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| Name | Class |
|---|---|
| Arthritis Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrical Stimulation | Device | Electrical Stimulation (NMES) will be delivered 3 times per week for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline and 12 weeks post-intervention |
| Change From Baseline in Timed Walking Speed at 12 Weeks |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Riann M Palmieri-Smith, PhD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20671100 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Treatment | No treatment was delivered to this arm. Participants went about activities of daily living |
| FG001 | Neuromuscular Electrical Stimulation | Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Treatment | No treatment was delivered to this arm. Participants went about activities of daily living |
| BG001 | Neuromuscular Electrical Stimulation | Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | 95% Confidence Interval | unitless | Baseline and 12 weeks post-intervention |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Treatment | No treatment was delivered to this arm. Participants went about activities of daily living |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Riann Palmieri-Smith | University of Michigan | 7346153154 | riannp@umich.edu |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
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| 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) | Baseline and 12 weeks following intervention |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Mass | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg^m2 |
|
| Quadriceps Strength | Mean | Standard Deviation | Nm/kg |
|
| Central Activation Ratio (CAR) | Knee extensionTorque recorded during voluntary contraction/Knee extension torque recorded during contraction with superimposed stimulus | Mean | Standard Deviation | ratio |
|
| WOMAC Pain Score | WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain) | Mean | Standard Deviation | units on a scale (range 5-25) |
|
| WOMAC disability scale | WOMAC Disability Score ranges from 17 (no loss of function) to 85 (severe loss of function) | Mean | Standard Deviation | units on a scale (range 17-85) |
|
| Timed Walking speed | Mean | Standard Deviation | m/s |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | units on a scale | baseline and 12 weeks post-intervention |
|
|
|
| Secondary | Change From Baseline in Timed Walking Speed at 12 Weeks | Posted | Mean | 95% Confidence Interval | m/s | Baseline and 12 weeks post-intervention |
|
|
|
| Secondary | Change From Baseline in WOMAC Pain Score at 12 Weeks | WOMAC Pain Score ranges from 5 (no pain) to 25 (worst possible pain) | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 weeks following intervention |
|
|
|
| Primary | Change From Baseline in Quadriceps Strength at 12 Weeks | Posted | Mean | 95% Confidence Interval | Nm/kg | Baseline and 12 weeks following the intervention |
|
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| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Neuromuscular Electrical Stimulation | Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks | 0 | 16 | 0 | 16 |
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