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Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain

NCT00487266 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2013-11-05

No results posted yet for this study

Summary

The goal of this proposal is to test the overall hypothesis that subjects with chronic or recurrent low back pain have an abnormal soft tissue response to acupuncture needling, and that this altered response is associated with abnormal perimuscular connective tissue structure and biomechanics. We will also test whether or not altered needling responses in low back pain are generalized, or localized to specific locations as predicted by traditional acupuncture theory. This proposal is part of a series of projects investigating the role of connective tissue in the mechanism of acupuncture and, in addition, constitutes a first step in examining the role of connective tissue in low back pain. Acupuncturists describe qualitatively different needling responses at locations believed to be "involved" in the patient's disease process. Although assessing abnormalities in the needling response is a fundamental aspect of acupuncture therapy, what constitutes a normal vs. abnormal needling response has never been studied quantitatively. Thus the nature of tissue changes underlying these phenomena remains unknown. We have recently developed a new in vivo technique based on ultrasound elastography that allows visualization and quantification of tissue displacement and strain patterns developed in tissues during needle manipulation in humans \[1\] (Appendix A). In this proposal, we will use ultrasound elastography, ultrasound image analysis and biomechanical modeling to perform 1) quantitative measurement of soft tissue behavior during needling and 2) detailed analysis of perimuscular connective tissue structure and biomechanics in human subjects with and without low back pain.

Conditions

  • Low Back Pain

Interventions

OTHER

Acupuncture

Acupuncture of low back and legs.

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Helene M. Langevin, M.D. · University of Vermont

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2009-09-30
Completion
2010-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00487266 on ClinicalTrials.gov