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Connective Tissue Motion Measure 2

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ClinicalTrials.gov Identifier: NCT01784094
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Robert Davis, Stromatec, Inc.

January 30, 2013
February 5, 2013
December 30, 2014
January 2013
October 2014   (Final data collection date for primary outcome measure)
  • Connective Tissue Shear Strain Motion [ Time Frame: Baseline ]
  • Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to 1 hour ]
  • Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to one day ]
  • Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to one week ]
Same as current
Complete list of historical versions of study NCT01784094 on ClinicalTrials.gov Archive Site
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Connective Tissue Motion Measure 2
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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.
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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample
Community sample
  • Low Back Pain
  • Musculoskeletal Pain
Device: StromaGlide
  • Low back pain subjects
    Subjects with chronic or recurrent low back pain
    Intervention: Device: StromaGlide
  • No low back pain subjects
    Subjects who are generally healthy with no low back pain
    Intervention: Device: StromaGlide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
222
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria for all subjects:

  • able to stand and walk without assistance
  • able to read and understand English
  • able to understand and sign a consent form

Inclusion Criteria for low back pain subjects:

  • history of recurrent or chronic low back pain

Inclusion criteria for no-low back pain subjects:

  • 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

Exclusion Criteria for all subjects:

  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01784094
2R44AT006085( U.S. NIH Grant/Contract )
Yes
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Robert Davis, Stromatec, Inc.
Stromatec, Inc.
National Center for Complementary and Integrative Health (NCCIH)
Not Provided
Stromatec, Inc.
December 2014