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Following standard of care procedures for arthroscopy knee surgery it is anticipated that Transcutaneous Electrical Nerve Stimulation (TENS) will provide improved pain relief and improve functional outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Structured TENS Therapy | Active Comparator | This group will be given an active TENS unit to use. |
|
| Sham TENS Therapy | Sham Comparator | This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TENS Treatment with functional or disabled unit | Device | TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain | Two weeks postoperatively. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Marberry, MD | A.T. Still University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Missouri Sports Medicine and Orthopaedic Surgery | Kirksville | Missouri | 63501 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14716650 | Background | Breit R, Van der Wall H. Transcutaneous electrical nerve stimulation for postoperative pain relief after total knee arthroplasty. J Arthroplasty. 2004 Jan;19(1):45-8. doi: 10.1016/s0883-5403(03)00458-3. | |
| 11688592 | Background | Lewek M, Stevens J, Snyder-Mackler L. The use of electrical stimulation to increase quadriceps femoris muscle force in an elderly patient following a total knee arthroplasty. Phys Ther. 2001 Sep;81(9):1565-71. doi: 10.1093/ptj/81.9.1565. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Structured TENS Therapy | This group will be given an active TENS unit to use. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
| FG001 | Sham TENS Therapy | This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Structured TENS Therapy | This group will be given an active TENS unit to use. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
| BG001 |
| 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 | Patient's Perception of Pain in the Early Post-operative Period While Utilizing Structured TENS Therapy. | The patient participant will record pain levels during the immediate post-op 2-week time period every day. Day 0 is pain level before surgery. Pain perception measured on a scale from 0-10 with 0 representing no or lowest level pain and 10 representing the highest level of pain | Posted | Least Squares Mean | 95% Confidence Interval | score on 0-10 pain level scale | Two weeks postoperatively. |
|
2 weeks
Transcutaneous Electrical Nerve Stimulation (TENS) therapy is considered an appropriate non-pharmacologic adjunct for the treatment of symptomatic knee arthritis. Since the electrical stimulation applied is minimal, the participants were at no risk of adverse events.
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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 | Structured TENS Therapy | This group will be given an active TENS unit to use. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corey Luebbering | A.T. Still University | 660.626.2147 | coreyluebbering@atsu.edu |
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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 | Apr 1, 2011 | Jan 10, 2019 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2011 | Jan 10, 2019 | ICF_001.pdf |
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|
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| Sham TENS Therapy |
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Sham TENS Therapy |
This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Sham TENS Therapy | This group will receive a placebo TENS unit which has been functionally disabled to provide a short initial electrical impulse then cease delivering that impulse. TENS Treatment with functional or disabled unit: TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units. | 0 | 10 | 0 | 10 | 0 | 10 |
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