Status:
COMPLETED
Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
Lead Sponsor:
University of North Texas Health Science Center
Collaborating Sponsors:
National Institutes of Health (NIH)
Osteopathic Heritage Foundations
Conditions:
Low Back Pain
Eligibility:
All Genders
21-69 years
Phase:
PHASE3
Brief Summary
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 effectiv...
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 effectiv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
455 Patients enrolled
Trial Details
Trial ID
NCT00315120
Start Date
August 1 2006
End Date
January 1 2011
Last Update
July 6 2016
Active Locations (1)
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1
The Osteopathic Research Center
Fort Worth, Texas, United States, 76107