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

March 28, 2018 updated by: Stuart Currie, University of Denver
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
During spinal manipulation at the time of testing
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
During spinal manipulation at the time of testing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Denver

Investigators

  • Principal Investigator: Bradley S Davidson, PhD, University of Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2011

Primary Completion (ACTUAL)

November 5, 2015

Study Completion (ACTUAL)

November 5, 2015

Study Registration Dates

First Submitted

March 11, 2018

First Submitted That Met QC Criteria

March 28, 2018

First Posted (ACTUAL)

March 30, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LSM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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