Osteopathic Health Outcomes in Chronic Low Back Pain (OSTEOPATHIC) Trial
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Intervention: A. Active OMT and active UST; B. Sham OMT and active UST; C. Active OMT and sham UST; D. Sham OMT and sham UST
Intervention description: Active osteopathic manipulation (OMT) and active ultrasound physical therapy (UST); Sham osteopathic manipulation (OMT) and active ultrasound physical therapy (UST); Active osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST); Sham osteopathic manipulation (OMT) and sham ultrasound physical therapy (UST)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 455.0
Sex: All
Minimum age: 21 Years
Maximum age: 69 Years
Healthy volunteers: No
Keywords: Randomized controlled trial; Low back pain; Spinal manipulative therapy; Spinal manipulation; Osteopathic manipulation; Osteopathic medicine; Physical therapy modalities

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 effective in the treatment of chronic low back pain.
    

Eligibility 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