Automated Connective Tissue Torque Sensor

Musculoskeletal Pain Clinical Trial

— StromaTorque  

Official title:

Automated Connective Tissue Torque Sensor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01570647
• Other study ID #: R44AT004379
• Status: Completed
• Phase: N/A
• First received: April 1, 2012
• Last updated: October 8, 2013
• Start date: February 2012
• Est. completion date: January 2013

Study information

• Verified date: October 2013
• Source: Stromatec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Connective Tissue
• Musculoskeletal Pain

Locations

Country	Name	City	State
United States	Stromatec, Inc.	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Stromatec, Inc.	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of needle revolutions to achieve threshold torque		Time zero, 30 minutes and one week	No