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

NCT ID: NCT00976079

Last Updated: 2009-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2009-08-31

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.

Conditions

Tibial Femoral Knee Osteoarthritis; Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active TENS

Active TENS therapy for 4 weeks plus standard physical therapy for same time period.

Group Type: EXPERIMENTAL

Transcutaneous electrical nerve stimulation (TENS)

Intervention Type: DEVICE

Continuous TENS use

Placebo TENS

Placebo TENS for 4 weeks plus standard physical therapy for same time period.

Group Type: PLACEBO_COMPARATOR

Placebo TENS

Intervention Type: DEVICE

Placebo TENS use

Control Group

No TENS, standard physical therapy for 4 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transcutaneous electrical nerve stimulation (TENS)

Continuous TENS use

Intervention Type: DEVICE

Placebo TENS

Placebo TENS use

Intervention Type: DEVICE

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%.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

University of Virginia

Principal Investigators

Christopher Ingersoll, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

13360

Identifier Type: -

Identifier Source: org_study_id