Connective Tissue Motion Measure 2

This study is currently recruiting participants.
Verified October 2013 by Stromatec, Inc.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Davis, Stromatec, Inc.
ClinicalTrials.gov Identifier:
NCT01784094
First received: January 30, 2013
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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 Intervention
Low Back Pain
Musculoskeletal Pain
Device: StromaGlide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Stromatec, Inc.:

Primary Outcome Measures:
  • Connective Tissue Shear Strain Motion [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to 1 hour ] [ Designated as safety issue: No ]
  • Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to one day ] [ Designated as safety issue: No ]
  • Change in Connective Tissue Shear Strain Motion [ Time Frame: Baseline to one week ] [ Designated as safety issue: No ]

Estimated Enrollment: 222
Study Start Date: January 2013
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Low back pain subjects Device: StromaGlide
No low back pain subjects Device: StromaGlide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784094

Contacts
Contact: Melissa Barry 802-881-0974 mbarry@stromatec.com

Locations
United States, Vermont
Stromatec, Inc Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Robert Davis         
Sponsors and Collaborators
Stromatec, Inc.
  More Information

No publications provided

Responsible Party: Robert Davis, Principal Investigator, Stromatec, Inc.
ClinicalTrials.gov Identifier: NCT01784094     History of Changes
Other Study ID Numbers: 2R44AT006085
Study First Received: January 30, 2013
Last Updated: October 8, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014