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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Tibial Femoral Knee Osteoarthritis
• Intervention / Treatment: Device: Transcutaneous electrical nerve stimulation (TENS); Device: Placebo TENS

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TENS; Active TENS therapy for 4 weeks plus standard physical therapy for same time period.	Device: Transcutaneous electrical nerve stimulation (TENS); Continuous TENS use
Placebo Comparator: Placebo TENS; Placebo TENS for 4 weeks plus standard physical therapy for same time period.	Device: Placebo TENS; Placebo TENS use
No Intervention: Control Group; No TENS, standard physical therapy for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quadriceps central activation ratio	2 and 4 weeks
Quadriceps torque production	2 and 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
WOMAC score	2 and 4 weeks
Visual analog pain score	2 and 4 weeks
Knee joint kinetics and kinematics	2 and 4 weeks

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Christopher Ingersoll, PhD, University of Virginia

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: September 11, 2009
• First Submitted That Met QC Criteria: September 11, 2009
• First Posted (Estimate): September 14, 2009

Study Record Updates

• Last Update Posted (Estimate): September 14, 2009
• Last Update Submitted That Met QC Criteria: September 11, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Osteoarthritis; Tibial femoral knee osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 13360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No