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The focus of this project is to use transcutaneous electrical nerve stimulation (TENS) for the novel indication of treating neuromuscular activation in individuals with knee osteoarthritis (OA) that exhibit neuromuscular activation deficits. The overall goal is to improve outcomes associated traditional therapeutic exercise (TE) by developing an enhanced rehabilitation strategy, which augments TE with TENS (TENS+TE), for the purpose of treating underlying neuromuscular activation deficits. The investigators seek to use TENS to excite neural pathways that immediately increase neuromuscular activation as well as cause sustained improvements in neuromuscular activation and greater strength gains in knee OA patients compared to traditional TE. The investigators will evaluate the effect of TENS+TE on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self-reported quality of life, disability and pain. The central hypothesis is that an enhanced TENS+TE intervention will lead to better clinical outcomes, increased physical activity, and improved general health. The rationale for conducting a small clinical trial, which demonstrates the feasibility and establishes the preliminary effects of an enhanced rehabilitation strategy, is ultimately to inform the development of a future larger clinical trial to establish the efficacy of an enhanced rehabilitation strategy for knee OA. This hypothesis will be tested through two specific aims: 1) to collect and report data on the feasibility of conducting a clinical trial to evaluate the efficacy of using TENS+TE compared to sham TENS+TE and to TE only for treating patients with knee OA in a clinical setting, and 2) to determine preliminary effects of a 4-week TENS+TE intervention compared to sham TENS+TE, and TE only on muscle strength, neuromuscular activation, gait biomechanics, physical function, physical activity, self-efficacy of physical activity, self reported quality of life, disability, and pain in knee OA patients. Posttests will be at 4 and 8-weeks following baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TENS and Therapeutic Exercise | Experimental | Patients assigned to the TENS+Therapeutic Exercise (TE) group will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN), and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
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| Sham TENS and Therapeutic Exercise | Sham Comparator | Sham TENS+TE patients will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN) specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
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| Therapeutic Exercise Only | Active Comparator | The role of the comparison group is to provide data on how traditional TE affects the outcome measures. The TE only group will allow us to assess how the addition of TENS to traditional TE will augment the effects of traditional TE. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutaneous Electrical Nerve Stimulation | Device | TENS is FDA approved for the purposes in which we will be applying the modality (21CFR882.5890; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=882.5890, these TENS Units have been acquired by the PI, who is a licensed Allied Health Professional in the state of North Carolina). |
| Measure | Description | Time Frame |
|---|---|---|
| Mean in Self-reported Disability Score as Measured by the Western Ontario and McMasters Universities Index Between Groups | The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations. | 8-weeks from Baseline |
| Mean Voluntary Quadriceps Activation as Measured by the Central Activation Ratio Expressed as a Percent of Full Activation | The investigators assessed voluntary quadriceps central activation ratio as a representative variable of lower extremity neuromuscular activation using the supra imposition technique. Quadriceps central activation ratio has been demonstrated to be significantly decreased in knee osteoarthritis (OA) compared to healthy, matched controls, and the investigators have reported acceptable measurement reliability (ICC2,k = 0.85) | 8-weeks from Baseline |
| Mean Maximal Quadriceps Strength as Measured by the Maximal Isometric Voluntary Contractions Normalized to Body Weight | Quadriceps strength was measured in Newton Meters normalized to body weight of the individuals. Strength was assessed in 90 degrees of knee flexion. | 8-weeks from Baseline |
| Mean Internal Knee Extension Moment During Walking Gait Measured in Nm/ Body Weight*m |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Pietrosimone, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TENS and Therapeutic Exercise | Patients assigned to this group will receive a Select System TENS (i.e., transcutaneous electrical nerve stimulation TENS) unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2015 |
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| Therapeutic Exercise | Other | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. The intervention will consist of 10 45-minute sessions. |
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| Sham Transcutaneous Electrical Nerve Stimulation | Device | Sham TENS+TE patients will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN) specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. |
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The peak internal knee extension moment was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and normalized to the Body Weight* height (m) of the individual during self selected gait speed.
| 8-weeks from Baseline |
| Mean Knee Flexion Angle During Walking Gait Measured in Degrees of Knee Flexion | The peak Knee Flexion Angle was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and during self selected gait speed. | 8-weeks from Baseline |
| FG001 | Sham TENS and Therapeutic Exercise | Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of traditional therapeutic exercise (TE) will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
| FG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TENS and Therapeutic Exercise | Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. |
| BG001 | Sham TENS and Therapeutic Exercise | Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
| BG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Mean in Self-reported Disability Score as Measured by the Western Ontario and McMasters Universities Index Between Groups | The Western Ontario and McMasters Universities Index is reliable and valid measure of self reported disability. The physical function consists of 17 items and asks about the magnitude of difficulty when ascending and descending stairs, rising from sitting, standing, bending, walking, getting in / out of a car, shopping, putting on and taking off socks, rising from bed, lying in bed, getting in and out of the bath, sitting, getting on and off the toilet, completing heavy household duties, and completing light household duties. Each item is presented in a 5 point Likert-type format and uses the following descriptors for possible answer choices none, mild moderate, severe, and extreme. Each descriptor corresponds to an ordinal scale of 0-4. The scores are summed for the items in each subscale, with total possible ranges as 0-68. Higher scores on the WOMAC indicate greater amounts of functional limitations. | A proportion of the participants were lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | 8-weeks from Baseline |
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| Primary | Mean Voluntary Quadriceps Activation as Measured by the Central Activation Ratio Expressed as a Percent of Full Activation | The investigators assessed voluntary quadriceps central activation ratio as a representative variable of lower extremity neuromuscular activation using the supra imposition technique. Quadriceps central activation ratio has been demonstrated to be significantly decreased in knee osteoarthritis (OA) compared to healthy, matched controls, and the investigators have reported acceptable measurement reliability (ICC2,k = 0.85) | Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and participants electing not to undergo voluntary quadriceps activation. | Posted | Mean | Standard Deviation | percentage of full activation | 8-weeks from Baseline |
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| Primary | Mean Maximal Quadriceps Strength as Measured by the Maximal Isometric Voluntary Contractions Normalized to Body Weight | Quadriceps strength was measured in Newton Meters normalized to body weight of the individuals. Strength was assessed in 90 degrees of knee flexion. | Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and participants electing not to undergo voluntary quadriceps activation. | Posted | Mean | Standard Deviation | Nm/kg body weight | 8-weeks from Baseline |
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| Primary | Mean Internal Knee Extension Moment During Walking Gait Measured in Nm/ Body Weight*m | The peak internal knee extension moment was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and normalized to the Body Weight* height (m) of the individual during self selected gait speed. | Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and measurable outcomes were unable to be analyzed due to error in positioning of knee joint center marker. | Posted | Mean | Standard Deviation | Nm/ Body Weight *m | 8-weeks from Baseline |
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| Primary | Mean Knee Flexion Angle During Walking Gait Measured in Degrees of Knee Flexion | The peak Knee Flexion Angle was calculated using using inverse dynamics calculations in the first 50% of the stance phase of gait and during self selected gait speed. | Difference in baseline individuals and number of participants are due to a proportion of patients lost to follow up and measurable outcomes were unable to be analyzed due to error in positioning of knee joint center marker. | Posted | Mean | Standard Deviation | degrees | 8-weeks from Baseline |
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Adverse events were collected through 8 weeks following Baseline.
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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 | TENS and Therapeutic Exercise | Patients assigned to this group will receive a Select System TENS unit, and 8 hours of TENS per day (150 pulses per second, 150 msec phase duration at a patient-perceived strong sensory intensity). Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG001 | Sham TENS and Therapeutic Exercise | Patients will receive a Select System TENS unit specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become "sub-sensory" in nature. The participants will wear the Sham TENS for 8 hours per day. Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. | 0 | 29 | 0 | 29 | 0 | 29 |
| EG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. | 0 | 29 | 0 | 29 | 0 | 29 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Pietrosimone, PhD | University of North Carolina at Chapel Hill | 919-962-3617 | brian@unc.edu |
| Jan 25, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
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| OG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
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| OG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
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| OG002 | Therapeutic Exercise Only | Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. |
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