Connective Tissue Motion Measure 2

Low Back Pain Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01784094
• Other study ID #: 2R44AT006085
• Status: Completed
• Phase: N/A
• First received: January 30, 2013
• Last updated: December 29, 2014
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Stromatec, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Low Back Pain
• Musculoskeletal Pain

Intervention

Device:
• StromaGlide

Locations

Country	Name	City	State
United States	Stromatec, Inc	Burlington	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
Stromatec, Inc.	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Connective Tissue Shear Strain Motion		Baseline	No
Primary	Change in Connective Tissue Shear Strain Motion		Baseline to 1 hour	No
Primary	Change in Connective Tissue Shear Strain Motion		Baseline to one day	No
Primary	Change in Connective Tissue Shear Strain Motion		Baseline to one week	No