OMT of Somatic Dysfunction and Chronic Low Back Pain in Patients With Type 2 Diabetes Mellitus

Exclusion Criteria

• •1. age less than 18 years or age greater than 79 years; OR
• •2. having a previous or current diagnosis of type 1 diabetes mellitus; OR
• •3. having a history of any of the following pancreatic or related disorders: (a) acute or chronic pancreatitis, (b) pancreatic tumor or cancer, (c) Zollinger-Ellison syndrome, or (d) any other medical or surgical condition resulting in functional hypo- or hyperglycemia; OR
• •4. having end-stage renal disease; OR
• •5. having a history of any surgery involving the pancreas; OR
• •6. having a history of low back surgery in the past year; OR
• •7. receiving workers' compensation benefits in the past three months; OR
• •8. having involvement in ongoing litigation relating to diabetes mellitus or back problems; OR
• •9. having a history of a stroke or transient ischemic attack in the past year; OR
• •10. having used intravenous, intramuscular or oral corticosteroids within the past month; OR
• •11. attending a manual treatment session (OMT or any manual therapies delivered by chiropractors or physical therapists) in the past three months, or more than three times in the past year; OR
• •12. practicing osteopathic medicine, chiropractic, or physical therapy, or attending a corresponding professional school; OR
• •13. being pregnant; OR
• •14. currently participating in another medical research study
• •Subjects will also be excluded if any of the following conditions are found during the clinical screening:
• •1. presence of "red flag" conditions relating to LBP (cancer at any anatomical site, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, or cauda equina syndrome); OR
• •2. angina or congestive heart failure symptoms with minimal activity; OR
• •3. active bleeding or infection in the lower back, or any other condition that might impede protocol implementation; OR
• •4. discovery of the presence of any telephone screening exclusion criterion (EXCEPT that the usual LBP severity over the past week may have declined from ≥4/10 points to ≥3/10 points during the lag time between screenings).