Neck PainNCT02261259
Effects of Osteopathic Manipulative Treatment on Neuromuscular Control of the Head-neck System
A study testing Osteopathic manipulative treatment in people with Neck Pain, run by Michigan State University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Osteopathic manipulative treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jun 2014to 13 Nov 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
MSU Osteopathic Manual Medicine
East Lansing, Michigan, 48823
MSU Musculoskeletal Rehabilitation
Lansing, Michigan, 48891
Michigan State University Center for Orthopedic Research
Lansing, Michigan, 48910
About this study
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.
- Conditions
- Neck Pain
- Being tested
- Osteopathic manipulative treatment, No intervention
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentProcedure or surgery
Up to 4 sessions of osteopathic manipulative treatment (once per week)
No interventionOther
No interventions for approximately 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| OMT first, then No intervention | Experimental | This arm received osteopathic manipulative treatment (OMT) for approximately 4 weeks (once per week), then received no intervention after for approximately 4 weeks. Receives: Procedure: Osteopathic manipulative treatment; Other: No intervention |
| No intervention, then OMT | Experimental | This arm received no intervention after for approximately 4 weeks, then received osteopathic manipulative treatment (OMT) for approximately 4 weeks (once per week). Receives: Procedure: Osteopathic manipulative treatment; Other: No intervention |
| Healthy control (no neck pain) | No intervention | In this arm, healthy controls are tested at baseline. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head Position Tracking Accuracy (Flexion/Extension)
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 (root mean square error measured in degrees with string potentiometers).
Measured: Measurements from Baseline, Week 4 and Week 8
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).
Measured: Baseline, Week 4, and Week 8
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 with their eyes open. Accuracy will be determined by measuring the amount of head displacement (measured in degrees with string potentiometers) during the perturbation trial.
Measured: Baseline, Week 4, and Week 8
Neck Force Variability
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. Measured forces are converted to moments (in Newton meters), and standard deviation of the moments are reported for flexion and extension. Larger the number in the variability indicates worse performance.
Measured: Baseline, Week 4 (crossover), Week 8
Neck 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 (SCM), splenius capitis (SPC), and upper trapezius (UT) muscles. Muscle directionality will be determined from the EMG magnitude in each direction of exertion and represented as specificity index. Specificity index ranges from 0 to 1, where 0 indicates no muscle activity and 1 indicates the highest muscle activity. Higher number indicates worst outcome.
Measured: Baseline, Week 4 (crossover), Week 8
Secondary outcomes (4)
Patient Reported Outcomes Measurement Information System (PROMIS)
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Measured: Measurements from Baseline and Week 4 (crossover point)
Change in Concomitant Medication
Assesses weekly changes in the use of medication with a questionnaire. Patients were asked to report medications used within the past 7 days.
Measured: Baseline, Week 4, Week 8
Change in Neck Disability
Assesses weekly changes in functional activities related to neck disability with the Neck Disability Index questionnaire.
Measured: Measurements from Baseline, Week 4 (crossover point), and Week 8
Change in Fear Avoidance Behavior
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire, assessing effects of fear-avoidance beliefs about physical activity and work. Patients rated statements on a scale from 0 (completely disagree) to 6 (completely agree). Scores are then summed for each category: "Physical activity" (total of 4 statements, ranges from 0 to 24), and "Work" (total of 7 statements ranges from 0 to 42). Higher scores indicate stronger fear-avoidance belief (i.e. worse outcome).
Measured: Measurements from Baseline, Week 4 (crossover point), and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2014 (estimated)
- Study start26 Jun 2014
- Primary completion13 Nov 2017
- Study completion13 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jacek Cholewicki, Michigan State University
- Investigators
- Jacek Cholewicki, PhD, Principal investigator, Michigan State UniversityNorman P Reeves, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02261259
- Sponsor's protocol ID
- NCCAM U19 AT006057 Project 3
- Other IDs
- 5U19AT006057-02
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2014
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 24262851Popovich JM Jr, Reeves NP, Priess MC, Cholewicki J, Choi J, Radcliffe CJ. Quantitative measures of sagittal plane head-neck control: a test-retest reliability study. J Biomech. 2015 Feb 5;48(3):549-54. doi: 10.1016/j.jbiomech.2014.11.023. Epub 2014 Nov 27.
PubMed 25553673Ramadan A, Choi J, Cholewicki J, Reeves NP, Popovich JM, Radcliffe CJ. Feasibility of Incorporating Test-Retest Reliability and Model Diversity in Identification of Key Neuromuscular Pathways During Head Position Tracking. IEEE Trans Neural Syst Rehabil Eng. 2019 Feb;27(2):275-282. doi: 10.1109/TNSRE.2019.2891525. Epub 2019 Jan 10.
PubMed 30629508Ramadan A, Boss C, Choi J, Peter Reeves N, Cholewicki J, Popovich JM Jr, Radcliffe CJ. Selecting Sensitive Parameter Subsets in Dynamical Models With Application to Biomechanical System Identification. J Biomech Eng. 2018 Jul 1;140(7):0745031-8. doi: 10.1115/1.4039677.
PubMed 29570752Cholewicki J, Popovich JM Jr, Reeves NP, DeStefano LA, Rowan JJ, Francisco TJ, Prokop LL, Zatkin MA, Lee AS, Sikorskii A, Pathak PK, Choi J, Radcliffe CJ, Ramadan A. The effects of osteopathic manipulative treatment on pain and disability in patients with chronic neck pain: A single-blinded randomized controlled trial. PM R. 2022 Dec;14(12):1417-1429. doi: 10.1002/pmrj.12732. Epub 2022 Jan 18.
PubMed 34719122