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Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain

Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00487266
Enrollment
180
Registered
2007-06-18
Start date
2006-09-30
Completion date
2010-08-31
Last updated
2013-11-05

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

Conditions

Low Back Pain

Keywords

Acupuncture, Torque, Force Decay

Brief 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.

Detailed description

See Brief Summary

Interventions

OTHERAcupuncture

Acupuncture of low back and legs.

Sponsors

National Center for Complementary and Integrative Health (NCCIH)
Lead SponsorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria for LBP subjects will be the following: 1. History of recurrent or chronic LBP as defined by Von Korff {Von Korff, 1992 #6777} {Von Korff, 1994 #6816} for a minimum of 12 months 2. Able to stand and walk without assistance 3. Able to understand and read English 4. Able to understand and sign a consent form. Subjects' LBP will be further defined as being recurrent or chronic LPB based on the number of days with symptoms over a period of one year. * Recurrent LBP will be defined as back pain present on less than ½ the days in a 12-month period, occurring in multiple episodes over a year. * Chronic LBP will be defined as back pain present on at least ½ the days in a 12-month period in a single or multiple episodes. Inclusion criteria for No-LBP subjects: Criteria for selecting No-LBP subjects will be: 1. No history of low back pain or any other chronic pain that has limited activities of daily living or work 2. A numerical current pain index of less than 0.5. No-LBP subjects will be matched for age, sex and subcutaneous tissue thickness with LBP subjects.

Exclusion criteria

For all subjects,

Design outcomes

Primary

MeasureTime frame
Primary outcome measures will be peak torque during needle rotation (Torque); force decay time constant during needle oscillation (ForceDecay) and tissue displacement (Displacement) in Subcutaneous, Perimuscular and Muscle zones during needle oscillation3 years

Countries

United States

Outcome results

None listed

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