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

Sponsor

A.T. Still University of Health Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT03250312

Collaborator

(none)

Enrollment

Location

Arms

23.6

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study intends to understand the effects of osteopathic manipulative treatment (OMT) on the expression patterns of 60 immune cell biomarkers in the peripheral blood mononuclear cells (PBMC) of each participant, before and after intervention - OMT or seated control. This study will utilize participants with a history of low back pain (LBP), and will identify and validate those immune cell biomarkers that change in most participants after OMT, by using the novel protein subcellular localization (PSL) microarray technology. This study intends to uncover the important immune cells affected by OMT techniques, therefore to uncover the molecular mechanisms of OMT.

Condition or Disease	Intervention/Treatment	Phase
Osteopathic Manipulation Low Back Pain Biomarkers	Other: The Osteopathic Manipulation	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Single (Investigator)

Masking Description:

The investigators who determine the expression profile of the 60 immune cell biomarkers would not know which group does each sample belong to

Primary Purpose:

Basic Science

Official Title:

The Effects of Osteopathic Manipulations on the Expression Patterns of Immune Cell Biomarkers

Actual Study Start Date :

Sep 13, 2017

Actual Primary Completion Date :

Nov 15, 2017

Actual Study Completion Date :

Aug 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: The OMT group This group will be treated by the osteopathic manipulation techniques (OMT). 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. The total treatment time will not to exceed 20 minutes.	Other: The Osteopathic Manipulation 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
No Intervention: The control group 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

Arm

Intervention/Treatment

Active Comparator: The OMT group

This group will be treated by the osteopathic manipulation techniques (OMT). 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. The total treatment time will not to exceed 20 minutes.

Other: The Osteopathic Manipulation

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

No Intervention: The control group

Outcome Measures

Primary Outcome Measures

The effects of OMT on the amounts of immune cell biomarkers [immediate after the 20 minutes OMT treatment]
Measure the ratio change of immune cell biomarkers in the PBMC cell of Low back pain patients after the OMT treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	A. T. Still University of Health Sciences	Kirksville	Missouri	United States	63501

Sponsors and Collaborators

A.T. Still University of Health Sciences

Investigators

Principal Investigator: Karen Snider, D. O., A.T. Still University of Health Sciences

Study Documents (Full-Text)

More Information

Publications

Responsible Party:

A.T. Still University of Health Sciences

ClinicalTrials.gov Identifier:

NCT03250312

Other Study ID Numbers:

IRB #170804-001

First Posted:

Aug 15, 2017

Last Update Posted:

Jan 13, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by A.T. Still University of Health Sciences

Osteopathic manipulation

low back pain

immune cells

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Jan 13, 2020