An Intervention of Electrical Stimulation in Osteoarthritis

NCT00500448 | Completed Results

• 1 other identifier: 1-Palmieri-Smith
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Arthritis, Knee, Quadriceps, Electrical Stimulation, Women

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Quadriceps Central Activation Ratio at 12 Weeks

  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

  Baseline and 12 weeks following the intervention

Secondary Outcomes (3)

• Change From Baseline in WOMAC Disability Score at 12 Weeks

  baseline and 12 weeks post-intervention

• Change From Baseline in Timed Walking Speed at 12 Weeks

  Baseline and 12 weeks post-intervention

• Change From Baseline in WOMAC Pain Score at 12 Weeks

  Baseline and 12 weeks following intervention

Study Arms (2)

No Treatment

NO INTERVENTION

No treatment was delivered to this arm. Participants went about activities of daily living

Electrical Stimulation

EXPERIMENTAL

Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks

Device: Electrical Stimulation

Interventions

Electrical Stimulation DEVICE

Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks

Also known as: Vectra Genisys

Electrical Stimulation

Eligibility Criteria

• Age: 50 Years - 62 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Arthritis Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Palmieri-Smith RM, Thomas AC, Karvonen-Gutierrez C, Sowers M. A clinical trial of neuromuscular electrical stimulation in improving quadriceps muscle strength and activation among women with mild and moderate osteoarthritis. Phys Ther. 2010 Oct;90(10):1441-52. doi: 10.2522/ptj.20090330. Epub 2010 Jul 29.

  PMID: 20671100 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Arthritis

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Results Point of Contact

• Title: Riann Palmieri-Smith
• Organization: University of Michigan

riannp@umich.edu

7346153154

Study Officials

• Riann M Palmieri-Smith, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: July 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 29, 2016
• Results First Posted: August 29, 2016

Record last verified: 2016-07

Locations

US (1)