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Completed

NCT Number: NCT00976079

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

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.

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Key information

Conditions

Tibial Femoral Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

Continuous TENS use

Placebo TENS

Device

Placebo TENS use

Primary outcomes

  1. Quadriceps central activation ratio

    Time frame: 2 and 4 weeks

  2. Quadriceps torque production

    Time frame: 2 and 4 weeks

Secondary outcomes

  1. WOMAC score

    Time frame: 2 and 4 weeks

  2. Visual analog pain score

    Time frame: 2 and 4 weeks

  3. Knee joint kinetics and kinematics

    Time frame: 2 and 4 weeks

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 14, 2009
Registry last updated
Sep 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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