Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain

Low Back Pain Clinical Trial

Official title:

Soft Tissue Biomechanical Behavior During Acupuncture in Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00487266
• Other study ID #: R01AT003479-01A1
• Secondary ID: 07-025
• Status: Completed
• Phase: N/A
• First received: June 14, 2007
• Last updated: November 4, 2013
• Start date: September 2006
• Est. completion date: August 2010

Study information

• Verified date: November 2013
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

See Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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, exclusion criteria determined by history and physical exam will be the following:

1. Previous severe back or low extremity injury or surgery

2. Major structural spinal deformity (scoliosis, kyphosis, stenosis)

3. Ankylosing spondylitis or rheumatoid arthritis

4. Spondyloarthropathy or disc herniation

5. Spinal fracture, tumor or infection

6. Neurological deficit (weakness and/or sensory loss, decreased deep tendon reflexes suggesting nerve root compression, but not subjective symptoms of nerve root irritation (sciatica)

7. Neurological or major psychiatric disorder

8. Bleeding disorders

9. Corticosteroid or anticoagulant medication

10. Pregnancy

11. worker's compensation or disability case

12. In litigation for the LBP problem

13. Acute systemic infection

14. BMI greater than 23% or less than 32%. Preliminary testing has shown that individuals with a BMI of less than 23% have an insufficient depth of the subcutaneous and fat zone (Zone P) for data processing. Individuals with a BMI greater than 32% have a subcutaneous and fat zone (Zone P) thickness which is greater than the acupuncture needle length, which will not allow penetration of the muscle layer (Zone M).

15. Subjects will need to not take non-steroidal anti-inflammatory (NSAIDs) medication for 3 days prior to testing in order to avoid the potentially confounding acute effects of NSAIDs on connective tissue.

16. In addition, LBP subjects will be excluded if they are in an acute flare-up of LBP. Flare-up will be defined as short period (less than one week) when pain is markedly more severe than usual for that individual (at least 5 points above baseline on pain index).

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Acupuncture
Acupuncture of low back and legs.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
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	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 oscillation		3 years	No