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The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait

The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00976079
Enrollment
49
Registered
2009-09-14
Start date
2007-11-30
Completion date
2009-08-31
Last updated
2009-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tibial Femoral Knee Osteoarthritis, Osteoarthritis

Keywords

Tibial femoral knee osteoarthritis, Osteoarthritis

Brief 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. 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.

Interventions

DEVICETranscutaneous electrical nerve stimulation (TENS)

Continuous TENS use

Placebo TENS use

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 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%.

Exclusion criteria

* 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. * 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.

Design outcomes

Primary

MeasureTime frame
Quadriceps central activation ratio2 and 4 weeks
Quadriceps torque production2 and 4 weeks

Secondary

MeasureTime frame
WOMAC score2 and 4 weeks
Visual analog pain score2 and 4 weeks
Knee joint kinetics and kinematics2 and 4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026