Osteopathy in Diseases Classified Elsewhere Clinical Trial
Official title:
The Effect of Osteopathic Manipulative Treatment (OMT) on Proprioception in Adults: A Pilot Study
Participants will be recruited from the Des Moines University community and randomized into treatment and control groups. The treatment group will undergo three treatments one week apart. The control group will have an osteopathic structural exam without treatment. During the first treatment weeks both groups will undergo balance testing on a force plate pre and post intervention. Additional balance testing will take place one week after last intervention. Six variables will be compared between groups used a linear mixed model analysis.
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 someone will be standing beside the force plate with an arm and
either side of the participant 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 lab for 5
minutes before retesting their balance.
The control group will be asked to lay on an OMM (Osteopathic Manual Medicine) treatment for
15 minutes. They will then walk around the perimeter of the lab for 5 minutes 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).
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.
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