Knee OsteoarthritisNCT02036866
Corticospinal Excitability and Rehab in Knee Osteoarthritis
A study testing Transcutaneous Electrical Nerve Stimulation and Physical Therapy Exercises in people with Knee Osteoarthritis, run by Creighton University at 1 site in United States.
Trial summary
To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation and Physical Therapy Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 19-65
- Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at least one of the following:
- Age > 50 years old
- Morning stiffness < 30 minutes
- Crepitus
- Meet at least 3 of 6 diagnostic criteria for osteoarthritis:
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- Age > 50 years old
- Morning stiffness < 30 minutes
- Crepitus
- Bony tenderness
- Bony enlargement
- No palpable warmth
Who cannot join
- BMI > 30
- History of traumatic spine or lower extremity injury within the last 6 months
- Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
- Cardiac pacemaker
- Metal implants in head
- Current pregnancy
Show all 9Show fewer
- Neurological disorders
- History of seizures
- Unable to give consent or understand the procedures of this study
Trial locations and contacts
1 site in 1 country.
About this study
To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.
Read the detailed description
The primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. A secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. We hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. A 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. We further hypothesize that part of this improvement will be attributed to positive treatment expectation.
- Conditions
- Knee Osteoarthritis
- Being tested
- Transcutaneous Electrical Nerve Stimulation, Physical Therapy Exercises, No Intervention
- Keywords
- knee osteoarthritis, grade I and II knee osteoarthritis, arthritis
- Medical subject headings
- Osteoarthritis, Knee, Lymphoma, Follicular, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve StimulationOther
Also called TENS, Sensory TENS
The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 8 hours per day for 1 week.
Physical Therapy ExercisesOther
Patients will be given detailed verbal and hands-on instruction in a home exercise program. This program will consist of 6 exercises modeled from established protocols focuses on improving lower extremity strength. Patients will be instructed to do the exercises daily and to progress the exercises over the week for a maximum of 30 repetitions per day for 1 week.
No InterventionOther
Patients will be instructed to maintain their usual activity level.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy Positive Expectation | Experimental | The physical therapist will read a script indicating that the intervention is an effective treatment for knee osteoarthritis and is expected to reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS (transcutaneous electrical nerve stimulation) unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily. Receives: Other: Transcutaneous Electrical Nerve Stimulation; Other: Physical Therapy Exercises |
| Physical Therapy Neutral Expectation | Experimental | The physical therapist will read a script indicating that the intervention may or may not be an effective treatment for knee osteoarthritis and may nor may not reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily. Receives: Other: Transcutaneous Electrical Nerve Stimulation; Other: Physical Therapy Exercises |
| Control- No Intervention | Experimental | The patients in the control group will be reminded of their appointment in 1 week and instructed to maintain their usual activity level during that time. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quadriceps force output and voluntary activation
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.
Measured: Baseline and following 1 week intervention (2 Study Visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terry L Grindstaff, PhD, PT, ATC, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036866
- Sponsor's protocol ID
- 13-16794
- Status last verified
- Dec 2015
- First submitted
- 13 Jan 2014
- Last updated
- 14 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticospinal Excitability and Rehab in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02036866
- Acronym / sponsor ID
- 13-16794
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, grade I and II knee osteoarthritis, arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 15 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine differences in thigh muscle function in individuals with and without knee arthritis, and also determine the effectiveness of common physical therapy interventions on clinical and patient oriented outcomes.
Detailed description
The primary objective of the proposed research evaluates the concurrent changes in corticospinal excitability and central sensitization of pain pathways for their influence on quadriceps voluntary activation. A secondary objective is to establish the feasibility of an intervention study to determine if changes in the excitability of these supraspinal motor and sensory processes can be modified by physical therapy interventions targeting pain and muscle strengthening. We hypothesize that patients with knee osteoarthritis will show measurable deficits in quadriceps voluntary activation that can be explained by lower levels of corticospinal excitability and increased pain sensitization. A 1 week physical therapy intervention will improve voluntary activation and reduce pain with concurrent changes in underlying motor and sensory processes. We further hypothesize that part of this improvement will be attributed to positive treatment expectation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy Positive Expectation | Experimental | Other: Transcutaneous Electrical Nerve Stimulation, Other: Physical Therapy ExercisesThe physical therapist will read a script indicating that the intervention is an effective treatment for knee osteoarthritis and is expected to reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS (transcutaneous electrical nerve stimulation) unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily. |
| Physical Therapy Neutral Expectation | Experimental | Other: Transcutaneous Electrical Nerve Stimulation, Other: Physical Therapy ExercisesThe physical therapist will read a script indicating that the intervention may or may not be an effective treatment for knee osteoarthritis and may nor may not reduce pain and improve strength. Patients are then instructed on the home exercise program and how to operate the TENS unit. The duration of intervention is 1 week during which patients will wear then wear the TENS unit for 8 hours per day and perform no more than 3 sets of 10 repetitions of the physical therapy exercises daily. |
| Control- No Intervention | Experimental | Other: No InterventionThe patients in the control group will be reminded of their appointment in 1 week and instructed to maintain their usual activity level during that time. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 19-65
- Grade I or II knee Osteoarthritis confirmed by radiographs or other imaging and at least one of the following:
- Meet at least 3 of 6 diagnostic criteria for osteoarthritis:
Key exclusion criteria (9 listed)
- BMI > 30
- History of traumatic spine or lower extremity injury within the last 6 months
- Previous adverse reaction to electrical stimulation (i.e. burns or hypersensitivity)
- Cardiac pacemaker
- Metal implants in head
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 |
|---|---|---|
| Transcutaneous Electrical Nerve StimulationAlso: TENS, Sensory TENSThe TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 8 hours per day for 1 week. | Other | Physical Therapy Neutral Expectation, Physical Therapy Positive Expectation |
| Physical Therapy ExercisesPatients will be given detailed verbal and hands-on instruction in a home exercise program. This program will consist of 6 exercises modeled from established protocols focuses on improving lower extremity strength. Patients will be instructed to do the exercises daily and to progress the exercises over the week for a maximum of 30 repetitions per day for 1 week. | Other | Physical Therapy Neutral Expectation, Physical Therapy Positive Expectation |
| No InterventionPatients will be instructed to maintain their usual activity level. | Other | Control- No Intervention |
Primary outcome
Change in quadriceps force output and voluntary activation
Time frame: Baseline and following 1 week intervention (2 Study Visits)
Quadriceps activation will be estimated by utilizing the burst-superimposition technique on a maximum voluntary isometric contraction (MVIC) and during a resting condition. The burst-superimposition technique provides the muscle with a percutaneous stimulus to recruit any remaining muscle fibers which have not been stimulated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2015.
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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.
Terry L Grindstaff, PhD, PT, ATC principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation and Physical Therapy Exercises in people with Knee Osteoarthritis, run by Creighton University 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 12 inclusion and 9 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 14 Dec 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in quadriceps force output and voluntary activation (time frame: Baseline and following 1 week intervention (2 Study Visits)). 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 14 Dec 2015.