Connective Tissue Motion Measure (CTMM1)

This study has been completed.
Sponsor:
Collaborator:
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:


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.
  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 April 14, 2014