The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain Trial

This study has been completed.
Sponsor:
Collaborators:
Osteopathic Heritage Foundations
Information provided by:
University of North Texas Health Science Center
ClinicalTrials.gov Identifier:
NCT00315120
First received: April 13, 2006
Last updated: May 9, 2011
Last verified: May 2011

April 13, 2006
May 9, 2011
August 2006
January 2011   (final data collection date for primary outcome measure)
Visual analogue scale score for pain [ Time Frame: 1, 2, 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Medical Outcomes Study SF-36 Health Survey [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Work disability [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
  • Satisfaction with back care [ Time Frame: 4, 8, 12 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
The OSTEOPATHIC Trial: The OSTEOPAThic Health Outcomes In Chronic Low Back Pain 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.

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: Active osteopathic manipulation and active ultrasound physical therapy
    Active osteopathic manipulation and active ultrasound physical therapy
  • Procedure: Sham osteopathic manipulation and active ultrasound physical therapy
    Sham osteopathic manipulation and active ultrasound physical therapy
  • Procedure: Active osteopathic manipulation and sham ultrasound physical therapy
    Active osteopathic manipulation and sham ultrasound physical therapy
  • Procedure: Sham osteopathic manipulation and sham ultrasound physical therapy
    Sham osteopathic manipulation and sham ultrasound physical therapy
  • A
    Active osteopathic manipulation and active ultrasound physical therapy
    Intervention: Procedure: Active osteopathic manipulation and active ultrasound physical therapy
  • B
    Sham osteopathic manipulation and active ultrasound physical therapy
    Intervention: Procedure: Sham osteopathic manipulation and active ultrasound physical therapy
  • C
    Active osteopathic manipulation and sham ultrasound physical therapy
    Intervention: Procedure: Active osteopathic manipulation and sham ultrasound physical therapy
  • D
    Sham osteopathic manipulation and sham ultrasound physical therapy
    Intervention: Procedure: Sham osteopathic manipulation and sham ultrasound physical therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
488
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
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00315120
06-02-20-1, NIH grant no.: K24 AT002422
Yes
John C. Licciardone, D.O., M.S., M.B.A., The Osteopathic Research Center
University of North Texas Health Science Center
  • National Institutes of Health (NIH)
  • Osteopathic Heritage Foundations
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 2011

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