Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial

May 24, 2016 updated by: John C. Licciardone, D.O., M.S., M.B.A., University of North Texas Health Science Center

A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. This study uses a 2X2 factorial design to test the hypotheses.

Study Type

Interventional

Enrollment (Actual)

455

Phase

  • Phase 3

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
    • Texas
      • Fort Worth, Texas, United States, 76107
        • The Osteopathic Research Center

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 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must give a positive response to the question: "Have you had low back pain constantly or on most days for the last three months?"
  • Must identify the low back as the primary site of pain
  • Must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy
  • Women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required)

Exclusion Criteria:

  • History of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome
  • History of surgery involving the low back within the past year or planned low back surgery in the future
  • History of receiving Workers' Compensation benefits within the past three months
  • Involvement in current litigation relating to back problems
  • Current pregnancy or plan to become pregnant during the course of participation in the study
  • Any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year
  • Any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy
  • Use of intravenous, intramuscular, or oral corticosteroids within the past month
  • History of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year
  • Practitioner or student of any of the following: osteopathic medicine (D.O.) allopathic medicine (M.D.), chiropractic (D.C.), physical therapy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A (Active OMT and active (UST)
Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy
Procedure: A. Active OMT and active UST
Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
Other: B (Sham OMT and active UST)
Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy
Procedure: B. Sham OMT and active UST
Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
Other: C (Active OMT and sham UST)
Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy
Procedure: C. Active OMT and sham UST
Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
Other: D (Sham OMT and sham UST)
Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy
Procedure: D. Sham OMT and sham UST
Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)
Time Frame: 12 weeks
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
12 weeks
Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)
Time Frame: 12 weeks
Comparison of the number (proportion) of participants in each study group who achieve a substantial improvement in low back pain over 12 weeks as determined by at least a 40-mm reduction (-40 mm) on the visual analogue scale score for pain compared with the baseline score. Changes in the visual analogue scale scores for pain over 12 weeks may potentially range from a 100-mm reduction (-100 mm) to a 100-mm increase (+100). Any reduction (negative score) represents an improvement in low back pain (i.e., a "better" outcome), while any increase (positive score) represents a worsening of low back pain (i.e., a "worse" outcome). However, only those "better" outcomes represented by change scores less than or equal to -40 mm are considered to represent substantial improvement in low back pain, which is the primary outcome measure of this study. For analyses wherein floor effects are important, the 40-mm reduction threshold for substantial improvement may be replaced by 50% reduction (-50%).
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)
Time Frame: 4 weeks
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
4 weeks
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)
Time Frame: 8 weeks
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
8 weeks
Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)
Time Frame: 12 weeks
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
12 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)
Time Frame: 4 weeks
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
4 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)
Time Frame: 8 weeks
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
8 weeks
Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)
Time Frame: 12 weeks
Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
12 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)
Time Frame: 4 weeks
The general health scale ranges from 0 to 100, with higher scores representing better general health.
4 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)
Time Frame: 8 weeks
The general health scale ranges from 0 to 100, with higher scores representing better general health.
8 weeks
Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)
Time Frame: 12 weeks
The general health scale ranges from 0 to 100, with higher scores representing better general health.
12 weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)
Time Frame: 4 Weeks
The general health scale ranges from 0 to 100, with higher scores representing better general health.
4 Weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)
Time Frame: 8 Weeks
The general health scale ranges from 0 to 100, with higher scores representing better general health.
8 Weeks
Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)
Time Frame: 12 Weeks
The general health scale ranges from 0 to 100, with higher scores representing better general health.
12 Weeks
Work Disability (OMT and Sham OMT - Week 4)
Time Frame: 4 weeks
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
4 weeks
Work Disability (OMT and Sham OMT - Week 8)
Time Frame: 8 weeks
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
8 weeks
Work Disability (OMT and Sham OMT - Week 12)
Time Frame: 12 weeks
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
12 weeks
Work Disability (UST and Sham UST - Week 4)
Time Frame: 4 weeks
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
4 weeks
Work Disability (UST and Sham UST - Week 8)
Time Frame: 8 weeks
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
8 weeks
Work Disability (UST and Sham UST - Week 12)
Time Frame: 12 weeks
Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
12 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 4)
Time Frame: 4 weeks
Subjects who reported being very satisfied with back care
4 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 8)
Time Frame: 8 weeks
Subjects who reported being very satisfied with back care
8 weeks
Satisfaction With Back Care (OMT and Sham OMT - Week 12)
Time Frame: 12 weeks
Subjects who reported being very satisfied with back care
12 weeks
Satisfaction With Back Care (UST and Sham UST - Week 4)
Time Frame: 4 weeks
Subjects who reported being very satisfied with back care
4 weeks
Satisfaction With Back Care (UST and Sham UST - Week 8)
Time Frame: 8 weeks
Subjects who reported being very satisfied with back care
8 weeks
Satisfaction With Back Care (UST and Sham UST - Week 12)
Time Frame: 12 weeks
Subjects who reported being very satisfied with back care
12 weeks

Collaborators and Investigators

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

Sponsor

University of North Texas Health Science Center

Collaborators

National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Osteopathic Heritage Foundations

Investigators

  • Principal Investigator: John C. Licciardone, DO, MS, MBA, The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth

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

August 1, 2006

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

April 13, 2006

First Submitted That Met QC Criteria

April 13, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

May 24, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-02-20-1
  • K24AT002422 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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