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Connective Tissue Motion Measure (CTMM1)

This study has been completed.
Sponsor:
Collaborator:
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:
Stromatec, Inc.
ClinicalTrials.gov Identifier:
NCT01413997
First received: August 9, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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
Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Feasibility Study of Connective Tissue Motion Measure - a Biomarker for Perimuscular Connective Tissue Pathology.

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Stromatec, Inc.:

Enrollment: 39
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic Low Back Pain
No 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.

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01413997

Locations
United States, Vermont
Stromatec, Inc.
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Stromatec, Inc.
National Center for Complementary and Alternative Medicine (NCCAM)
  More Information

No publications provided

Responsible Party: Robert Davis, CEO, Stromatec, Inc.
ClinicalTrials.gov Identifier: NCT01413997     History of Changes
Other Study ID Numbers: ctmmp1-R43AT006085, 1R43AT006085-01
Study First Received: August 9, 2011
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013