Connective Tissue Motion Measure (CTMM1)

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

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

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• United States
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Stromatec, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Community Sample

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Chronic Low Back Pain
No Low Back Pain

Collaborators and Investigators

• Sponsor: Stromatec, Inc.
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: August 9, 2011
• First Posted (Estimate): August 10, 2011

Study Record Updates

• Last Update Posted (Estimate): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 9, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: ctmmp1-R43AT006085; 1R43AT006085-01 (U.S. NIH Grant/Contract)