Connective Tissue Motion Measure 2
1 other identifier
observational
195
1 country
1
Brief Summary
This study aims to compare the Connective Tissue Motion Measure (CTMM) in low back pain and no-low back pain subjects, evaluate the reliability of the CTMM, and examine the correlation of CTMM with low back pain symptoms, disability, and functional measures. The investigators hypothesize that CTMM will be reduced, on average, in low back pain subjects, that CTMM will be reliable with an intra-class correlation greater than 0.8, and CTMM will negatively correlate with low back pain symptoms, disability and functional measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 30, 2013
CompletedFirst Posted
Study publicly available on registry
February 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedDecember 30, 2014
December 1, 2014
1.7 years
January 30, 2013
December 29, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
Connective Tissue Shear Strain Motion
Baseline
Change in Connective Tissue Shear Strain Motion
Baseline to 1 hour
Change in Connective Tissue Shear Strain Motion
Baseline to one day
Change in Connective Tissue Shear Strain Motion
Baseline to one week
Study Arms (2)
Low back pain subjects
Subjects with chronic or recurrent low back pain
No low back pain subjects
Subjects who are generally healthy with no low back pain
Interventions
Eligibility Criteria
Community sample
You may qualify if:
- able to stand and walk without assistance
- able to read and understand English
- able to understand and sign a consent form
- history of recurrent or chronic low back pain
- no history of low back pain or other chronic pain that has limited activities of daily living or work
- numerical chronic pain index of less than 0.5
You may not qualify if:
- previous severe back or lower extremity injury or surgery
- major structural spinal deformity (scoliosis, kyphosis, stenosis)
- ankylosing spondylitis or rheumatoid arthritis
- neurological deficit (weakness or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica))
- radicular pain
- neurological or major psychiatric disorder
- bleeding disorders
- corticosteroid or anticoagulant medication
- substance abuse
- pregnancy
- active worker's compensation or disability case
- in litigation for a low back pain problem
- acute systemic infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stromatec, Inc
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 30, 2013
First Posted
February 5, 2013
Study Start
January 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
December 30, 2014
Record last verified: 2014-12