Neck Pain
Conditions
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.
Interventions
PROCEDUREOsteopathic manipulative treatment
Up to 4 sessions of osteopathic manipulative treatment (once per week)
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Michigan State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from week 4 to 8 in neck force and muscle activation directionality | 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. |
| Change from baseline to week 4 and from week 4 to 8 in head position tracking accuracy | 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). |
| Change from baseline to week 4 and from week 4 to 8 in head force tracking accuracy | 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). |
| Change from baseline to week 4 and from week 4 to 8 in head position stabilization accuracy | 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. |
| Change from baseline to week 4 in neck force and muscle activation directionality | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in concomitant medication | 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. |
| Change in neck disability | 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. |
| Change in fear avoidance behavior | 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. |
| 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). | Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire. |
Countries
United States
Outcome results
None listed