Trunk Motor Control Performance Before and After Spinal Manipulation Treatment (TMCSMT)

January 25, 2019 updated by: Jacek Cholewicki, Michigan State University
The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of trunk motor control. In order to accomplish this goal, the investigators aim to quantify changes in trunk motor control before and after spinal manipulation treatment. The investigators hypothesize that trunk motor control will improve in the low back pain participants after 4-weeks of spinal manipulation treatment. Additionally, the investigators will compare position and force trunk motor control between healthy controls and low back pain patients. The investigators hypothesize that baseline tests of position and force trunk motor control will be better in healthy individuals than low back pain patients.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • MSU Osteopathic Manual Medicine
      • Lansing, Michigan, United States, 48891
        • MSU Musculoskeletal Rehabilitation
      • Lansing, Michigan, United States, 48910
        • Michigan State University Center for Orthopedic Research

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for ALL participants:

  • Age 21-65 years
  • Independently ambulatory
  • Able to speak and read English
  • Able to understand study procedures and to comply with them for the entire length of the study.

Below is an additional list of inclusion criteria for low back pain participants:

  • Willing to be randomized to either immediate or delayed treatment group.
  • Musculoskeletal pain - primarily in the lumbar region
  • Pain rating greater or equal to 3 out of 10 as indicated on the Numeric Rating Scale for Pain
  • Back Disability greater or equal to 26% as indicated on the Oswestry Disability Index

Exclusion Criteria:

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.

Below is a list of exclusion criteria for ALL participants:

  • Inability or unwillingness of individual to give written informed consent.
  • Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment
  • Workers' compensation benefits in the past 3 months or ongoing medical legal issues
  • Possibly pregnant
  • Extreme obesity (BMI>36)
  • Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.)

History of:

  • Spinal surgery
  • Spinal fracture
  • Spinal infection (e.g., osteomyelitis)
  • Cancer

Unresolved symptoms from:

  • Head trauma
  • Inner ear infection with associated balance and coordination problems
  • Orthostatic hypotension
  • Uncontrolled hypertension
  • Vestibular disorder (e.g. vertigo)

Current diagnosis of:

  • Significant spinal deformity (e.g., scoliosis > 20 degrees, torticollis)
  • Ankylosing spondylitis
  • Spondylolisthesis grades III or IV
  • Cauda equine syndrome
  • Rheumatoid arthritis
  • Osteoporosis
  • Angina or congestive heart failure symptoms
  • Active bleeding or infection in the back
  • Blindness
  • Seizures
  • Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia)

Conditions recognized by a physician any time during the study:

  • Significant or worsening signs of neurologic deficit
  • Symptoms are not consistent with mechanical findings
  • Other conditions impeding protocol implementation

Below is an additional exclusion criterion for healthy control participants:

• Based on the minimal clinically important difference of 2 points (Childs et al., 2005), "healthy controls" with 2 points or greater pain on NRS will not be eligible to participate.

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment
This arm receives spinal manipulation treatment shortly after enrollment
Procedure: Spinal manipulation treatment
Up to 4 sessions of spinal manipulation treatment (once per week).
Experimental: Delayed treatment
This arm receives spinal manipulation treatment approximately 4 weeks after enrollment
Procedure: Spinal manipulation treatment
Up to 4 sessions of spinal manipulation treatment (once per week).
No Intervention: Healthy control (no low back pain)
In this arm, healthy controls are tested at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy
Time Frame: Change from baseline to week 4 and from week 4 to 8
Participants will be in a seated position during the position tracking task and will wear a chest harness with an attached position sensor. The angular position of the trunk will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by moving their trunk. Accuracy will be determined by taking the difference between the target position signal and the actual trunk position (measured in degrees with string potentiometers).
Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in trunk force tracking accuracy
Time Frame: Change from baseline to week 4 and from week 4 to 8
Participants will be in a seated position and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The force level will be displayed on a monitor 1 meter in front of the participants and they will be asked to follow a moving target by generating force with their trunk. Accuracy will be determined by taking the difference between target force signal and the actual trunk force (measured in Newtons with the load cell).
Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in trunk position stabilization accuracy
Time Frame: Change from baseline to week 4 and from week 4 to 8
Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will wear a chest harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) their trunk position in the upright posture. Accuracy will be determined by measuring the amount of trunk displacement (measured in degrees with string potentiometers) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in trunk force stabilization accuracy
Time Frame: Change from baseline to week 4 and from week 4 to 8
Participants will be sitting in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) and will be asked to generate force with their trunk against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their trunk. The robotic platform will provide an angular perturbation to the participant about the lumbar spine in the sagittal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their trunk (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in push stabilization accuracy
Time Frame: Change from baseline to week 4 and from week 4 to 8
Participants will be standing and will be asked to generate push force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8
Change from baseline to week 4 and from week 4 to 8 in pull stabilization accuracy
Time Frame: Change from baseline to week 4 and from week 4 to 8
Participants will be standing and will be asked to generate pull force while holding onto a bar (arms along the body, elbows flexed at 90º). The bar will be attached to a load cell that monitors how much force is being applied with the hands. The robotic platform will provide a linear movement (perturbation) of the bar in the horizontal plane while the participant is asked to maintain (stabilize) a static force level (projected on a screen in front of them) with their hands (10% of the average maximum trunk moment). Accuracy will be determined by measuring the difference between the target force level and the actual force level maintained (measured in Newtons with a load cell) during the perturbation trial.
Change from baseline to week 4 and from week 4 to 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: The expected average is weekly for this outcome measure until the end of week 8
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
The expected average is weekly for this outcome measure until the end of week 8
Change in concomitant medication
Time Frame: The expected average is weekly for this outcome measure until the end of week 8
Assesses weekly changes in the use of medication for treating neck pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
The expected average is weekly for this outcome measure until the end of week 8
Change in back-related disability
Time Frame: The expected average is weekly for this outcome measure until the end of week 8
Assesses weekly changes in functional limitations related to back pain with the Modified Oswestry Disability questionnaire.
The expected average is weekly for this outcome measure until the end of week 8
Change in fear avoidance behavior
Time Frame: The expected average is weekly for this outcome measure until the end of week 8
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Belief questionnaire.
The expected average is weekly for this outcome measure until the end of week 8
Treatment effectiveness belief
Time Frame: This outcome measure will be assessed at baseline
Assesses the patient's belief in how effective the treatment will be prior to treatment using the Credibility Expectancy questionnaire.
This outcome measure will be assessed at baseline

Collaborators and Investigators

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

Sponsor

Michigan State University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jacek Cholewicki, PhD, Michigan State University
  • Principal Investigator: Norman P Reeves, PhD, Sumaq Life LLC

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

Helpful Links

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)

June 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCAM U19 AT006057 Project 2
  • 5U19AT006057-02 (U.S. NIH Grant/Contract)

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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