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

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Osteopathic Heritage Foundations
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
John C. Licciardone, D.O., M.S., M.B.A., University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT00315120
First received: April 13, 2006
Last updated: May 24, 2016
Last verified: May 2016

April 13, 2006
May 24, 2016
August 2006
January 2011   (final data collection date for primary outcome measure)
  • Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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%).
  • Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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%).
  • Visual analogue scale for pain
  • Roland-Morris Disability Questionnaire
  • Medical Outcomes Study SF-36 Health Survey
  • Work disability
  • Satisfaction with back care
Complete list of historical versions of study NCT00315120 on ClinicalTrials.gov Archive Site
  • Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
  • Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
  • Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
  • Roland Morris Disability Questionnaire (UST and Sham UST - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
  • Roland Morris Disability Questionnaire (UST and Sham UST - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
  • Roland Morris Disability Questionnaire (UST and Sham UST - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Overall scores range from 0 to 24, which higher scores representing greater deficits in back-specific functioning.
  • Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The general health scale ranges from 0 to 100, with higher scores representing better general health.
  • Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    The general health scale ranges from 0 to 100, with higher scores representing better general health.
  • Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    The general health scale ranges from 0 to 100, with higher scores representing better general health.
  • Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4) [ Time Frame: 4 Weeks ] [ Designated as safety issue: No ]
    The general health scale ranges from 0 to 100, with higher scores representing better general health.
  • Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8) [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
    The general health scale ranges from 0 to 100, with higher scores representing better general health.
  • Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
    The general health scale ranges from 0 to 100, with higher scores representing better general health.
  • Work Disability (OMT and Sham OMT - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
  • Work Disability (OMT and Sham OMT - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
  • Work Disability (OMT and Sham OMT - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
  • Work Disability (UST and Sham UST - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
  • Work Disability (UST and Sham UST - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
  • Work Disability (UST and Sham UST - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants who reported losing one or more work days in the past 4 weeks because of low back pain.
  • Satisfaction With Back Care (OMT and Sham OMT - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects who reported being very satisfied with back care
  • Satisfaction With Back Care (OMT and Sham OMT - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Subjects who reported being very satisfied with back care
  • Satisfaction With Back Care (OMT and Sham OMT - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Subjects who reported being very satisfied with back care
  • Satisfaction With Back Care (UST and Sham UST - Week 4) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Subjects who reported being very satisfied with back care
  • Satisfaction With Back Care (UST and Sham UST - Week 8) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Subjects who reported being very satisfied with back care
  • Satisfaction With Back Care (UST and Sham UST - Week 12) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Subjects who reported being very satisfied with back care
Not Provided
Not Provided
Not Provided
 
Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
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.
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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • Procedure: A. Active OMT and active UST
    Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
  • Procedure: B. Sham OMT and active UST
    Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST)
  • Procedure: C. Active OMT and sham UST
    Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
  • Procedure: D. Sham OMT and sham UST
    Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
  • A (Active OMT and active (UST)
    Subjects in this group received active osteopathic manipulation and active ultrasound physical therapy
    Intervention: Procedure: A. Active OMT and active UST
  • B (Sham OMT and active UST)
    Subjects in this group received sham osteopathic manipulation and active ultrasound physical therapy
    Intervention: Procedure: B. Sham OMT and active UST
  • C (Active OMT and sham UST)
    Subjects in this group received active osteopathic manipulation and sham ultrasound physical therapy
    Intervention: Procedure: C. Active OMT and sham UST
  • D (Sham OMT and sham UST)
    Subjects in this group received sham osteopathic manipulation and sham ultrasound physical therapy
    Intervention: Procedure: D. Sham OMT and sham UST

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
455
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 69 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315120
06-02-20-1, K24AT002422
Yes
No
Not Provided
John C. Licciardone, D.O., M.S., M.B.A., University of North Texas Health Science Center
University of North Texas Health Science Center
  • National Institutes of Health (NIH)
  • Osteopathic Heritage Foundations
  • National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: John C. Licciardone, DO, MS, MBA The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth
University of North Texas Health Science Center
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP