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An Intervention of Electrical Stimulation in Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00500448
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : August 29, 2016
Last Update Posted : August 29, 2016
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by (Responsible Party):
Riann Palmieri-Smith, University of Michigan

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Electrical Stimulation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Neuromuscular Electrical Stimulation for Improving Quadriceps Activation in Women With Medial Tibiofemoral Osteoarthritis
Study Start Date : July 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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 Name: Vectra Genisys


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Change From Baseline in Quadriceps Strength at 12 Weeks [ Time Frame: Baseline and 12 weeks following the intervention ]

Secondary Outcome Measures :
  1. 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)

  2. Change From Baseline in Timed Walking Speed at 12 Weeks [ Time Frame: Baseline and 12 weeks post-intervention ]
  3. 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)


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 62 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500448


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Arthritis Foundation
Investigators
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Principal Investigator: Riann M Palmieri-Smith, PhD University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Riann Palmieri-Smith, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00500448    
Other Study ID Numbers: 1-Palmieri-Smith
First Posted: July 12, 2007    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: August 29, 2016
Last Verified: July 2016
Keywords provided by Riann Palmieri-Smith, University of Michigan:
Arthritis, Knee, Quadriceps, Electrical Stimulation, Women
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases