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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976079
• Other study ID #: 13360
• Status: Completed
• Phase: N/A
• First received: September 11, 2009
• Last updated: September 11, 2009
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Tibial Femoral Knee Osteoarthritis

Intervention

Device:
• Transcutaneous electrical nerve stimulation (TENS)
Continuous TENS use
• Placebo TENS
Placebo TENS use

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps central activation ratio		2 and 4 weeks	No
Primary	Quadriceps torque production		2 and 4 weeks	No
Secondary	WOMAC score		2 and 4 weeks	No
Secondary	Visual analog pain score		2 and 4 weeks	No
Secondary	Knee joint kinetics and kinematics		2 and 4 weeks	No