressure Pain Threshold (PPT) - Medial Knee
Time frame: Within 1 hour post intervention
Timed Up & Go (TUG)
Time frame: Within 1 hour post intervention
Active Motor Threshold Motor Evoked Potential (AMT-MEP)
Time frame: Within 1 hour post intervention
Short Interval Cortical Inhibition (SICI)
Time frame: Within 1 hour post intervention
Intra Cortical Facilitation (ICF)
Time frame: Within 1 hour post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Deborah L Givens, 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 rTMS and exercise in people with Osteoarthritis, Knee, 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 4 inclusion and 15 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 11 Jun 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. Some participants in this study may receive a placebo. 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 29 May 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?
Quadriceps Central Activation Ratio (CAR) (time frame: Within 1 hour post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2019.