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OpenTrials
Completed

NCT Number: NCT01784094

Connective Tissue Motion Measure 2

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stromatec, Inc

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

StromaGlide

Device

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Stromatec, Inc.

Industry

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 5, 2013
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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