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Automated Connective Tissue Torque Sensor (StromaTorque)

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ClinicalTrials.gov Identifier: NCT01570647
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : October 9, 2013
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Robert Davis, Stromatec, Inc.

Brief Summary:
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 or disease
Connective Tissue Musculoskeletal Pain

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
Actual Enrollment : 165 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Automated Connective Tissue Torque Sensor
Study Start Date : February 2012
Primary Completion Date : January 2013
Study Completion Date : January 2013

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

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

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

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

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

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

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 Posted: April 4, 2012    Key Record Dates
Last Update Posted: October 9, 2013
Last Verified: October 2013

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