Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants

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ClinicalTrials.gov Identifier: NCT03483714

Recruitment Status : Completed

First Posted : March 30, 2018

Last Update Posted : March 30, 2018

Sponsor:

Information provided by (Responsible Party):

Stuart Currie, University of Denver

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Back Pain	Procedure: Spinal Manipulation

Study Design

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Study Type :	Observational
Actual Enrollment :	60 participants
Observational Model:	Cohort
Time Perspective:	Cross-Sectional
Official Title:	Muscle Activation Characteristics During Spinal Manipulation in Healthy and Low Back Pain Participants
Actual Study Start Date :	February 1, 2011
Actual Primary Completion Date :	November 5, 2015
Actual Study Completion Date :	November 5, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Healthy Participants Spinal manipulation	Procedure: Spinal Manipulation HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints
Acute Low back pain participants Spinal Manipulation	Procedure: Spinal Manipulation HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints
Chronic low back pain participants Spinal Manipulation	Procedure: Spinal Manipulation HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints

Outcome Measures

Primary Outcome Measures :

Muscle Response [ Time Frame: During spinal manipulation at the time of testing ]
Muscle activity of the lumbar spinal musculature as measured by both surface and indwelling electromyography. Total response expressed as a percentage of muscles "on".
Muscle Activity Onset Delay [ Time Frame: During spinal manipulation at the time of testing ]
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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

community sample

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483714

Locations

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United States, Colorado
University of Denver
Denver, Colorado, United States, 80208

Sponsors and Collaborators

University of Denver

Investigators

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Principal Investigator:	Bradley S Davidson, PhD	University of Denver

More Information

Publications of Results:

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.

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.

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.

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Responsible Party:	Stuart Currie, Principle Investigator, University of Denver
ClinicalTrials.gov Identifier:	NCT03483714
Other Study ID Numbers:	LSM
First Posted:	March 30, 2018 Key Record Dates
Last Update Posted:	March 30, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Stuart Currie, University of Denver:


Manipulation Spinal electromyography kinetics kinematic

Additional relevant MeSH terms:

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Back Pain Low Back Pain Pain Neurologic Manifestations

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