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OsteoarthritisPhase 2NCT00800254

Early Neuromuscular Electrical Stimulation For Quadriceps Muscle Activation Deficits Following Total Knee Replacement

A Phase 2 study testing Neuromuscular Electrical Stimulation (NMES) and Standard Rehabilitation Protocol in people with Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and… Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Osteoarthritis
What is being tested?
Neuromuscular Electrical Stimulation (NMES) and Standard Rehabilitation Protocol
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteUnited States
Study dates
Oct 2008to Nov 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 50-85 years of age
  • Scheduled for a primary unilateral TKA
  • Cognitive status that allows patients to consistently comprehend and repeat back directions regarding the details of the study

Who cannot join

  • History of uncontrolled hypertension or uncontrolled diabetes
  • Body mass index greater than 35 kg/m^2
  • Neurological, vascular or cardiac problems that significantly limit function
  • Moderate or severe osteoarthritis or other orthopedic conditions in the non-operated lower extremity that limit function

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCD Physical Therapy Program

    Aurora, Colorado, 80045

Other trials in United States

About this study

The purpose of this study is to determine whether early intervention with neuromuscular electrical stimulation (NMES) for muscle strengthening immediately after total knee arthroplasty (TKA) is more effective than voluntary exercise alone in countering changes in quadriceps muscle activation, force production, and function in older adults.

Read the detailed description

Osteoarthritis (OA) is a chronic degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. To alleviate pain and disability associated with knee OA, over 400,000 total knee arthroplasty (TKA) are performed each year in the United States, and future projections indicate that by the year 2030, more than 750,000 TKAs will be performed per year. While TKA reliably reduces pain and improves function, the recovery of force and function to normal levels is rare, which predisposes patients to future disability with increasing age. A month after TKA, impairments in quadriceps force are predominantly due to reflex inhibition, but are also influenced, to a lesser degree, by muscle atrophy. Neuromuscular electrical stimulation (NMES) may offer a promising alternative approach to override quadriceps reflex inhibition and prevent muscle atrophy to restore normal quadriceps muscle function more effectively than voluntary exercise alone, especially when applied within the first days after surgery.

The overall goal of this study is to evaluate the efficacy of NMES initiated 48hrs after TKA as an adjunct to standard rehabilitation. NMES is expected to more effectively restore normal quadriceps muscle function to produce greater quadriceps force by decreasing reflex inhibition. Patients will be randomized into one of two rehabilitation groups: 1) the standard rehabilitation group or 2) standard rehabilitation + NMES.

Conditions
Osteoarthritis
Being tested
Neuromuscular Electrical Stimulation (NMES), Standard Rehabilitation Protocol
Keywords
electrical stimulation, total knee arthroplasty, quadriceps, muscle, arthroscopy
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular Electrical Stimulation (NMES)Device

    NMES 20 minutes twice a day for 6 weeks plus standard physical therapy

  • Standard Rehabilitation ProtocolOther

    Standard physical therapy for 8 weeks after surgery

Study groups in NCT00800254
Study groupRoleWhat they receive
Neuromuscular Electrical Stimulation (NMES)ExperimentalNot described
Receives: Device: Neuromuscular Electrical Stimulation (NMES)
Standard Rehabilitation ProtocolActive comparatorNot described
Receives: Other: Standard Rehabilitation Protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively

    A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.

    Measured: Baseline through 3.5 weeks

Secondary outcomes (7)

  1. Change From Baseline in Isometric Quadriceps Muscle Torque 1-Year Post-operatively

    A HUMAC NORM electromechanical dynamometer was used to measure isometric torque generation in quadriceps muscle stabilized with 60 degrees of knee flexion.

    Measured: Baseline through 1 year

  2. Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 3.5 Weeks Post-operatively

    The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.

    Measured: 3.5 weeks post-operatively

  3. Functional Performance Measure: Timed "Up & Go" Test [TUG] at 3.5 Weeks Post-operatively

    The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.

    Measured: 3.5 weeks post-operatively

  4. Functional Performance Measure: Stair-Climbing Test [SCT] at 3.5 Weeks Post-operatively

    The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.

    Measured: 3.5 weeks post-operatively

  5. Functional Performance Measure: Six-Minute Walk Test [6MWT]) at 1 Year Post-operatively

    The 6MWT assesses the total distance in meters a patient walks at a self-selected pace over a 6 minute interval.

    Measured: 1 year post-operatively

  6. Functional Performance Measure: Timed "Up & Go" Test [TUG] at 1 Year Post-operatively

    The TUG assesses time in seconds to rise from an armchair, walk 3 meters, turn around, and return to sitting in the same chair without physical assistance.

    Measured: 1 year post-operatively

  7. Functional Performance Measure: Stair-Climbing Test [SCT] at 1 Year Post-operatively

    The SCT assesses the time it takes for a patient to ascend a flight of stairs, turn around, and descend the same flight of stairs.

    Measured: 1 year post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionDec 2010
  4. Study completionNov 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00800254
Sponsor's protocol ID
06-0074
Other IDs
K23AG029978-01A2
Status last verified
Jul 2015
First submitted
30 Nov 2008
Last updated
11 Aug 2015
Data monitoring committee
No

Publications

  • Mintken PE, Carpenter KJ, Eckhoff D, Kohrt WM, Stevens JE. Early neuromuscular electrical stimulation to optimize quadriceps muscle function following total knee arthroplasty: a case report. J Orthop Sports Phys Ther. 2007 Jul;37(7):364-71. doi: 10.2519/jospt.2007.2541.

    PubMed 17710905

  • Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

    PubMed 15866968

  • Mizner RL, Petterson SC, Stevens JE, Axe MJ, Snyder-Mackler L. Preoperative quadriceps strength predicts functional ability one year after total knee arthroplasty. J Rheumatol. 2005 Aug;32(8):1533-9.

    PubMed 16078331

  • Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Schwartz RS, Schenkman M, Kohrt WM. Relationship between intensity of quadriceps muscle neuromuscular electrical stimulation and strength recovery after total knee arthroplasty. Phys Ther. 2012 Sep;92(9):1187-96. doi: 10.2522/ptj.20110479. Epub 2012 May 31.

    PubMed 22652985

  • Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.

    PubMed 22095207

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neuromuscular Electrical Stimulation (NMES) and Standard Rehabilitation Protocol in people with Osteoarthritis, run by University of Colorado, Denver at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Isometric Quadriceps Muscle Torque 3.5 Weeks Post-operatively (time frame: Baseline through 3.5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00800254, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.

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