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Clinical Trials/NCT00976079
NCT00976079
Completed
Not Applicable

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

University of Virginia1 site in 1 country49 target enrollmentNovember 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tibial Femoral Knee Osteoarthritis
Sponsor
University of Virginia
Enrollment
49
Locations
1
Primary Endpoint
Quadriceps central activation ratio
Status
Completed
Last Updated
16 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2007
End Date
August 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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).

Outcomes

Primary Outcomes

Quadriceps central activation ratio

Time Frame: 2 and 4 weeks

Quadriceps torque production

Time Frame: 2 and 4 weeks

Secondary Outcomes

  • WOMAC score(2 and 4 weeks)
  • Visual analog pain score(2 and 4 weeks)
  • Knee joint kinetics and kinematics(2 and 4 weeks)

Study Sites (1)

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