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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
  Purpose
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.

Condition Intervention Phase
Low Back Pain
Procedure: A. Active OMT and active UST
Procedure: B. Sham OMT and active UST
Procedure: C. Active OMT and sham UST
Procedure: D. Sham OMT and sham UST
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Osteopathic Manipulative Treatment and Ultrasound Physical Therapy for Chronic Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of North Texas Health Science Center:

Primary Outcome Measures:
  • 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%).


Secondary Outcome Measures:
  • 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


Enrollment: 455
Study Start Date: August 2006
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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)
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)
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)

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.
  Eligibility

Ages Eligible for Study:   21 Years to 69 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00315120

Locations
United States, Texas
The Osteopathic Research Center
Fort Worth, Texas, United States, 76107
Sponsors and Collaborators
University of North Texas Health Science Center
National Institutes of Health (NIH)
Osteopathic Heritage Foundations
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: John C. Licciardone, DO, MS, MBA The Osteopathic Research Center, University of North Texas Health Science Center at Fort Worth
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John C. Licciardone, D.O., M.S., M.B.A., Director, Osteopathic Research Center, University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT00315120     History of Changes
Other Study ID Numbers: 06-02-20-1  K24AT002422 
Study First Received: April 13, 2006
Results First Received: October 17, 2013
Last Updated: May 24, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of North Texas Health Science Center:
Randomized controlled trial
Low back pain
Spinal manipulative therapy
Spinal manipulation
Osteopathic manipulation
Osteopathic medicine
Physical therapy modalities

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 29, 2016