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

NCT03250312 | Terminated DMC

• 1 other identifier: IRB #170804-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopathic Manipulation; Low Back Pain; Biomarkers

Keywords

Osteopathic manipulation; low back pain; immune cells

Outcome Measures

Primary Outcomes (1)

• The effects of OMT on the amounts of immune cell biomarkers

  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

Study Arms (2)

The OMT group

ACTIVE COMPARATOR

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 control group

NO INTERVENTION

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

Interventions

The Osteopathic Manipulation OTHER

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 OMT group

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• A.T. Still University of Health Sciences: lead

Study Sites (1)

A. T. Still University of Health Sciences

Kirksville, Missouri, 63501, United States

Location

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MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Snider, D. O.

  A.T. Still University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators who determine the expression profile of the 60 immune cell biomarkers would not know which group does each sample belong to
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 11, 2017
• First Posted: August 15, 2017
• Study Start: September 13, 2017
• Primary Completion: November 15, 2017
• Study Completion: August 31, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)