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Connective Tissue Motion Measure

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01413997
Acronym
CTMM1
Enrollment
39
Registered
2011-08-10
Start date
2011-04-30
Completion date
2011-07-31
Last updated
2011-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

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.

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.

Interventions

None listed

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Stromatec, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026