Automated Connective Tissue Torque Sensor (StromaTorque)
This study is currently recruiting participants.
Verified January 2013 by Stromatec, Inc.
Information provided by (Responsible Party):
Robert Davis, Stromatec, Inc.
First received: April 1, 2012
Last updated: January 30, 2013
Last verified: January 2013
The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||Automated Connective Tissue Torque Sensor
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 ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||January 2013 (Final data collection date for primary outcome measure)
Chronic low back pain
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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:
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570647
|Burlington, Vermont, United States, 05401 |
No publications provided
ClinicalTrials.gov processed this record on May 23, 2013
||Robert Davis, Principle Investigator, Stromatec, Inc.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 1, 2012
||January 30, 2013
||United States: Federal Government
United States: Institutional Review Board