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
Results First Received: October 17, 2013  
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
Condition: Low Back Pain
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 455 participants were recruited from the Dallas-Fort Worth, Texas metroplex from August 2006 to September 2010 through newspaper advertisements, community agencies, and medical clinics, excluding OMT specialty clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were randomized after their study eligibility was confirmed by both telephonic and clinical screening examinations.

Reporting Groups
  Description
OMT + UST Active osteopathic manipulation and active ultrasound physical therapy
Sham OMT + UST Sham osteopathic manipulation and active ultrasound physical therapy
OMT + Sham UST Active osteopathic manipulation and sham ultrasound physical therapy
Sham OMT + Sham UST Sham osteopathic manipulation and sham ultrasound physical therapy

Participant Flow:   Overall Study
    OMT + UST     Sham OMT + UST     OMT + Sham UST     Sham OMT + Sham UST  
STARTED     115     118     115     107  
COMPLETED     115     118     115     107  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
OMT + UST Active osteopathic manipulation and active ultrasound physical therapy
Sham OMT + UST Sham osteopathic manipulation and active ultrasound physical therapy
OMT + Sham UST Active osteopathic manipulation and sham ultrasound physical therapy
Sham OMT + Sham UST Sham osteopathic manipulation and sham ultrasound physical therapy
Total Total of all reporting groups

Baseline Measures
    OMT + UST     Sham OMT + UST     OMT + Sham UST     Sham OMT + Sham UST     Total  
Number of Participants  
[units: participants]
  115     118     115     107     455  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     111     117     112     105     445  
>=65 years     4     1     3     2     10  
Age  
[units: years]
Mean (Standard Deviation)
  40.50  (13.05)     39.19  (11.90)     41.97  (12.58)     41.38  (12.99)     40.74  (12.63)  
Gender  
[units: participants]
         
Female     66     68     78     72     284  
Male     49     50     37     35     171  
Region of Enrollment  
[units: participants]
         
United States     115     118     115     107     455  



  Outcome Measures
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1.  Primary:   Change in Visual Analogue Scale Score for Pain Over 12 Weeks (OMT vs Sham OMT)   [ Time Frame: 12 weeks ]

2.  Primary:   Change in Visual Analogue Scale Score for Pain Over 12 Weeks (Active UST vs Sham UST)   [ Time Frame: 12 weeks ]

3.  Secondary:   Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 4)   [ Time Frame: 4 weeks ]

4.  Secondary:   Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 8)   [ Time Frame: 8 weeks ]

5.  Secondary:   Roland Morris Disability Questionnaire (OMT and Sham OMT - Week 12)   [ Time Frame: 12 weeks ]

6.  Secondary:   Roland Morris Disability Questionnaire (UST and Sham UST - Week 4)   [ Time Frame: 4 weeks ]

7.  Secondary:   Roland Morris Disability Questionnaire (UST and Sham UST - Week 8)   [ Time Frame: 8 weeks ]

8.  Secondary:   Roland Morris Disability Questionnaire (UST and Sham UST - Week 12)   [ Time Frame: 12 weeks ]

9.  Secondary:   Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 4)   [ Time Frame: 4 weeks ]

10.  Secondary:   Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 8)   [ Time Frame: 8 weeks ]

11.  Secondary:   Medical Outcomes Study SF-36 Health Survey (OMT and Sham OMT - Week 12)   [ Time Frame: 12 weeks ]

12.  Secondary:   Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 4)   [ Time Frame: 4 Weeks ]

13.  Secondary:   Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 8)   [ Time Frame: 8 Weeks ]

14.  Secondary:   Medical Outcomes Study SF-36 Health Survey (UST and Sham UST - Week 12)   [ Time Frame: 12 Weeks ]

15.  Secondary:   Work Disability (OMT and Sham OMT - Week 4)   [ Time Frame: 4 weeks ]

16.  Secondary:   Work Disability (OMT and Sham OMT - Week 8)   [ Time Frame: 8 weeks ]

17.  Secondary:   Work Disability (OMT and Sham OMT - Week 12)   [ Time Frame: 12 weeks ]

18.  Secondary:   Work Disability (UST and Sham UST - Week 4)   [ Time Frame: 4 weeks ]

19.  Secondary:   Work Disability (UST and Sham UST - Week 8)   [ Time Frame: 8 weeks ]

20.  Secondary:   Work Disability (UST and Sham UST - Week 12)   [ Time Frame: 12 weeks ]

21.  Secondary:   Satisfaction With Back Care (OMT and Sham OMT - Week 4)   [ Time Frame: 4 weeks ]

22.  Secondary:   Satisfaction With Back Care (OMT and Sham OMT - Week 8)   [ Time Frame: 8 weeks ]

23.  Secondary:   Satisfaction With Back Care (OMT and Sham OMT - Week 12)   [ Time Frame: 12 weeks ]

24.  Secondary:   Satisfaction With Back Care (UST and Sham UST - Week 4)   [ Time Frame: 4 weeks ]

25.  Secondary:   Satisfaction With Back Care (UST and Sham UST - Week 8)   [ Time Frame: 8 weeks ]

26.  Secondary:   Satisfaction With Back Care (UST and Sham UST - Week 12)   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Co-morbid conditions, work disability and low back pain co-treatments were self reported by participants, but were not verified through medical or employment records. Missing data were imputed for 13% of participants at the final encounter.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: John C. Licciardone, DO, MS, MBA
Organization: University of North Texas Health Science Center-The Osteopathic Research Center
phone: 817-735-2028
e-mail: john.licciardone@unthsc.edu


Publications of Results:

Other 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., University of North Texas Health Science Center
ClinicalTrials.gov Identifier: NCT00315120     History of Changes
Other Study ID Numbers: 06-02-20-1
K24AT002422 ( US NIH Grant/Contract Award Number )
Study First Received: April 13, 2006
Results First Received: October 17, 2013
Last Updated: May 24, 2016
Health Authority: United States: Institutional Review Board