Automated Connective Tissue Torque Sensor (StromaTorque)

October 8, 2013 updated by: Robert Davis, Stromatec, Inc.
The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.

Study Overview

Status

Completed

Conditions

Detailed Description

Chronic musculoskeletal pain is a source of considerable disability, work absenteeism and health care costs. A major obstacle to the treatment of these conditions is the lack of methods to objectively assess connective tissues and measure the effect of treatments. Needle torque test technology under development in this project will potentially enable objective measurement of connective tissue abnormalities associated with musculoskeletal pain and dysfunction. This could help evaluate the efficacy of various treatments and enhance the objective monitoring of patient progress in clinical practice.

Study Type

Observational

Enrollment (Actual)

165

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Stromatec, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

Inclusion Criteria for chronic low back pain subjects:

  • back pain that has disrupted activity for more than half the days in the past 12 months.

Inclusion Criteria for restricted hamstring subjects:

  • 90/90 test of more than 20 degrees

Inclusion Criteria for systemic scleroderma subjects:

  • physician diagnosis

Inclusion criteria for joint hyperlaxity subjects:

  • Beighton test score of 7 or higher

Exclusion Criteria for all subjects:

  • surgery or scars in thighs or low back
  • neurological or major psychiatric disorder
  • bleeding disorders
  • acute systemic infection
  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Healthy controls
Chronic low back pain
restricted hamstrings
systemic scleroderma
joint hyperlaxity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of needle revolutions to achieve threshold torque
Time Frame: Time zero, 30 minutes and one week
Time zero, 30 minutes and one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stromatec, Inc.

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Robert Davis, Stromatec, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 1, 2012

First Submitted That Met QC Criteria

April 3, 2012

First Posted (Estimate)

April 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 9, 2013

Last Update Submitted That Met QC Criteria

October 8, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R44AT004379 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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