Connective Tissue Motion Measure (CTMM1)

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