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

Primary Purpose

Tibial Femoral Knee Osteoarthritis, Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
Placebo TENS
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tibial Femoral Knee Osteoarthritis focused on measuring Tibial femoral knee osteoarthritis, Osteoarthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Active TENS

Placebo TENS

Control Group

Arm Description

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

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

No TENS, standard physical therapy for 4 weeks.

Outcomes

Primary Outcome Measures

Quadriceps central activation ratio
Quadriceps torque production

Secondary Outcome Measures

WOMAC score
Visual analog pain score
Knee joint kinetics and kinematics

Full Information

First Posted
September 11, 2009
Last Updated
September 11, 2009
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT00976079
Brief Title
The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait
Official Title
The Effect of Transcutaneous Electrical Nerve Stimulation on Quadriceps Central Activation and Gait
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tibial Femoral Knee Osteoarthritis, Osteoarthritis
Keywords
Tibial femoral knee osteoarthritis, Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active TENS
Arm Type
Experimental
Arm Description
Active TENS therapy for 4 weeks plus standard physical therapy for same time period.
Arm Title
Placebo TENS
Arm Type
Placebo Comparator
Arm Description
Placebo TENS for 4 weeks plus standard physical therapy for same time period.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No TENS, standard physical therapy for 4 weeks.
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
Continuous TENS use
Intervention Type
Device
Intervention Name(s)
Placebo TENS
Intervention Description
Placebo TENS use
Primary Outcome Measure Information:
Title
Quadriceps central activation ratio
Time Frame
2 and 4 weeks
Title
Quadriceps torque production
Time Frame
2 and 4 weeks
Secondary Outcome Measure Information:
Title
WOMAC score
Time Frame
2 and 4 weeks
Title
Visual analog pain score
Time Frame
2 and 4 weeks
Title
Knee joint kinetics and kinematics
Time Frame
2 and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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%. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Ingersoll, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

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

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