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Connective Tissue Motion Measure 2

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01784094
Enrollment
195
Registered
2013-02-05
Start date
2013-01-31
Completion date
2014-10-31
Last updated
2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain, Musculoskeletal Pain

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.

Interventions

DEVICEStromaGlide

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
CollaboratorNIH
Stromatec, Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Connective Tissue Shear Strain MotionBaseline
Change in Connective Tissue Shear Strain MotionBaseline to 1 hour

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026