Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT02054650
Eligibility Criteria:
Inclusion Criteria:
1. Fasting plasma glucose ≥126 mg/dL; OR
2. Oral glucose tolerance test ≥200 mg/dL; OR
3. HbA1c ≥6.5%
AND
4. Low back pain on most days for past three months; AND
5. Usual low back pain severity of 4 or greater on an 11 point numerical scale during the past week.
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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT02054650
Study Brief:
Protocol Section:
NCT02054650