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CompletedNCT03483714Updated Mar 30, 2018

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

An observational study in Back Pain, sponsored by University of Denver. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-30.

Sponsored by University of Denver · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
60
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Back Pain

Keywords

  • Manipulation
  • Spinal
  • electromyography
  • kinetics
  • kinematic
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

community sample

Inclusion criteria

  • male and female participants ages 18 to 55 years old

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy Participants

    Spinal manipulation

    Procedure: Spinal Manipulation

  • Acute Low back pain participants

    Spinal Manipulation

    Procedure: Spinal Manipulation

  • Chronic low back pain participants

    Spinal Manipulation

    Procedure: Spinal Manipulation

Interventions

  • ProcedureSpinal Manipulation

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

05

What researchers measure

Primary outcomes

  1. 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".

    Time frame: During spinal manipulation at the time of testing

  2. 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

    Time frame: During spinal manipulation at the time of testing

06

Study locations

1 site
  • University of Denver
    Denver, Colorado 80208, United States
07

References and documents

Publications

  • 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. PubMed 27072513 ↗
  • 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. PubMed 27059250 ↗
  • 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. PubMed 23206961 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03483714
Lead sponsor
University of Denver
Responsible party
Stuart Currie (Principle Investigator, University of Denver) — Principal investigator
First posted
Mar 30, 2018
Start date
Feb 1, 2011
Primary completion
Nov 5, 2015
Completion
Nov 5, 2015
Last update
Mar 30, 2018

Study contacts

Bradley S Davidson, PhD
principal investigator · University of Denver

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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