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Connective Tissue Motion Measure 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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.

Tracking Information
First Submitted Date January 30, 2013
First Posted Date February 5, 2013
Last Update Posted Date December 30, 2014
Study Start Date January 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 1, 2013)
  • 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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01784094 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Connective Tissue Motion Measure 2
Official Title Not Provided
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Community sample
Condition
  • Low Back Pain
  • Musculoskeletal Pain
Intervention Device: StromaGlide
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 29, 2014)
195
Original Estimated Enrollment
 (submitted: February 1, 2013)
222
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01784094
Other Study ID Numbers 2R44AT006085( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Robert Davis, Stromatec, Inc.
Study Sponsor Stromatec, Inc.
Collaborators National Center for Complementary and Integrative Health (NCCIH)
Investigators Not Provided
PRS Account Stromatec, Inc.
Verification Date December 2014