NCT02261259

Brief Summary

The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of head-neck motor control. In order to accomplish this goal, the investigators aim to quantify changes in head-neck motor control before and after osteopathic manipulative treatment. The investigators hypothesize that head-neck motor control will improve in neck pain participants after 4-weeks of treatment. Additionally, the investigators will compare position and force head-neck motor control between healthy controls and neck pain patients. The investigators hypothesize that baseline tests of position and force head-neck motor control will be better in healthy individuals than neck pain patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

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

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2017

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

3.5 years

First QC Date

September 19, 2014

Last Update Submit

January 2, 2019

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (5)

  • Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy

    Participants will be seated in an upright position with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The angular position of the head 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 head. Accuracy will be determined by taking the difference between the target position signal and the actual head 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 head force tracking accuracy

    Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. The pad will be attached to a load cell that monitors how much force is being generated by their head. 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 head. Accuracy will be determined by taking the difference between target force signal and the actual head 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 head position stabilization accuracy

    Participants will be sitting upright in a seat mounted to a robotic platform (Mikrolar Hexapod Robot) with their upper body secured to a backrest and will wear a head harness with an attached position sensor. The robotic platform will provide an angular perturbation to the participant about the cervical spine in the sagittal plane while the participant is asked to maintain (stabilize) their head position in the upright posture. Accuracy will be determined by measuring the amount of head 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 in neck force and muscle activation directionality

    Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.

    Change from baseline to week 4

  • Change from week 4 to 8 in neck force and muscle activation directionality

    Participants will be seated in an upright position with their upper body secured to a backrest and will be asked to generate force with their head against a fixed pad. They will be asked to performed 6-seconds isometric exertions in different directions. Surface EMG will be recorded from the sternocliedomastoid, splenius capitis, and upper trapezius muscles. Muscle directionality will be determined by the EMG magnitude in each direction of exertion.

    Change from week 4 to 8

Secondary Outcomes (4)

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

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  • Change in concomitant medication

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  • Change in neck disability

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  • Change in fear avoidance behavior

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

Study Arms (3)

Immediate treatment

EXPERIMENTAL

This arm receives osteopathic manipulative treatment shortly after enrollment

Procedure: Osteopathic manipulative treatment

Delayed treatment

EXPERIMENTAL

This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment

Procedure: Osteopathic manipulative treatment

Healthy control (no neck pain)

NO INTERVENTION

In this arm, healthy controls are tested at baseline.

Interventions

Osteopathic manipulative treatmentPROCEDURE

Up to 4 sessions of osteopathic manipulative treatment (once per week)

Delayed treatmentImmediate treatment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 cervical region lasting longer than 3 months
  • Pain rating greater than or equal to 3 out of 10 as indicated on the Numeric Rating Scale for Pain
  • Neck Disability greater than or equal to 30% as indicated on the Neck 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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: 24262851BACKGROUND

Related Links

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Jacek Cholewicki, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

  • Norman P Reeves, 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
Walter F. Patenge Professor

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 10, 2014

Study Start

June 1, 2014

Primary Completion

November 13, 2017

Study Completion

November 13, 2017

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

US(3)