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Completed

NCT Number: NCT02261259

Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System

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.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MSU Osteopathic Manual Medicine, East Lansing, Michigan, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 NECK PAIN participants:

  • 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

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
  • 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.

Treatment and study plan

Osteopathic Manipulative Treatment

Procedure

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

Primary outcomes

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

    Time frame: Change from baseline to week 4 and from week 4 to 8

    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).

  2. Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy

    Time frame: Change from baseline to week 4 and from week 4 to 8

    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).

  3. Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy

    Time frame: Change from baseline to week 4 and from week 4 to 8

    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.

  4. Change from baseline to week 4 in neck force and muscle activation directionality

    Time frame: Change from baseline to week 4

    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.

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

    Time frame: Change from week 4 to 8

    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.

Secondary outcomes

  1. Change in Patient Reported Outcomes Measurement Information System (PROMIS)

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

    Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.

  2. Change in concomitant medication

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

    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.

  3. Change in neck disability

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

    Assesses weekly changes in functional activities related to neck disability with the Neck Disability Index questionnaire.

  4. Change in fear avoidance behavior

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

    Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 10, 2014
Registry last updated
Jan 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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