OsteoarthritisNCT00500448
An Intervention of Electrical Stimulation in Osteoarthritis
A study testing Electrical Stimulation in people with Osteoarthritis, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 62 years, women only
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2009
- Phase
- Interventional
- 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 62 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Electrical Stimulation
- Keywords
- Arthritis, Knee, Quadriceps, Electrical Stimulation, Women
- Medical subject headings
- Osteoarthritis, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical StimulationDevice
Also called Vectra Genisys
Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 12 weeks post-intervention
Change From Baseline in Quadriceps Strength at 12 Weeks
Measured: Baseline and 12 weeks following the intervention
Secondary outcomes (3)
Change From Baseline in WOMAC Disability Score at 12 Weeks
Womac Disability Score is on a scale from 17 (no functional loss) to 85 (severe functional loss)
Measured: baseline and 12 weeks post-intervention
Change From Baseline in Timed Walking Speed at 12 Weeks
Measured: Baseline and 12 weeks post-intervention
Change From Baseline in WOMAC Pain Score at 12 Weeks
WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain)
Measured: Baseline and 12 weeks following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation
- Responsible party
- Principal investigator, Riann Palmieri-Smith, University of Michigan
- Investigators
- Riann M Palmieri-Smith, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500448
- Sponsor's protocol ID
- 1-Palmieri-Smith
- Status last verified
- Jul 2016
- First submitted
- 10 Jul 2007
- Last updated
- 29 Aug 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20671100
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Neuromuscular Electrical Stimulation for Improving Quadriceps Activation in Women With Medial Tibiofemoral Osteoarthritis
- ClinicalTrials.gov ID
- NCT00500448
- Acronym / sponsor ID
- 1-Palmieri-Smith
- Conditions
- Osteoarthritis
- Keywords
- Arthritis, Knee, Quadriceps, Electrical Stimulation, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Arthritis Foundation
- Study start
- Jul 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 12 Jul 2007 (estimated)
- Results
- Posted 29 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Treatment | No intervention | –No treatment was delivered to this arm. Participants went about activities of daily living |
| Electrical Stimulation | Experimental | Device: Electrical StimulationNeuromuscular electrical stimulation treatments 3 times per week for 4 weeks |
Who may qualify
- Ages
- 50 to 62 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical StimulationAlso: Vectra GenisysElectrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks | Device | Electrical Stimulation |
Primary outcome
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
Change From Baseline in Quadriceps Strength at 12 Weeks
Time frame: Baseline and 12 weeks following the intervention
3 secondary outcomes
Change From Baseline in WOMAC Disability Score at 12 Weeks
Time frame: baseline and 12 weeks post-intervention
Change From Baseline in Timed Walking Speed at 12 Weeks
Time frame: Baseline and 12 weeks post-intervention
Change From Baseline in WOMAC Pain Score at 12 Weeks
Time frame: Baseline and 12 weeks following intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20671100Palmieri-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Riann M Palmieri-Smith, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical Stimulation in people with Osteoarthritis, run by University of Michigan 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 2 inclusion and 15 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 29 Aug 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2016). 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 Quadriceps Central Activation Ratio at 12 Weeks (time frame: Baseline and 12 weeks post-intervention). The study lists 2 primary outcomes in all. 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 NCT00500448, which also lists 1 linked publication.
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 29 Aug 2016.