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Automated Connective Tissue Torque Sensor (StromaTorque)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Davis, Stromatec, Inc.
ClinicalTrials.gov Identifier:
NCT01570647
First received: April 1, 2012
Last updated: October 8, 2013
Last verified: October 2013
  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 Stromatec, Inc.:

Primary Outcome Measures:
  • Number of needle revolutions to achieve threshold torque [ Time Frame: Time zero, 30 minutes and one week ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570647

Locations
United States, Vermont
Stromatec, Inc.
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Stromatec, Inc.
Investigators
Principal Investigator: Robert Davis Stromatec, Inc.
  More Information

No publications provided

Responsible Party: Robert Davis, Principal Investigator, Stromatec, Inc.
ClinicalTrials.gov Identifier: NCT01570647     History of Changes
Other Study ID Numbers: R44AT004379
Study First Received: April 1, 2012
Last Updated: October 8, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 23, 2014