Clinical trial NCT02261259: Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
Official title: Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2014-10-10
Enrollment: 154
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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 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.

Primary outcomes:
measure: Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy
timeFrame: Change from baseline to week 4 and from week 4 to 8
measure: Change from baseline to week 4 in neck force and muscle activation directionality
timeFrame: Change from baseline to week 4
measure: Change from week 4 to 8 in neck force and muscle activation directionality
timeFrame: Change from week 4 to 8
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS)
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
measure: Change in concomitant medication
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
measure: Change in neck disability
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
measure: Change in fear avoidance behavior
timeFrame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Other outcomes:
Locations:
city: East Lansing
country: United States
facility: MSU Osteopathic Manual Medicine
state: Michigan
city: Lansing
country: United States
facility: MSU Musculoskeletal Rehabilitation
state: Michigan
city: Lansing
country: United States
facility: Michigan State University Center for Orthopedic Research
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jacek Cholewicki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Norman P Reeves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.