An Intervention of Electrical Stimulation in Osteoarthritis

July 18, 2016 updated by: Riann Palmieri-Smith, University of Michigan

The Efficacy of Neuromuscular Electrical Stimulation for Improving Quadriceps Activation in Women With Medial Tibiofemoral Osteoarthritis

Patients with knee osteoarthritis (OA) often have decreased thigh muscle strength. This muscle weakness is thought to originate from centers in the brain and spinal cord that restrict recruitment of fibers responsible for muscle contraction. An inability to fully contract muscles surrounding the knee joint impairs patients' abilities to perform activities of daily living (i.e. walking, climbing stairs) and may even contribute to further joint degeneration.

Establishing therapies aimed at increasing muscle strength, restoring normal function, and possibly slowing the processes involved in the development of knee OA is essential in order to enhance the quality of life in the adult population plagued with this degenerative joint condition.

Electrical muscle stimulation applied to the thigh is a promising therapy that has been shown to successfully restore muscle strength, however how long the treatment lasts and its influence on functional outcomes remains unknown. In order for electrical muscle stimulation to be of value it must result in sustained improvements in muscle strength and functional outcomes. Therefore, the purpose of the proposed investigation is to determine if electrical muscle stimulation can restore thigh muscle strength and improve functional outcomes in patients with knee osteoarthritis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A frequent clinical obstacle encountered in patients with knee osteoarthritis (OA) is an inability to achieve full voluntary activation of the quadriceps musculature. This phenomenon has been termed arthrogenic muscle inhibition (AMI) and is an ongoing reflex inhibition of musculature surrounding a joint following distension or damage to the structures of that joint. AMI is a limiting factor in joint rehabilitation as it restricts full muscle activation and therefore prevents restoration of strength. Thus, patients often participate in life activities deficient in strength and neuromuscular control resulting in altered lower extremity mechanics and potentially predisposing patients to further joint degeneration. Neuromuscular electrical stimulation (NMES) has been shown to be successful in reversing quadriceps AMI, however the duration of its effectiveness and its influence on functional outcomes remains elusive. Therefore, the purpose of the proposed study is to examine quadriceps activation and functional outcomes following a 4-week NMES protocol in patients with medial tibiofemoral osteoarthritis. To examine the efficacy of NMES in reversing AMI and improving functional outcomes, 38 subjects will be randomly assigned to either undergo a 4-week NMES program or to undergo no therapeutic intervention. Prior to treatment and at 1, 12, and 24 weeks following treatment, patients' quadriceps central activation ratios will be assessed. Additionally, subjects will undergo gait and stair climb analyses to determine if functional performance during these activities of daily living are improved when compared to the baseline assessment. Patients' perceived level of function will also be tested using the Western Ontario and McMasters Universities Osteoarthritis Index.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 62 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All participants must be female
  • Subjects must have radiographic osteoarthritis of grade 2 severity according to the Kellgren and Lawrence scale on the posterior-anterior semi-flexed view with definite osteophytes present in the medial and not lateral compartment.

Exclusion Criteria:

  • Previous adverse reaction to electrical stimulation
  • Inability to ambulate without the use of an assistive device (i.e cane, walker)
  • Patients who have undergone a total knee arthroplasty
  • Patients who have torn any knee ligament (ACL, PCL, MCL, LCL)
  • Enrollees who have a demand-type cardiac pacemaker or are pregnant
  • History of tibial osteotomy surgery
  • Significant peripheral or central nervous system disease
  • Concurrent clinically active arthritis of the hip, ankle, hindfoot or midfoot in either limb
  • Concurrent bilateral radiographic evidence of tibiofemoral osteoarthritis
  • Enrollees who are concurrently undergoing physical therapy for pain or OA
  • Enrollees who are taking Cox-2 inhibitors or are receiving corticosteroid injections
  • Subjects will be allowed to take buffered aspirin and naproxen sodium while enrolled in the study
  • Enrollees who have a body mass index of greater than 40 (morbidly obese)
  • Enrollees who have a CAR > .95 (e.g. patients whose quadriceps are uninhibited)
  • Enrollees who have previously undergone quadriceps NMES therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: No Treatment
No treatment was delivered to this arm. Participants went about activities of daily living
EXPERIMENTAL: Electrical Stimulation
Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks
Device: Electrical Stimulation
Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks
Other Names:
  • Vectra Genisys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks
Time Frame: Baseline and 12 weeks post-intervention
Knee extension Torque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus
Baseline and 12 weeks post-intervention
Change From Baseline in Quadriceps Strength at 12 Weeks
Time Frame: Baseline and 12 weeks following the intervention
Baseline and 12 weeks following the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in WOMAC Disability Score at 12 Weeks
Time Frame: baseline and 12 weeks post-intervention
Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)
baseline and 12 weeks post-intervention
Change From Baseline in Timed Walking Speed at 12 Weeks
Time Frame: Baseline and 12 weeks post-intervention
Baseline and 12 weeks post-intervention
Change From Baseline in WOMAC Pain Score at 12 Weeks
Time Frame: Baseline and 12 weeks following intervention
WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)
Baseline and 12 weeks following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

Arthritis Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

July 10, 2007

First Submitted That Met QC Criteria

July 10, 2007

First Posted (ESTIMATE)

July 12, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 29, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-Palmieri-Smith

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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