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
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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 METHODS

Efficacy analysis will be according to the intent to treat (ITT) principle by last observation carried forward (LOCF).

Intent to Treat: Subjects will be included in the ITT analysis if they were randomized to study procedure group, had successfully completed the Baseline Standardization Phase and had received at least one study procedure administration (1 out of 8 procedures).

Last observation carried forward: Missing data will be handled by carrying forward the last observation.

STATISTICAL ANALYSIS

The primary analysis of efficacy will be through parametric analysis of variance (ANOVA) model.

The parametric ANOVA model will be applied with the mean change from baseline to endpoint in 3-recording average daily pain rating for the study hip as the dependent variable and procedure group as the independent variable of interest. A two-tailed significance level of 5% will be considered to be statistically significant.

Analysis by paired-samples t-test will also be conducted.

Secondary Measures Analysis
The secondary measures are continuous variables and will be analyzed through parametric analysis using ANOVA. A two-way significance level of 5% will be considered to be statistically significant.

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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.