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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03483714
Other study ID # LSM
Secondary ID
Status Completed
Phase
First received March 11, 2018
Last updated March 28, 2018
Start date February 1, 2011
Est. completion date November 5, 2015

Study information

Verified date March 2018
Source University of Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To characterize muscle activity through electromyography (EMG) of the lumbar spine during high velocity, low amplitude (HVLA) spinal manipulation according to parameters of practitioner contact (location, applied force) in healthy participants and two categories of low back pain participants.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 5, 2015
Est. primary completion date November 5, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- male and female participants ages 18 to 55 years old

Exclusion Criteria:

Active Worker's Compensation claim related to low back pain episode Active personal injury case related to low back pain episode Currently taking muscle relaxers, steroids, or narcotics

- Body mass index > 30 kg/m2

- Active cancer process

- Active infection

- Pregnancy

- High risk of osteoporosis assessed using the World Health Organization Fracture Risk Assessment Tool (included in submission)

- Osteogenic conditions (see screening questionnaire)

- Premature menopause

- Latex Allergies

- Lumbar spine or pelvic surgery

- Past spinal trauma producing spinal fracture

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Spinal Manipulation
HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints

Locations

Country Name City State
United States University of Denver Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
University of Denver

Country where clinical trial is conducted

United States, 

References & Publications (3)

Currie SJ, Myers CA, Durso C, Enebo BA, Davidson BS. The Neuromuscular Response to Spinal Manipulation in the Presence of Pain. J Manipulative Physiol Ther. 2016 May;39(4):288-93. doi: 10.1016/j.jmpt.2016.02.011. Epub 2016 Apr 6. — View Citation

Currie SJ, Myers CA, Krishnamurthy A, Enebo BA, Davidson BS. Methods of Muscle Activation Onset Timing Recorded During Spinal Manipulation. J Manipulative Physiol Ther. 2016 May;39(4):279-87. doi: 10.1016/j.jmpt.2016.03.001. Epub 2016 Apr 9. — View Citation

Myers CA, Enebo BA, Davidson BS. Optimized prediction of contact force application during side-lying lumbar manipulation. J Manipulative Physiol Ther. 2012 Nov-Dec;35(9):669-77. doi: 10.1016/j.jmpt.2012.10.010. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Response Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Total response expressed as a percentage of muscles "on". During spinal manipulation at the time of testing
Primary Muscle Activity Onset Delay Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Time delay between the manipulation force and the muscle activity During spinal manipulation at the time of testing
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