NCT03483714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
Last Updated

March 30, 2018

Status Verified

March 1, 2018

Enrollment Period

4.8 years

First QC Date

March 11, 2018

Last Update Submit

March 28, 2018

Conditions

Back Pain

Keywords

ManipulationSpinalelectromyographykineticskinematic

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (3)

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

Spinal ManipulationPROCEDURE

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

Acute Low back pain participantsChronic low back pain participantsHealthy Participants

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

community sample

You may qualify if:

  • male and female participants ages 18 to 55 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Denver

Denver, Colorado, 80208, United States

Location

Related Publications (3)

  • 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.

    PMID: 27072513RESULT

  • 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.

    PMID: 27059250RESULT

  • 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.

    PMID: 23206961RESULT

MeSH Terms

Conditions

Back Pain

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Bradley S Davidson, PhD

    University of Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 30, 2018

Study Start

February 1, 2011

Primary Completion

November 5, 2015

Study Completion

November 5, 2015

Last Updated

March 30, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)