NCT00976079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2009

Completed
Last Updated

September 14, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

September 11, 2009

Last Update Submit

September 11, 2009

Conditions

Tibial Femoral Knee OsteoarthritisOsteoarthritis

Keywords

Tibial femoral knee osteoarthritisOsteoarthritis

Outcome Measures

Primary Outcomes (2)

  • Quadriceps central activation ratio

    2 and 4 weeks

  • Quadriceps torque production

    2 and 4 weeks

Secondary Outcomes (3)

  • WOMAC score

    2 and 4 weeks

  • Visual analog pain score

    2 and 4 weeks

  • Knee joint kinetics and kinematics

    2 and 4 weeks

Study Arms (3)

Active TENS

EXPERIMENTAL

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

Device: Transcutaneous electrical nerve stimulation (TENS)

Placebo TENS

PLACEBO COMPARATOR

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

Device: Placebo TENS

Control Group

NO INTERVENTION

No TENS, standard physical therapy for 4 weeks.

Interventions

Transcutaneous electrical nerve stimulation (TENS)DEVICE

Continuous TENS use

Active TENS
Placebo TENSDEVICE

Placebo TENS use

Placebo TENS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Christopher Ingersoll, PhD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2009

First Posted

September 14, 2009

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

September 14, 2009

Record last verified: 2009-09

Locations

US(1)