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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:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Low Back Pain Musculoskeletal Pain Device: StromaGlide

Study Design

Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : January 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Low back pain subjects
Subjects with chronic or recurrent low back pain
Device: StromaGlide
No low back pain subjects
Subjects who are generally healthy with no low back pain
Device: StromaGlide


Outcome Measures

Primary Outcome Measures :
  1. Connective Tissue Shear Strain Motion [ Time Frame: Baseline ]
  2. Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to 1 hour ]
  3. Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to one day ]
  4. Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to one week ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01784094


Locations
United States, Vermont
Stromatec, Inc
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Stromatec, Inc.
National Center for Complementary and Integrative Health (NCCIH)
More Information

Responsible Party: Robert Davis, Principal Investigator, Stromatec, Inc.
ClinicalTrials.gov Identifier: NCT01784094     History of Changes
Other Study ID Numbers: 2R44AT006085 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2013    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases