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

January 7, 2020 updated by: A.T. Still University of Health Sciences

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kirksville, Missouri, United States, 63501
        • A. T. Still University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The effects of OMT on the amounts of immune cell biomarkers
Time Frame: 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
immediate after the 20 minutes OMT treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.T. Still University of Health Sciences

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2017

Primary Completion (Actual)

November 15, 2017

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

August 11, 2017

First Submitted That Met QC Criteria

August 11, 2017

First Posted (Actual)

August 15, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB #170804-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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