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OpenTrials
Completed

NCT Number: NCT01570647

Automated Connective Tissue Torque Sensor

The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stromatec, Inc.

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of needle revolutions to achieve threshold torque

    Time frame: Time zero, 30 minutes and one week

Sponsors and collaborators

Lead sponsor

Stromatec, Inc.

Industry

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Acronym: StromaTorque

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 4, 2012
Registry last updated
Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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