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.
Sex: All, ages: 21 Years to 65 Years, accepts healthy volunteers
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.
Participant flow
| Milestone | OMT First, Then No Intervention | No Intervention, Then OMT | Healthy Control (no Neck Pain) |
|---|
| Started | 49 | 48 | 41 |
| Visit 1 - patient reported outcome (baseline) | 44 | 43 | 40 |
| Visit 1 - biomechanical testing (baseline) | 41 | 39 | 40 |
| Visit 2 - patient reported outcome (cross over) | 38 | 37 | 0 |
| Visit 2 - biomechanical testing (cross over) | 37 | 37 | 0 |
| Visit 3 - patient reported outcome | 37 | 37 | 0 |
| Visit 3 - biomechanical testing | 37 | 37 | 0 |
| Completed | 37 | 37 | 40 |
| Not completed | 12 | 11 | 1 |
Outcome results
- Head Position Tracking Accuracy (Flexion/Extension) (Primary), Mean, Degrees: OMT First, Then No Intervention 1.2104 +/- 0.0641; No Intervention, Then OMT 1.2306 +/- 0.0746; Healthy Control (no Neck Pain) 1.2108 +/- 0.0579 (p 0.118)
- Head Force Tracking Accuracy (Primary), Mean, Newtons: OMT First, Then No Intervention 1.2186 +/- 0.0750; No Intervention, Then OMT 1.2601 +/- 0.1187; Healthy Control (no Neck Pain) 1.1930 +/- 0.0527 (p 0.539)
- Head Position Stabilization Accuracy (Primary), Mean, Degrees: OMT First, Then No Intervention 1.5560 +/- 0.4951; No Intervention, Then OMT 1.7926 +/- 0.6542; Healthy Control (no Neck Pain) 1.6905 +/- 0.4729 (p 0.880)
- Neck Force Variability (Primary), Mean, Nm: OMT First, Then No Intervention 0.1513 +/- 0.0884; No Intervention, Then OMT 0.2530 +/- 0.3718; Healthy Control (no Neck Pain) 0.1593 +/- 0.0831 (p 0.075)
- Neck Muscle Activation Directionality (Primary), Mean, Units on a scale: OMT First, Then No Intervention 0.3863 +/- 0.1556; No Intervention, Then OMT 0.4476 +/- 0.1402; Healthy Control (no Neck Pain) 0.4786 +/- 0.1520 (p 0.297)
- Patient Reported Outcomes Measurement Information System (PROMIS) (Secondary), Least squares mean, t-score: Osteopathic Manipulative Treatment (OMT) 57.04 +/- 0.84; No Intervention 56.97 +/- 0.85 (p 0.950)
- Change in Concomitant Medication (Secondary), Mean, Number of medication: OMT First, Then No Intervention 2.2 +/- 2.6; No Intervention, Then OMT 1.9 +/- 2.6; Healthy Control (no Neck Pain) 0.7 +/- 1.1 (p 0.3183)
- Change in Neck Disability (Secondary), Mean, % (out of 50): OMT First, Then No Intervention 34.6 +/- 9.7; No Intervention, Then OMT 37.5 +/- 9.1; Healthy Control (no Neck Pain) 1.9 +/- 3.2 (p 0.010)
- Change in Fear Avoidance Behavior (Secondary), Mean, scores on a scale: OMT First, Then No Intervention 13.32 +/- 7.91; No Intervention, Then OMT 14.65 +/- 9.10; Healthy Control (no Neck Pain) 4.28 +/- 8.31 (p 0.896)
Adverse events
Time frame: Baseline-Week 8
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|
| Osteopathic Manipulative Treatment (OMT) | 0/86 (0.0%) | 0/86 (0.0%) | 46/86 (53.5%) |
| No Intervention | 0/86 (0.0%) | 0/86 (0.0%) | 32/86 (37.2%) |
| Healthy Control (no Neck Pain) | 0/40 (0.0%) | 0/40 (0.0%) | 8/40 (20.0%) |
Other adverse events by term
| Term | Organ system | Osteopathic Manipulative Treatment (OMT) | No Intervention | Healthy Control (no Neck Pain) |
|---|
| Back pain | Musculoskeletal and connective tissue disorders | 8/86 | 1/86 | 0/40 |
| Cold | Respiratory, thoracic and mediastinal disorders | 6/86 | 4/86 | 0/40 |
| Myalgia | Musculoskeletal and connective tissue disorders | 19/86 | 10/86 | 4/40 |
| Neck pain | Musculoskeletal and connective tissue disorders | 24/86 | 13/86 | 3/40 |
| Muscle fatigue | Musculoskeletal and connective tissue disorders | 14/86 | 7/86 | 1/40 |
| Headahce | Nervous system disorders | 6/86 | 5/86 | 0/40 |