search
Back to results

Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

Primary Purpose

Low Back Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic manipulative treatment
Sponsored by
Michigan State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MSU Osteopathic Manipulative Medicine
  • MSU Musculoskeletal Rehabilitation
  • Michigan State University Center for Orthopedic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Immediate treatment

Delayed treatment

Arm Description

This arm receives osteopathic manipulative treatment shortly after enrollment

This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment

Outcomes

Primary Outcome Measures

Change in postural control
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 in trunk muscle reflex latency
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.

Secondary Outcome Measures

Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Change in concomitant medication
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.
Change in Oswestry Disability Index
Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.
Change in fear avoidance behavior
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.

Full Information

First Posted
September 19, 2014
Last Updated
January 2, 2019
Sponsor
Michigan State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT02261233
Brief Title
Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Official Title
Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Terminated
Why Stopped
Funding for this project ended as of August 31, 2018
Study Start Date
April 1, 2014 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Michigan State University
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate treatment
Arm Type
Experimental
Arm Description
This arm receives osteopathic manipulative treatment shortly after enrollment
Arm Title
Delayed treatment
Arm Type
Experimental
Arm Description
This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment
Intervention Type
Procedure
Intervention Name(s)
Osteopathic manipulative treatment
Intervention Description
Up to 4 sessions of osteopathic manipulative treatment (once per week)
Primary Outcome Measure Information:
Title
Change in postural control
Description
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.
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.
Title
Change in trunk muscle reflex latency
Description
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.
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.
Secondary Outcome Measure Information:
Title
Change in Patient Reported Outcomes Measurement Information System (PROMIS)
Description
Assesses weekly changes in physical function, anxiety, depression, fatigue, sleep, satisfaction with social role, and pain with PROMIS-29 questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Title
Change in concomitant medication
Description
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.
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.
Title
Change in Oswestry Disability Index
Description
Assesses weekly changes in functional activities related to low back disability with the Oswestry Disability Index questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).
Title
Change in fear avoidance behavior
Description
Assesses weekly changes in fear avoidance behavior using the Fear Avoidance Beliefs questionnaire.
Time Frame
The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacek Cholewicki, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norman P Reeves, PhD
Organizational Affiliation
Michigan State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MSU Osteopathic Manipulative Medicine
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
MSU Musculoskeletal Rehabilitation
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48891
Country
United States
Facility Name
Michigan State University Center for Orthopedic Research
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11295888
Citation
Radebold A, Cholewicki J, Polzhofer GK, Greene HS. Impaired postural control of the lumbar spine is associated with delayed muscle response times in patients with chronic idiopathic low back pain. Spine (Phila Pa 1976). 2001 Apr 1;26(7):724-30. doi: 10.1097/00007632-200104010-00004.
Results Reference
background
Links:
URL
http://orthopedicresearch.msu.edu/
Description
Website for Michigan State University Center for Orthopedic Research
URL
http://nccam.nih.gov/
Description
Website for the National Center for Complementary and Alternative Medicine (Sponsor)

Learn more about this trial

Osteopathic Manipulative Treatment and Postural Control: Systems Engineering Approach

We'll reach out to this number within 24 hrs