Osteoarthritis Clinical Study Information - Pico-Tesla Magnetic Therapies, LLC

		Osteoarthritis Clinical Study Information The Resonator™ device uses electro-magnetic stimulation in order to relieve symptoms of a disorder or disease. Overview Device User Interface Safety and Risks FDA Clearance Overview The Resonator™ Device Compared to Other Magnetic Devices and Parkinson’s Disease Therapies The Device Versus MRI (Magnetic Resonance Imaging) The Device Versus TMS and rTMS The Device Versus Other Parkinson’s Disease Therapies Overview Jacobson Resonance™

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Study Information
Contact Information
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Purpose & Overview
Worldwide Regulatory Status

Device Information
Device Information
Device Details
Signal Generation
Helmholtz Coils
Determination of Device Safety
Institutional Review Board (IRB)

Study Details
Study Indication
Etiology
Symptoms
Diagnosis
Treatments
Study Treatment Modality: EM Stimulation
Theory of Mechanism of Operation (Part 1)
Theory of Mechanism of Operation (Part 2)
Theory of Mechanism of Operation (Part 3)
EM Stimulation Therapy Rationale
rTMS / TMS
Research (Part 1)
Research (Part 2)
Supporting Materials (Part 1)
Supporting Materials (Part 2)
Supporting Materials (Part 3)
Supporting Materials (Part 4)

Study Design
Procedure Groups
Double-Blind Design
Subjects
Study Test Battery (Part 1)
Study Test Battery (Part 2)
Study Test Battery (Part 3)
Study Test Battery (Part 4)
Pre-Procedure Activities
Inclusion Criteria
Exclusion Criteria
Baseline Assessment

Study Procedures
Standardization Phase
Study Procedure Administration Protocol
During-Procedure Activities
Pre- and Post-Procedure Administration Phases
Post-Procedure Activities
Post-Procedure Activities (Days 15-42)
Statistical Analysis Plan
Secondary Efficacy Outcome
Statistical Methods & Analysis
Safety Analysis
Early Termination Visit
Safety and Confidentiality Issues

STATISTICAL ANALYSIS PLAN

The aim of this study is to determine if the procedure effect of the Resonator™ device for the active procedure group is greater than that for the placebo group.

The study will be considered a success if, using the Intent-To-Treat (ITT) Last Observation Carried Forward (LOCF) analysis, the primary endpoint is statistically significant at the 0.05 level.

PRIMARY EFFICACY OUTCOME MEASURE: The primary efficacy outcome measure in this pilot study is the mean change from baseline to study endpoint in the 3-recording average of the subject‘s Daily Pain Rating on the 0-100 VAS for the study hip recorded each morning upon waking and prior to consuming any pain medication for the day.

The Baseline Pain Rating will be calculated as the average of the 3 pain ratings recorded by the subject during the 3-day Baseline Standardization Phase. The study Endpoint Pain Rating will be calculated as the average of the 3 study hip pain ratings recorded by the subject on Days 15, 16 and 17 of the post-procedure phase. The mean change will be calculated as the difference in mean group score from baseline to study endpoint.

As this is an observational pilot study, there are no pre-established individual subject or study success criteria; rather, it is a goal of this study that the results be used to assist in developing individual subject and study success criteria for a potential subsequent full-scale clinical study.

Evaluation Time Point
The primary evaluation time point for change will be following completion of the two-week study procedure administration phase (study endpoint).

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The Resonator™ device is an Investigational Device limited by Federal (or United States)
law to investigational use. The Resonator™ device is not for sale, nor is the Magneceutical^®
Therapy generally available outside of Investigational Review Board (IRB) approved clinical studies.