Connective Tissue Motion Measure

NCT ID: NCT01413997

Last Updated: 2011-08-10

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

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-07-31

Brief Summary

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The goal of this project is to develop a biomarker - the Connective Tissue Motion Measure (CTMM) -quantifying the functional behavior of perimuscular connective tissues.

Detailed Description

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The differential motion between specific connective tissue strata will be measured during tissue displacement (linear oscillation) initiated by a computer-controlled needle stimulus tool (NST). The CTMM will be suitable as an outcome measure for mechanistic and clinical studies of CAM interventions. The CTMM also will potentially serve as a clinical diagnostic and treatment-monitoring tool for manual therapists, acupuncturists, and CAM clinicians interested in assessing the functional status of a patient's connective tissue.

Conditions

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Low Back Pain

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Chronic Low Back Pain

No interventions assigned to this group

No Low Back Pain

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* history of recurrent or chronic LBP for a minimum of 12 months
* ability to stand and walk without assistance
* ability to understand and read English
* ability to understand and sign a consent form


* no history of low back pain or any other chronic pain that has limited activities of daily living or work
* a numerical current pain index of less than 0.5.

Exclusion Criteria

* previous severe back or low extremity injury or surgery
* major structural spinal deformity (scoliosis, kyphosis, stenosis)
* ankylosing spondylitis or rheumatoid arthritis
* neurological deficit (weakness and/or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica)
* neurological or major psychiatric disorder
* bleeding disorders
* corticosteroid or anticoagulant medication
* pregnancy
* worker's compensation or disability case
* in litigation for the LBP problem
* acute systemic infection
* BMI less than 21 or greater than 35
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 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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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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1R43AT006085-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ctmmp1-R43AT006085

Identifier Type: -

Identifier Source: org_study_id

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