The Effects of OMT on the Expression Patterns of Immune Cell Biomarkers

The study will be conducted over the course of one year. Forty men and women ages 20 to 55
years with at least one or more episodes of LBP in the past two weeks will be randomly
assigned into one of two groups - control or OMT groups. Twenty participants will be assigned
to each group. The study will begin recruitment in September 2017. Participants will be
recruited from the surrounding Kirksville area. Individuals who cannot tolerate OMT or have
coagulation disorders will be excluded. Potential participants will be excluded from the
study if they have had nonsteroidal anti-inflammatory medication in the 48 hours prior to the
study or if they have had corticosteroids in the 2 weeks prior to the study.

Participants will be randomly assigned into two groups, control or OMT using a random number
generator. Males and females will be randomized separately to ensure equal distribution into
the two study groups. Demographics including sex, age, and body mass index (BMI) will be
collected on all participants. All participants will receive two blood draws,with 8 ml each
draw: first blood draw immediately prior to intervention and second blood draw following the
intervention.

The OMT treatment will begin with a brief physical examination to identify somatic
dysfunction that the treating physician judges to be relevant to the individual participant's
low back pain. OMT will be performed to improve the somatic dysfunctions that the treating
physicians finds most relevant. The types of OMT techniques used will include muscle energy,
articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and
will be at the discretion of the treating physician. Additional techniques such as still,
counter strain, facilitated positional release, balanced ligamentous tension, and cranial
techniques may also be used at the discretion of the treating physician. The treatment will
conclude with 2 minutes of pedal lymphatic pumping technique. The total treatment time will
not to exceed 20 minutes.

The control group will wait in another room for approximately 30 minutes. To encourage
participation in the proposed study, participants who are assigned to the control group will
have an opportunity to receive OMT after the second blood draw.

The investigators shall determine the expression patterns of 60 immune cell biomarkers in
human peripheral blood mononuclear cells (PBMC) of the study participants, and determine the
ratio change of those 60 biomarkers, after the OMT treatment. The investigators shall compare
the effects of OMT treatment on the ratio change of those 60 biomarkers, with those in the
control group.

Inclusion Criteria:

- experienced at least one or more episodes of LBP in the past two weeks

- BMI (body mass index) < 30 kg/m2

- be able to lie on my back for 30 minutes

- be able to tolerate OMT

Exclusion Criteria

- Have spinal manipulation in the 48 hours prior to the study date

- Have corticosteroids in the 2 weeks prior to the study date

- Have nonsteroidal anti-inflammatory medication in the 48 hours prior to the study data

- Have spinal surgery in the lumbar or low thoracic spine

- Have congenital deformities of the lumbar spine such as spina bifida