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Automated Connective Tissue Torque Sensor

NCT ID: NCT01570647

Last Updated: 2013-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Connective Tissue Musculoskeletal Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy controls

No interventions assigned to this group

Chronic low back pain

No interventions assigned to this group

restricted hamstrings

No interventions assigned to this group

systemic scleroderma

No interventions assigned to this group

joint hyperlaxity

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* back pain that has disrupted activity for more than half the days in the past 12 months.


* 90/90 test of more than 20 degrees


* physician diagnosis


* Beighton test score of 7 or higher

Exclusion Criteria

* surgery or scars in thighs or low back
* neurological or major psychiatric disorder
* bleeding disorders
* acute systemic infection
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Stromatec, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Robert Davis

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Davis

Role: PRINCIPAL_INVESTIGATOR

Stromatec, Inc.

Locations

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Stromatec, Inc.

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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R44AT004379

Identifier Type: NIH

Identifier Source: org_study_id

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