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Connective Tissue Motion Measure (CTMM1)

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ClinicalTrials.gov Identifier: NCT01413997
Recruitment Status : Completed
First Posted : August 10, 2011
Last Update Posted : August 10, 2011
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by:
Stromatec, Inc.

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

Condition or disease
Low Back Pain

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 39 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Feasibility Study of Connective Tissue Motion Measure - a Biomarker for Perimuscular Connective Tissue Pathology.
Study Start Date : April 2011
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort
Chronic Low Back Pain
No Low Back Pain




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community Sample
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413997


Locations
United States, Vermont
Stromatec, Inc.
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Stromatec, Inc.
National Center for Complementary and Integrative Health (NCCIH)

Responsible Party: Robert Davis, CEO, Stromatec, Inc.
ClinicalTrials.gov Identifier: NCT01413997     History of Changes
Other Study ID Numbers: ctmmp1-R43AT006085
1R43AT006085-01 ( U.S. NIH Grant/Contract )
First Posted: August 10, 2011    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms