Status:
COMPLETED
Connective Tissue Motion Measure
Lead Sponsor:
Stromatec, Inc.
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Low Back Pain
Eligibility:
All Genders
21-70 years
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 CT...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01413997
Start Date
April 1 2011
End Date
July 1 2011
Last Update
August 10 2011
Active Locations (1)
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1
Stromatec, Inc.
Burlington, Vermont, United States, 05401