Clinical trial NCT00976079: The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait
Official title: The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tibial Femoral Knee Osteoarthritis
Osteoarthritis
Keywords: Tibial femoral knee osteoarthritis
Osteoarthritis
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2009-09-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Quadriceps central activation ratio
timeFrame: 2 and 4 weeks
measure: Quadriceps torque production
timeFrame: 2 and 4 weeks
Secondary outcomes:
measure: WOMAC score
timeFrame: 2 and 4 weeks
measure: Visual analog pain score
timeFrame: 2 and 4 weeks
measure: Knee joint kinetics and kinematics
timeFrame: 2 and 4 weeks
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Christopher Ingersoll, PhD
role: PRINCIPAL_INVESTIGATOR
References: