Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-27 @ 10:00 AM
Study NCT ID:
NCT00487266
Status:
COMPLETED
Last Update Posted:
2013-11-05
First Post:
2007-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain
Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Organization:
Study Overview
Official Title:
Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 07-025 | OTHER | CHRMS | View |