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

This study has been completed.
Sponsor:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00976079
First received: September 11, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Tibial Femoral Knee Osteoarthritis
Osteoarthritis
Device: Transcutaneous electrical nerve stimulation (TENS)
Device: Placebo TENS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Quadriceps central activation ratio [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Quadriceps torque production [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC score [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Visual analog pain score [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]
  • Knee joint kinetics and kinematics [ Time Frame: 2 and 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976079

Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Investigators
Principal Investigator: Christopher Ingersoll, PhD University of Virginia
  More Information

No publications provided

Responsible Party: Christopher D. Ingersoll, PhD, University of Virginia
ClinicalTrials.gov Identifier: NCT00976079     History of Changes
Other Study ID Numbers: 13360
Study First Received: September 11, 2009
Last Updated: September 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by University of Virginia:
Tibial femoral knee osteoarthritis
Osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014