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The purpose of this study is to investigate whether pulsed electromagnetic energy field (PEMF) therapy is effective in the treatment of persistent pain following total knee arthroplasty (TKA)
This is a multi-site randomized, double-blinded, parallel-group prospective pilot study of the analgesic effectiveness of twice-daily PEMF therapy in the treatment of persistent post-operative pain following Total Knee Arthroplasty (TKA). Following a run-in period of 10 days to collect their baseline pain intensity scores, activity levels and opioid consumption, eligible subjects will be randomized in a 2:1 ratio to receive therapy with an active PEMF device or an identical inactive Sham device. Subjects will self-treat twice daily for 60 days while at home. Subjects will collect electronic patient-reported outcome (ePRO) data each morning through Day 75. Subjects will be evaluated at the research center for Interim Visits at Day 21, Day 41, Day 61 and Day 75 for assessment of safety, concomitant medications, range of motion, weight, peripheral edema, and quality of life outcomes. At Day 90, Day 150, and Day 240 assessment of pain intensity, opioid consumption, safety, review of concomitant medications and interval history will be performed, with data collected via telephone contact.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulsed Electromagnetic Field Device | Active Comparator | Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. |
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| Sham Pulsed Electromagnetic Field Device | Sham Comparator | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed Electromagnetic Field Device (Provant) | Device | The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity | Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents "Worst Pain Imaginable". | Assessed at Day 60 as compared to Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Pulsed Electromagnetic Field Device | Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Sham Pulsed Electromagnetic Field Device | Device | The Sham device will be identical in appearance, physical characteristics and operation to the Active device. |
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| Mean change from Day 0 to Day 75 |
| Beck Depression Inventory (BDI) | Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score. BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61. | Responders at Day 75 (compared to baseline) |
| Patient Global Impression of Change (PGIC) | Responder Analysis at Day 75 (patents stating they are "Improved" to "Much Improved") using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved. | Day 75 |
| Analgesic Consumption | Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed. | Day 56 to Day 60 (compared to baseline) |
| Change From Baseline in Range of Motion (ROM) | The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer. | Days 0 (Baseline) and Day 75 |
| Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm) | The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure. | Day 75 |
| Change in Pain Intensity - Average Pain Intensity | Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). | At Days 75, 90, 150 and 240, as compared to Baseline |
| Phoenix |
| Arizona |
| 85018 |
| United States |
| Phoenix | Arizona | 85023 | United States |
| El Cajon | California | 92020 | United States |
| Lone Tree | Colorado | 80124 | United States |
| Bradenton | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Las Vegas | Nevada | 89128 | United States |
| New York | New York | 10022 | United States |
| Raleigh | North Carolina | United States |
| Spartanburg | South Carolina | 29303 | United States |
| St. George | Utah | 84790 | United States |
| Danville | Virginia | United States |
| Spokane | Washington | 99218 | United States |
| FG001 | Sham Pulsed Electromagnetic Field Device | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Pulsed Electromagnetic Field Device | Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment. |
| BG001 | Sham Pulsed Electromagnetic Field Device | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. |
| BG002 | 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, Continuous | Mean | Full Range | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Pain Catastrophizing Score | The Pain Catastrophizing Scale (PCS) is a validated assessment tool for the extent to which patients catastrophize their pain. The scale asks 13 questions about types of thoughts and feelings associated with pain. Responses are based upon a 5-point scale ranging from 0 to 4, where 0=not at all and 4=all the time. A total score is calculated ranging from 0 to 52. Higher scores represent a higher catastrophization of pain. The PCS will be administered at the research center during the Screening Visit, and scored by research personnel. | Mean | Full Range | units on a scale |
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| BMI | Mean | Full Range | kg/m^2 |
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| PainDETECT Questionnaire | PainDETECT Questionniare (PD-q): a self-reported assessment designed to identify the presence of a neuropathic pain component in subjects with pain. Subjects assessed current pain, strongest pain, average pain, areas of pain, course of pain and symptoms (such as burning, tingling, numbness and sensitivity). The scale ranged from 0 to 38 defined as follows: score 0-12 = neuropathic pain component unlikely; 13-18 = result is ambiguous; 19-38 = neuropathic pain component is likely. | Mean | Full Range | units on a scale |
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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 | Change in Pain Intensity | Percent change from Baseline in Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). A score of 0 represents 'No Pain' while a score of 10 represents "Worst Pain Imaginable". | Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 60 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 60 assessment. Subjects without a Day 60 assessment were left out of the analysis. | Posted | Mean | Standard Deviation | Units on a scale | Assessed at Day 60 as compared to Baseline |
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| Secondary | Mean Change From Baseline in Knee Injury and Osteoarthritis Outcome Score (KOOS) | Knee Injury and Osteoarthritis Outcome Score (KOOS): a validated knee-specific instrument that measures the short-term and long-term symptoms and function associated with knee injury. KOOS consists of 5 categories: pain, other symptoms, function in daily living, function in sport and recreation, and knee related quality of life. Patients are asked to answer questions relating to these categories and respond with Never/None/Not at all, Rarely/Monthly/Mild, Sometimes/Moderate/Weekly, Often/Severe/Daily or Always/Extreme/Totally/Constantly. Each response gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. The mean change in score from baseline to Day 75 is displayed below. | Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis. | Posted | Mean | Standard Deviation | units on a scale | Mean change from Day 0 to Day 75 |
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| Secondary | Beck Depression Inventory (BDI) | Responders: Defined as subjects with a 5-point decrease in Beck Depression Inventory (BDI) score. BDI is a validated self-reported assessment of current symptoms of depressive disorders, with total scores ranging from 0 to 63. The BDI scale consists of 21 groups of statements with each score/response ranging from 0 to 3. Higher scores represent greater depression. The BDI was conducted at baseline prior to study device treatments and again at Day 61. | Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis. | Posted | Count of Participants | Participants | Responders at Day 75 (compared to baseline) |
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| Secondary | Patient Global Impression of Change (PGIC) | Responder Analysis at Day 75 (patents stating they are "Improved" to "Much Improved") using the Patient Global Impression of Change (PGIC). PGIC is a 7-point validated categorical scale of overall change in status since initiation of treatment with the study device. PGIC allows subjects to integrate into one overall evaluation the different aspects of their response to treatment, including pain reduction, improvement in functioning and side effects. Subjects select one of the following response at the end of treatment: Very Much Worse, Much Worse, Minimally Worse, No Change, Minimally Improved, Improved, or Much Improved. | Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis. | Posted | Count of Participants | Participants | Day 75 |
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| Secondary | Analgesic Consumption | Consumption of opioid analgesics in the preceding 24 hours will be self-reported by the subject in the ePRO diary on a daily basis during the 10-day run-in period, treatment period and through Day 75. The results below display the difference in opioid analgesic consumption from baseline to Day 56-60. Subject recorded the number of tablets consumed. | Number of Participants Analyzed differs from numbers above due to the number of subjects reporting opioid analgesic consumption in their ePRO diary. | Posted | Mean | Standard Deviation | Number of tablets taken | Day 56 to Day 60 (compared to baseline) |
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| Secondary | Change From Baseline in Range of Motion (ROM) | The degree of passive (movement of the knee with the aid of study personnel) and active (subject moving the knee) knee flexion and extension tolerated by the subject will be recorded. ROM will be assessed in the sitting position using a goniometer. | Posted | Mean | Standard Deviation | degrees of motion | Days 0 (Baseline) and Day 75 |
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| Secondary | Change From Baseline in Peripheral Edema - Maximal Circumference of Calf (cm) | The maximal circumference of the calf and circumference of the thigh at 10 cm and 15 cm cranial to the superior pole of the patella of the index knee will be measured using a tape measure. | Discrepancy in Numbers of Participants Analyzed is due to the number of subjects completing the Day 75 assessment. Not all subjects that were enrolled and had baseline data captured completed the Day 75 assessment. Subjects without a Day 75 assessment were left out of the analysis. | Posted | Mean | Standard Deviation | cm | Day 75 |
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| Secondary | Change in Pain Intensity - Average Pain Intensity | Pain Intensity (PI): a validated 11-point Numeric Pain Rating Scale (NPRS) with scores (0-10) collected as patient-reported outcomes on an electronic diary (ePRO). | Data were not collected. | Posted | At Days 75, 90, 150 and 240, as compared to 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 | Pulsed Electromagnetic Field Device | Pulsed Electromagnetic Field therapy device; self-administered at home twice daily for 30 minutes. Pulsed Electromagnetic Field Device (Provant): The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment. | 0 | 24 | 6 | 24 | ||
| EG001 | Sham Pulsed Electromagnetic Field Device | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. | 0 | 11 | 4 | 11 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Chest Pain | General disorders | Systematic Assessment |
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| Arrhythemia | Cardiac disorders | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | Systematic Assessment |
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| Burns second degree | Injury, poisoning and procedural complications | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Synovitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Publication Rights. Independent analysis and/or publication of data generated is not permitted without the prior written consent of the sponsor. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Vander Ploeg | Regenesis Biomedical | 602-4287041 | Heather.VanderPloeg@regenesisbio.com |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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| OG001 | Sham Pulsed Electromagnetic Field Device | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. |
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| OG001 | Sham Pulsed Electromagnetic Field Device | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. |
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| OG001 | Sham Pulsed Electromagnetic Field Device | Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes. Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device. |
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Inactive Pulsed Electromagnetic Field Therapy device; self-administered at home twice daily for 30 minutes.
Sham Pulsed Electromagnetic Field Device: The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
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