Connective Tissue Motion Measure
Department of Health and Human Services
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Small Business Information
STROMATEC, INC, 39 TIMBER LN, SOUTH BURLINGTON, VT, 05403
Socially and Economically Disadvantaged:
AbstractDESCRIPTION (provided by applicant): The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) - quantifying the functional behavior of perimuscular connective tissues. The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue. Our Specific Aims are: Aim 1: Develop an integrated, user-friendly, and reliable system for conducting the CTMM. 1) Design and fabricate an automated Needle Stimulus Tool (NST) capable of providing a controlled displacement stimulus to the targeted connective tissue strata. 2) Integrating the NST with an ultrasound transducer in a clinically practical configuration allowing for the measurement and analysis of tissue displacement. 3) Preliminary validation of optimal CTMM procedures and data analysis techniques by performing the measure 1) in-vitro and 2) in-vivo in 5 human subjects. Milestones: Successful completion of Aim I of this work will be indicated by the following: 1. Completion of an operational NST device which is capable of achieving the target linear needle motion requirements. 2. Successful testing of the overall CTMM system demonstrating that the target needling accuracy requirements are achieved in-vitro, and in-vivo. Aim 2: Perform a pilot study of CTMM in human subjects with chronic low back pain (cLBP). Using optimal procedures determined in Aim 1c, we will test 17 subjects with chronic low back pain (cLBP) and 17 control subjects without cLBP. Milestone: Successful completion of Aim I of this work will be indicated by the following: Acquisition of preliminary data allowing sample size calculations for full-scale validation studies of the CTMM which will be conducted during Phase 2. PUBLIC HEALTH RELEVANCE: This project attempts to provide researchers and clinicians with a biomarker - the Connective Tissue Motion Measure - capable of documenting and monitoring the functional status of human connective tissues. Its purpose is to function as an outcome measure to monitor the effect of therapies that may have a therapeutic effect on connective tissue including manual therapies and yoga as well as acupuncture. It is anticipated that this technology will establish the usefulness of connective tissue motion measurements for the diagnosis and clinical management of chronic musculoskeletal pain in general, including low back pain.
* information listed above is at the time of submission.