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The aim of the study is to evaluate the efficacy of a wearable device using pulse electromagnetic fields on pain intensity reduction, measured by visual analogue score (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), in patients affected by osteoarthritis Secondary aim is the evaluate the effect on knee effusion reduction, when present and to evaluate pain intensity changes corrected by pain threshold measured by pressure algometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active | Active Comparator | Group wearing the active device emitting pulsed electromagnetic fileds |
|
| placebo | Placebo Comparator | Group wearing the device non-emitting pulsed electromagnetic fileds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wearable pulsed electromagnetic fields | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain) | baseline and 4 weeks |
| Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome. | baseline and 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianfilippo Bagnato, Professor | University of Messina | Study Chair |
| Gianfilippo Bagnato, MD | University of Messina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reumatologia, Dipartimento di medicina clinica e sperimentale, Università degli studi di Messina, AOU G. Martino | Messina | Messina | 98100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8478852 | Background | Trock DH, Bollet AJ, Dyer RH Jr, Fielding LP, Miner WK, Markoll R. A double-blind trial of the clinical effects of pulsed electromagnetic fields in osteoarthritis. J Rheumatol. 1993 Mar;20(3):456-60. | |
| 15979009 | Background | Thamsborg G, Florescu A, Oturai P, Fallentin E, Tritsaris K, Dissing S. Treatment of knee osteoarthritis with pulsed electromagnetic fields: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2005 Jul;13(7):575-81. doi: 10.1016/j.joca.2005.02.012. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | emitting group Wearable pulsed electromagnetic fields |
| FG001 | Placebo | non emitting device Wearable pulsed electromagnetic fields |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | emitting group Wearable pulsed electromagnetic fields |
| BG001 | Placebo | non emitting device Wearable pulsed electromagnetic fields |
| 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 Pain Perception Measured on Visual Analog Score (VAS) at Week 4 | visual analogue scale (VAS) is a validated self report instrument assessing self report pain intensity Possible scores ranges:from 0 (no pain) to 100 (the maximum of pain) | Posted | Mean | Standard Deviation | units on a scale | baseline and 4 weeks |
|
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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 | Active | emitting group Wearable pulsed electromagnetic fields |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gianfilippo Bagnato | University of Messina | 00390902212502 | gianbagnato@gmail.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 11900312 | Background | Pipitone N, Scott DL. Magnetic pulse treatment for knee osteoarthritis: a randomised, double-blind, placebo-controlled study. Curr Med Res Opin. 2001;17(3):190-6. doi: 10.1185/0300799039117061. |
| 26705327 | Derived | Bagnato GL, Miceli G, Marino N, Sciortino D, Bagnato GF. Pulsed electromagnetic fields in knee osteoarthritis: a double blind, placebo-controlled, randomized clinical trial. Rheumatology (Oxford). 2016 Apr;55(4):755-62. doi: 10.1093/rheumatology/kev426. Epub 2015 Dec 24. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Primary | Changes From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at Week 4 | Multi-item questionnaire used to assess pain, stiffness, and physical function in patients with knee osteoarthritis. The WOMAC consists of 24 items divided into 3 subscales: Pain (5 items), Stiffness (2 items) and Physical Function (17 items). Score Range: On the Likert Scale version, the scores are summed for items in each subscale, with possible ranges as follows: pain=0-50, stiffness=0-20, physical function=0-170. A total WOMAC score is created by summing the items for all three subscales. A higher score represents a worse outcome. | Posted | Mean | Standard Deviation | units on a scale | baseline and 4 weeks |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Placebo | non emitting device Wearable pulsed electromagnetic fields | 0 | 30 | 0 | 30 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 2-Sided |
| No |
| Superiority or Other |