NCT02261233

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Apr 2014

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

January 4, 2019

Status Verified

January 1, 2019

Enrollment Period

4.4 years

First QC Date

September 19, 2014

Last Update Submit

January 2, 2019

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

  • 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 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

    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 Outcomes (4)

  • Change in Patient Reported Outcomes Measurement Information System (PROMIS)

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  • Change in concomitant medication

    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

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

  • Change in fear avoidance behavior

    The expected average is weekly for this outcome measure until the end (expected average of 8 weeks).

Study Arms (2)

Immediate treatment

EXPERIMENTAL

This arm receives osteopathic manipulative treatment shortly after enrollment

Procedure: Osteopathic manipulative treatment

Delayed treatment

EXPERIMENTAL

This arm receives osteopathic manipulative treatment approximately 4 weeks after enrollment

Procedure: Osteopathic manipulative treatment

Interventions

Osteopathic manipulative treatmentPROCEDURE

Up to 4 sessions of osteopathic manipulative treatment (once per week)

Delayed treatmentImmediate treatment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

MSU Osteopathic Manipulative Medicine

East Lansing, Michigan, 48823, United States

Location

MSU Musculoskeletal Rehabilitation

Lansing, Michigan, 48891, United States

Location

Michigan State University Center for Orthopedic Research

Lansing, Michigan, 48910, United States

Location

Related Publications (1)

  • 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.

    PMID: 11295888BACKGROUND

Related Links

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Jacek Cholewicki, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

  • Norman P Reeves, PhD

    Michigan State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Walter F. Patenge Professor

Study Record Dates

First Submitted

September 19, 2014

First Posted

October 10, 2014

Study Start

April 1, 2014

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

January 4, 2019

Record last verified: 2019-01

Locations

US(3)