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Connective Tissue Motion Measure (CTMM1)

S

Stromatec

Status

Completed

Conditions

Low Back Pain

Study type

Observational

Funder types

Industry
NIH

Identifiers

NCT01413997
1R43AT006085-01 (U.S. NIH Grant/Contract)
ctmmp1-R43AT006085

Details and patient eligibility

About

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

Full 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.

Enrollment

39 patients

Sex

All

Ages

21 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

39 participants in 2 patient groups

Chronic Low Back Pain
No Low Back Pain

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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