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OpenTrials
Completed

NCT Number: NCT01413997

Connective Tissue Motion Measure

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

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stromatec, Inc.

Burlington, Vermont, 05401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for LBP subjects:

  • 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

Inclusion criteria

for No-LBP subjects:

  • 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

for all subjects:

  • 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

Sponsors and collaborators

Lead sponsor

Stromatec, Inc.

Industry

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Feasibility Study of Connective Tissue Motion Measure - a Biomarker for Perimuscular Connective Tissue Pathology.

Acronym: CTMM1

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2011
Registry last updated
Aug 10, 2011

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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