Trunk Motor Control Performance Before and After Spinal Manipulation Treatment

NCT02261246 | Terminated DMC

• 2 other identifiers: NCCAM U19 AT006057 Project 25U19AT006057-02
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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.

  Change from baseline to week 4 and from week 4 to 8

Secondary Outcomes (5)

• Change in Patient Reported Outcomes Measurement Information System (PROMIS)

  The expected average is weekly for this outcome measure until the end of week 8

• Change in concomitant medication

  The expected average is weekly for this outcome measure until the end of week 8

• Change in back-related disability

  The expected average is weekly for this outcome measure until the end of week 8

• Change in fear avoidance behavior

  The expected average is weekly for this outcome measure until the end of week 8

• Treatment effectiveness belief

  This outcome measure will be assessed at baseline

Study Arms (3)

Immediate treatment

EXPERIMENTAL

This arm receives spinal manipulation treatment shortly after enrollment

Procedure: Spinal manipulation treatment

Delayed treatment

EXPERIMENTAL

This arm receives spinal manipulation treatment approximately 4 weeks after enrollment

Procedure: Spinal manipulation treatment

Healthy control (no low back pain)

NO INTERVENTION

In this arm, healthy controls are tested at baseline.

Interventions

Spinal manipulation treatment PROCEDURE

Up to 4 sessions of spinal manipulation treatment (once per week).

Delayed treatment; Immediate treatment

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Michigan State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (3)

MSU Osteopathic Manual Medicine

East Lansing, Michigan, 48823, United States

Location

MSU Musculoskeletal Rehabilitation

Lansing, Michigan, 48891, United States

Location

Michigan State University Center for Orthopedic Research

Lansing, Michigan, 48910, United States

Location

Related Publications (1)

• 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.

  PMID: 24262851 BACKGROUND

Related Links

• Website for Michigan State University Center for Orthopedic Research
• Website for the National Center for Complementary and Alternative Medicine (Sponsor)

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Norman P Reeves, PhD

  Sumaq Life LLC

  PRINCIPAL INVESTIGATOR

• Jacek Cholewicki, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: October 10, 2014
• Study Start: June 1, 2014
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: January 29, 2019

Record last verified: 2019-01

Locations

US (3)