The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults: A Pilot Study
Phase: NA
Conditions: Osteopathy in Diseases Classified Elsewhere
Sponsor: Des Moines University

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Title of Study: The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults: 
A Pilot Study 
 
Authors: Thomas Mehner, OMS IV1; Krista Hoevemeyer, OMS IV1; Ryan McMunn, OMS IV1; Kai 
Yuan Teng, OMS IV1; Jose Figueroa, DO1; and Chunfa Jie, PhD2 
Unique Protocol ID: IRB-2019-26 
October 1, 2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Project Purpose 
The purpose of this proposed study is to investigate the mechanism of osteopathic manipulative 
treatment (OMT). Previous studies have shown the effectiveness of OMT on decreasing patient 
symptoms by removing somatic dysfunctions. The procedure (OMT) of removing somatic 
dysfunctions has been explained and the mechanism of removing somatic dysfunction by OMT 
has been theorized. It is thought that by removing somatic dysfunction, OMT changes 
proprioception. This study seeks to identify if proprioception is the mechanism by which OMT 
exerts its effect on correcting somatic dysfunction. The investigators will investigate this affect 
globally throughout the body. Proprioception is the body's position sense, meaning, the mind's 
ability to know where the body is in space. The measurement of proprioception will include 
having participants complete standing tests with both legs and single-leg on a force plate. The 
force plate is a measurement of balance and sway of a participant. Balance has input from 
proprioception, the cerebellum, vision, and the vestibular system. While the investigators cannot 
eliminate all of the components, the investigators will test participants with eyes closed to get 
closer to isolating proprioception. The hypothesis is that OMT will improve proprioception 
supporting the thought that OMT removes somatic dysfunction by affecting proprioception. 
Study design and procedures: 
 
Participants will go through an informed consent process, fill out a screening questionnaire and 
will undergo neurological testing. If there are any abnormalities in their neurological testing or 
they meet exclusion criteria, they will not be included in the study. The neurological testing will 
include reflex testing, sensation testing, strength testing, and coordination and balance tests.  
 
Participants will then be randomized into 2 groups. One control and one treatment. 
 
Each group will have their balance measured using the portable force plate. Participants will be 
tested on both feet with arms crossed and eyes open for 60 seconds, and both feet with arms 
crossed and eyes closed for 60 seconds. Then they will be given 15 seconds to practice 
standing on the force plate on only their right leg with eyes open and arms crossed. The 
investigators will then test their balance on their right leg with arms crossed and eyes open for 30 
seconds. They will be given 15 seconds to practice standing on their right leg with their arms 
crossed and eyes closed, and then will have their balance tested on their right leg with arms 
crossed and eyes closed for 30 seconds. The same sequence of events will take place for the 
left leg as their right leg.  This sequence of measurements will take place at the beginning and 
end of their first treatment visit.  For the standing test with eyes closed and all single leg tests a 
fellow will be standing beside the force plate with an arm and either side of the patient to prevent 
the participant from falling and hurting themselves.  
 
The force plate calculates the center of mass of the participant, the area that is covered by the 
center of mass, the length of the path of center of mass, the velocity of its motion, and the 
maximum sway in the x and y planes. 
During the single leg tests, The investigators will also record the time of when the participant 
brings the other foot down, touches the two legs together, or if the sternum becomes outside the 
borders of the pelvis, if they do lose their balance The test duration will be 30 seconds, as stated 
previously.  
 
Between the two balance tests, the treatment group will receive a full-body osteopathic 
manipulative treatment according to the Common Compensatory Pattern (CCP). CCP is a 

treatment approach developed by Dr. Zinc that addresses the transition areas of the body. The 
treatment will be given by one of the four fellows under supervision by a licensed physician and 
last 10-20 minutes. The treatment will include the following body regions: 
Occipito-atlantal Joint 
Thoracic Inlet 
Thoraco-lumbar shift 
Lumbo-pelvic roll 
Ribs 
Sacrum 
Pelvis 
Upslip 
Upper extremity 
Lower extremity 
 
The fellows will diagnose somatic dysfunctions within these body regions, treat, and reassess to 
make sure the somatic dysfunctions are resolved. The physician will perform a spinal sweep and 
side-to-side height assessments before and after treatment to verify there was improvement in 
somatic dysfunctions.  
 
After the treatment, the treatment group will walk around the perimeter of the OMM lab three 
times before retesting their balance.  
 
The control group will be asked to lay on an OMM treatment for 15 minutes. They will then walk 
around the perimeter of the OMM lab three times before retesting their balance.  
 
The treatment group will come for five visits. The first visit will include the informed consent and 
neurological exam. The second visit will include a balance measurement, a treatment, and a 
follow-up balance measurement immediately after the treatment. The next two visits will consist 
only of osteopathic treatments. Each visit will be spaced one week apart. The participant will 
come back a week after their last treatment and complete follow-up balance testing. 
 
The control group will have a total of five visits. They will have the same initial visit as the 
treatment group with informed consent and neurological exam. Their second visit will consist of a 
balance measurement, have somatic dysfunctions be diagnosed, yet not be treated and have an 
immediate follow-up measurement. The third and fourth visits will consist of diagnosing somatic 
dysfunctions without any treatment. The last visit will consist of a follow-up balance testing. Each 
of these visits will be one week apart.  
 
The data from the force that will be used includes area that the center of mass covers, length of 
pathway of center of mass, velocity of the center of mass, medial-lateral sway, and anterior-
posterior sway. The investigators will also use the length of time participants were able to stand 
on one leg without losing their balance (without moving their knee or chest outside of their 
midline, their foot leaving the platform, touching their opposite foot to the ground, or letting their 
legs touch). 
Inclusion criteria: 
Participants must be 18-40 years old, have the ability to give consent, and be able to bare weight 
on both feet. 
Exclusion criteria: 

Participants will be excluded from the study if they have had manipulation performed by a D.O., 
physical therapist, or chiropractor in the last two months, have had surgery in the six months, 
had broken or fractured a bone in the last six months, have an abnormal neurological exam, or 
has a cerebellar dysfunction or ataxia, has a condition that impairs balance (including orthostatic 
hypertension, otoneurologic conditions, or arrhythmias). Patient will also be asked about 
dizziness, fainting, previous falls, fever, weight loss, pain that wakes them up at night, morning 
stiffness or localized bone pain and would be evaluated if participants needed to be excluded for 
medical treatment. 
Recruitment: 
Recruitment will occur through advertisements using social media, flyers, word of mouth, and 
class announcements. The advertisement is attached and will also function as a script for the 
class announcements. Email addresses will be collected from participants for appointment 
scheduling and reminders. 
Informed Consent: 
The investigators will schedule the informed consent process to be 45 minutes to allow 
participants to decide if they wish to go forward with the study. Informed consent will begin by 
explaining the purpose of the study. The investigators will then explain the timeline of the study 
including the randomization of a treatment and control group and scheduling of visits. The 
fellows will also give an overview of what OMM is and some examples of the treatment styles 
that will be used, and the body regions that will potentially be treated. There will be five minutes 
provided for questions. The OMM fellows will then explain how the force plate is used and 
demonstrate what participants will have to perform on the force plate, and explain when balance 
measurements will be taken. The reimbursement schedule will then be discussed and what is 
required for full reimbursement. Lastly, 15 minutes will be provided for any questions. After 
completion of consent, the participants will fill out a screening questionnaire and go through a 
neurological examination. 
The principal investigator and four research participants will be involved with the informed 
consent process. They have all completed CITI training. The four research assistants will be 
explaining the study and answering questions during the informed consent process with the 
supervision of the principal investigator. The informed consent documents will be signed with a 
research assistant present after all questions have been answered and will collected by the 
research assistant. The forms will be kept in a locked drawer within a locked office for the 
duration of the study. 
Data analysis: 
According to the project study design, data will be collected at three occasions for six balance 
measurement variables of interest. The six variable include length of pathway of center of mass, 
area covered by center of mass, velocity of center of mass, medial-lateral sway, posterior-
anterior sway, and time lapsed during the single leg tests.   Summary descriptive statistics will be 
first obtained for the selected variables and demographics covariates as appropriate.  For a 
particular variable, the change between pre- (or baseline) and post- treatment during the first 
week reflects the immediate treatment effect while the difference between the pre-treatment 
baseline and the last measurement during week 4 represents the long-term lasting accumulative 
effect.  The data bear the characteristics of repeated measurements on the same study 
participants since more than one measurements are taken on the same study participant over 
time.  Thus, it is usually plausible to assume the measurements on the same individual subjects 

are correlated. Ignoring the covariance between such measurements may result in erroneous 
statistical inference, and avoiding it by data transformation may result in inefficient statistical 
inference.  The statistical technique of linear mixed model allows the covariance structure to be 
integrated into the modeling while accounting for the randomness of the study subjects.  Thus, 
the data will be analyzed separately for each variable with a linear mixed-effect model with 
repeated measures design to assess the OMT effects on the balance measurement metrics over 
time.  In the model fitting process, several candidate covariance structures will be selected and 
evaluated according to the experimental design (i.e., unequal spacing of the time points but with 
the same time points across the study participants, within-subject correlation over time and 
convergence of model fitting), out of which one optimal covariance structure will be selected by 
the Akaike information criterion (AIC) criteria. On the basis of the chosen models for the 
respective variables, statistical contrasts will be set up to compare the mean values of variable 
measurements between time points to assess the immediate and long-term effects of OMT 
treatment.  Tukey procedure for the multiple testing adjustment will be used to compute the 
adjusted p-value in case of need.