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

Primary Purpose

Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal manipulation treatment
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • MSU Osteopathic Manual Medicine
  • MSU Musculoskeletal Rehabilitation
  • Michigan State University Center for Orthopedic Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Immediate treatment

Delayed treatment

Healthy control (no low back pain)

Arm Description

This arm receives spinal manipulation treatment shortly after enrollment

This arm receives spinal manipulation treatment approximately 4 weeks after enrollment

In this arm, healthy controls are tested at baseline.

Outcomes

Primary Outcome Measures

Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy
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 in trunk force tracking accuracy
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 in trunk position stabilization accuracy
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 in trunk force stabilization accuracy
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 in push stabilization accuracy
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 in pull stabilization accuracy
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.

Secondary Outcome Measures

Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Change in concomitant medication
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.
Change in back-related disability
Assesses weekly changes in functional limitations related to back pain with the Modified Oswestry Disability questionnaire.
Change in fear avoidance behavior
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Belief questionnaire.
Treatment effectiveness belief
Assesses the patient's belief in how effective the treatment will be prior to treatment using the Credibility Expectancy questionnaire.

Full Information

First Posted
September 19, 2014
Last Updated
January 25, 2019
Sponsor
Michigan State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02261246
Brief Title
Trunk Motor Control Performance Before and After Spinal Manipulation Treatment
Acronym
TMCSMT
Official Title
Trunk Motor Control Performance Before and After Spinal Manipulation Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
We no longer have the resources to complete enrollment
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate treatment
Arm Type
Experimental
Arm Description
This arm receives spinal manipulation treatment shortly after enrollment
Arm Title
Delayed treatment
Arm Type
Experimental
Arm Description
This arm receives spinal manipulation treatment approximately 4 weeks after enrollment
Arm Title
Healthy control (no low back pain)
Arm Type
No Intervention
Arm Description
In this arm, healthy controls are tested at baseline.
Intervention Type
Procedure
Intervention Name(s)
Spinal manipulation treatment
Intervention Description
Up to 4 sessions of spinal manipulation treatment (once per week).
Primary Outcome Measure Information:
Title
Change from baseline to week 4 and from week 4 to 8 in trunk position tracking accuracy
Description
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).
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in trunk force tracking accuracy
Description
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).
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in trunk position stabilization accuracy
Description
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.
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in trunk force stabilization accuracy
Description
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.
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in push stabilization accuracy
Description
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.
Time Frame
Change from baseline to week 4 and from week 4 to 8
Title
Change from baseline to week 4 and from week 4 to 8 in pull stabilization accuracy
Description
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.
Time Frame
Change from baseline to week 4 and from week 4 to 8
Secondary Outcome Measure Information:
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Description
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end of week 8
Title
Change in concomitant medication
Description
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.
Time Frame
The expected average is weekly for this outcome measure until the end of week 8
Title
Change in back-related disability
Description
Assesses weekly changes in functional limitations related to back pain with the Modified Oswestry Disability questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end of week 8
Title
Change in fear avoidance behavior
Description
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Belief questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end of week 8
Title
Treatment effectiveness belief
Description
Assesses the patient's belief in how effective the treatment will be prior to treatment using the Credibility Expectancy questionnaire.
Time Frame
This outcome measure will be assessed at baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman P Reeves, PhD
Organizational Affiliation
Sumaq Life LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacek Cholewicki, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MSU Osteopathic Manual Medicine
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
MSU Musculoskeletal Rehabilitation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48891
Country
United States
Facility Name
Michigan State University Center for Orthopedic Research
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24262851
Citation
Reeves NP, Popovich JM Jr, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Reliability of assessing trunk motor control using position and force tracking and stabilization tasks. J Biomech. 2014 Jan 3;47(1):44-9. doi: 10.1016/j.jbiomech.2013.10.018. Epub 2013 Oct 22.
Results Reference
background
Links:
URL
http://orthopedicresearch.msu.edu/
Description
Website for Michigan State University Center for Orthopedic Research
URL
http://nccam.nih.gov/
Description
Website for the National Center for Complementary and Alternative Medicine (Sponsor)

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Trunk Motor Control Performance Before and After Spinal Manipulation Treatment

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