Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

January 2, 2019 updated by: Jacek Cholewicki, Michigan State University

The overall goal of this project is to develop sensitive and objective clinical research tools for the assessment of postural control of the trunk. In order to accomplish this goal, we aim to quantify balance performance in an unstable seated task. Specifically, the investigators will quantify balance performance in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in balance performance after a single session of osteopathic manipulative treatment as well as after 4 sessions of osteopathic manipulative treatment and this improvement will be greater than any learning effect.

A secondary objective of this study is to quantify differences in patient-oriented outcome measures (e.g., self-reported pain, disability) in low back pain participants before and after osteopathic manipulative treatment. The investigators hypothesize that there will be a significant improvement in these self-reported outcomes following osteopathic manipulative treatment. The association between improvement in postural control parameters and patient-oriented measures will also be explored.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

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
    • Michigan
      • East Lansing, Michigan, United States, 48823
        • MSU Osteopathic Manipulative Medicine
      • Lansing, Michigan, United States, 48891
        • MSU Musculoskeletal Rehabilitation
      • Lansing, Michigan, United States, 48910
        • Michigan State University Center for Orthopedic Research

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

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

All participants must meet all of the inclusion criteria to participate in the study. Below is a list of inclusion criteria for LBP participants:

  • Age 21-65 years
  • Independently ambulatory
  • Able to speak and read English
  • Able to understand study procedures and to comply with them for the entire length of the study.
  • Willing to be randomized to either immediate or delayed treatment group.
  • Musculoskeletal pain - primarily in the low back region
  • Pain rating equal to or greater than 3 out of10 as indicated on the Numeric Rating Scale for Pain
  • Disability equal to or greater than 26% as indicated on the Oswestry Disability Questionnaire

Exclusion Criteria:

All candidates meeting any of the exclusion criteria at baseline will be excluded from study participation. Exclusion criteria will be self-reported. However, during each treatment session, the physicians will be watching for clinical signs and symptoms not consistent with physical findings that are suggestive of the presence of any of the exclusion criteria. In such a case, further treatment will be discontinued and the subject will be excluded.

Below is a list of exclusion criteria:

  • Inability or unwillingness of individual to give written informed consent.
  • Physical therapy or any other form of manual medicine (e.g., Osteopathic Manipulative Medicine, Chiropractic Manipulation, etc.), acupuncture or spinal injections within one month prior to study enrollment
  • Workers' compensation benefits in the past 3 months or ongoing medical legal issues
  • Possibly pregnant
  • Obesity (BMI>32)
  • Currently using electrical implants (e.g., cardiac pacemakers, drug delivery pumps, etc.)

History of:

  • Spinal surgery
  • Spinal fracture
  • Spinal infection (e.g., osteomyelitis)
  • Cancer

Unresolved symptoms from:

  • Head trauma
  • Inner ear infection with associated balance and coordination problems
  • Orthostatic hypotension
  • Uncontrolled hypertension
  • Vestibular disorder (e.g. vertigo)

Current diagnosis of:

  • Significant spinal deformity (e.g., scoliosis > 20 degrees, torticollis)
  • Ankylosing spondylitis
  • Spondylolisthesis grades III or IV
  • Cauda equine syndrome
  • Rheumatoid arthritis
  • Osteoporosis
  • Angina or congestive heart failure symptoms
  • Active bleeding or infection in the back
  • Blindness
  • Seizures
  • Neurologic disease (e.g., Parkinson's disease, multiple sclerosis, cerebral palsy, Alzheimer's disease, amyotrophic lateral sclerosis, stroke or transient ischemic attack in the past year, cervical dystonia)

Conditions recognized by a physician any time during the study:

  • Significant or worsening signs of neurologic deficit
  • Symptoms are not consistent with mechanical findings
  • Other conditions impeding protocol implementation

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate treatment
This arm receives osteopathic manipulative treatment shortly after enrollment
Procedure: Osteopathic manipulative treatment
Up to 4 sessions of osteopathic manipulative treatment (once per week)
Experimental: Delayed treatment
This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment
Procedure: Osteopathic manipulative treatment
Up to 4 sessions of osteopathic manipulative treatment (once per week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in postural control
Time Frame: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
Postural control will be assessed in an unstable seated task, in which subjects will be asked to balance on a specially designed seat. The average deviations from the neutral seat position will be measured in degrees.
Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
Change in trunk muscle reflex latency
Time Frame: Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.
Subjects will be pulling with their trunk on a cable held by an electromagnet. The electromagnet will be suddenly released. Trunk muscle response to sudden load release will be measured on electromyographical recordings in milliseconds.
Change from baseline to shortly after first treatment (1-2 days), from baseline to an expected average of week 4, and from week 4 to an expected average of week 8.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Change in fear avoidance behavior
Time Frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Change in concomitant medication
Time Frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks.
Assesses weekly changes in the use of medication for treating low back pain, including the type of medication and the quantity of medication (i.e., number of pills) with a questionnaire.
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).tcome measure until the end, an expected average of 8 weeks.
Change in Oswestry Disability Index
Time Frame: The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

Collaborators and Investigators

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

Sponsor

Michigan State University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Jacek Cholewicki, PhD, Michigan State University
  • Principal Investigator: Norman P Reeves, PhD, Michigan State University

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

Helpful Links

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)

April 1, 2014

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

August 31, 2018

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

October 9, 2014

First Posted (Estimate)

October 10, 2014

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCAM U19 AT006057 Project 1
  • 5U19AT006057-02 (U.S. NIH Grant/Contract)

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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