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Automated Connective Tissue Torque Sensor (StromaTorque)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01570647
First Posted: April 4, 2012
Last Update Posted: October 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Robert Davis, Stromatec, Inc.
  Purpose
The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.

Condition
Connective Tissue Musculoskeletal Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Automated Connective Tissue Torque Sensor

Further study details as provided by Robert Davis, Stromatec, Inc.:

Primary Outcome Measures:
  • Number of needle revolutions to achieve threshold torque [ Time Frame: Time zero, 30 minutes and one week ]

Enrollment: 165
Study Start Date: February 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy controls
Chronic low back pain
restricted hamstrings
systemic scleroderma
joint hyperlaxity

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
community sample
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01570647


Locations
United States, Vermont
Stromatec, Inc.
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Stromatec, Inc.
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Robert Davis Stromatec, Inc.
  More Information

Responsible Party: Robert Davis, Principal Investigator, Stromatec, Inc.
ClinicalTrials.gov Identifier: NCT01570647     History of Changes
Other Study ID Numbers: R44AT004379 ( U.S. NIH Grant/Contract )
First Submitted: April 1, 2012
First Posted: April 4, 2012
Last Update Posted: October 9, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Musculoskeletal Pain
Muscular Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms