Tibial Femoral Knee OsteoarthritisNCT00976079
The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Tibial Femoral Knee Osteoarthritis and Osteoarthritis, run by University of Virginia at 1 site in United States.
Trial summary
Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and a control group. Assignment of conditions will be concealed. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tibial Femoral Knee Osteoarthritis, Osteoarthritis
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Aug 2009
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed with a Kellgren and Lawrence grade of 1- 4 for Tibial Femoral Knee OA in at least one leg or have been diagnosed with OA by a physician using evidence confirmed from imaging studies, arthroscopy, or visualization during an past surgical procedures, or have medical reports confirming OA using imaging studies, arthroscopy, or visualization during an past surgical procedures.
- Patients between the ages of 18 and 80 years of age.
- Patients will have a CAR less than 90%.
Who cannot join
- Patients who are pregnant.
- Patients who have sought medical attention for a trauma to the knee injury within the past 6 months.
- Patients who have had any orthopaedic lower extremity surgery in the past 6 months, or any surgery that would inhibition proper functioning of the study methodology.
- Patients with a diagnosis of Rheumatoid Arthritis.
- Patients with a known hypersensitivity to electrical stimulation.
- Patients with any types of neuropathy.
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- Patients with known muscular abnormalities.
- Patients with a history of a heart condition that precludes them from exercise.
- The technique can not be performed on the leg that has had a total knee replacement, but if the other leg meets the inclusion criteria the subject can perform the study on the non- reconstructed leg.
- Patients diagnosed with malignancy over the stimulating electrode site (thigh and knee).
- Patients with serious infection near the stimulating electrode sites (thigh and knee)
- Patients have not had a knee injection in the past 2 weeks.
- Patients who are unable to walk a series of 30 meters without a walking assistance device.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and a control group. Assignment of conditions will be concealed. All participants in each of the three groups will receive physical therapy for all 4 weeks of the intervention. Main outcome measures will include quadriceps central activation ratio, quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as knee joint kinetics and kinematics during gait. The purpose of this study is to to determine if the continuous use of TENS therapy for activities of daily living and rehabilitation will positively impact all outcome measures.
- Conditions
- Tibial Femoral Knee Osteoarthritis, Osteoarthritis
- Being tested
- Transcutaneous electrical nerve stimulation (TENS), Placebo TENS
- Keywords
- Tibial femoral knee osteoarthritis, Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous electrical nerve stimulation (TENS)Device
Continuous TENS use
Placebo TENSDevice
Placebo TENS use
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Experimental | Active TENS therapy for 4 weeks plus standard physical therapy for same time period. Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
| Placebo TENS | Placebo comparator | Placebo TENS for 4 weeks plus standard physical therapy for same time period. Receives: Device: Placebo TENS |
| Control Group | No intervention | No TENS, standard physical therapy for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps central activation ratio
Measured: 2 and 4 weeks
Quadriceps torque production
Measured: 2 and 4 weeks
Secondary outcomes (3)
WOMAC score
Measured: 2 and 4 weeks
Visual analog pain score
Measured: 2 and 4 weeks
Knee joint kinetics and kinematics
Measured: 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2009 (estimated)
- Study startNov 2007
- Primary completionMay 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibial Femoral Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- Christopher Ingersoll, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976079
- Sponsor's protocol ID
- 13360
- Status last verified
- Sep 2009
- First submitted
- 11 Sep 2009
- Last updated
- 14 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait
- ClinicalTrials.gov ID
- NCT00976079
- Acronym / sponsor ID
- 13360
- Conditions
- Tibial Femoral Knee Osteoarthritis, Osteoarthritis
- Keywords
- Tibial femoral knee osteoarthritis, Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 14 Sep 2009 (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.
Participants diagnosed with tibial femoral knee osteoarthritis will be assigned to one of three treatment groups including: active transcutaneous electrical nerve stimulation (TENS), placebo TENS, and a control group. Assignment of conditions will be concealed. All participants in each of the three groups will receive physical therapy for all 4 weeks of the intervention. Main outcome measures will include quadriceps central activation ratio, quadriceps torque production, WOMAC scores, visual analog pain scores during gait as well as knee joint kinetics and kinematics during gait. The purpose of this study is to to determine if the continuous use of TENS therapy for activities of daily living and rehabilitation will positively impact all outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Experimental | Device: Transcutaneous electrical nerve stimulation (TENS)Active TENS therapy for 4 weeks plus standard physical therapy for same time period. |
| Placebo TENS | Placebo comparator | Device: Placebo TENSPlacebo TENS for 4 weeks plus standard physical therapy for same time period. |
| Control Group | No intervention | –No TENS, standard physical therapy for 4 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have been diagnosed with a Kellgren and Lawrence grade of 1- 4 for Tibial Femoral Knee OA in at least one leg or have been diagnosed with OA by a physician using evidence confirmed from imaging studies, arthroscopy, or visualization during an past surgical procedures, or have medical reports confirming OA using imaging studies, arthroscopy, or visualization during an past surgical procedures.
- Patients between the ages of 18 and 80 years of age.
- Patients will have a CAR less than 90%.
Key exclusion criteria (13 listed)
- Patients who are pregnant.
- Patients who have sought medical attention for a trauma to the knee injury within the past 6 months.
- Patients who have had any orthopaedic lower extremity surgery in the past 6 months, or any surgery that would inhibition proper functioning of the study methodology.
- Patients with a diagnosis of Rheumatoid Arthritis.
- Patients with a known hypersensitivity to electrical stimulation.
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 stimulation (TENS)Continuous TENS use | Device | Active TENS |
| Placebo TENSPlacebo TENS use | Device | Placebo TENS |
Primary outcome
Quadriceps central activation ratio
Time frame: 2 and 4 weeks
Quadriceps torque production
Time frame: 2 and 4 weeks
3 secondary outcomes
WOMAC score
Time frame: 2 and 4 weeks
Visual analog pain score
Time frame: 2 and 4 weeks
Knee joint kinetics and kinematics
Time frame: 2 and 4 weeks
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 Sep 2009.
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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.
Christopher Ingersoll, PhD principal investigator
University of Virginia
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 (TENS) in people with Tibial Femoral Knee Osteoarthritis and Osteoarthritis, run by University of Virginia 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 3 inclusion and 13 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 Sep 2009. 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?
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?
Quadriceps central activation ratio (time frame: 2 and 4 weeks). 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 14 Sep 2009.