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:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT02268305
Eligibility Criteria:
THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.
Inclusion:
DoD beneficiaries between the ages of 18-65 years old Symptoms of Low Back Pain greater than 12 weeks duration Patients with a history of lower back surgery may be included
Exclusion:
DoD beneficiaries less than 18 years old or greater than 65 years old
Lower back pain caused by any of the following:
Infection Tumor Osteoporosis Ankylosing spondylitis Fracture Deformity Inflammatory process Cauda equina syndrome Treated or untreated central nervous system impairment
Meeting the criteria for surgery, including:
progressive motor deficit sphincter impairment from neurological cause disabling sciatic pain (in the absence of backache) lasting 6 weeks or more that is attributed to a compromised nerve root and demonstrated by magnetic resonance imaging or computed tomography Oncologic disease during the previous 5 years Unexplained weight loss, fever, or chills Diagnosed upper urinary tract infection within last 28 days Patients identified during standard of care interview to have a history of intravenous drug use.
Immunocompromised host
A severe comorbidity to include:
determining overall well-being (e.g. painful disabling arthritic hip joints) Cirrhosis Ongoing dialysis Radiating symptoms to lower extremities (sciatica) History of bleeding disorders History of high blood pressure History of heart, kidney, liver or ulcer disease Allergic to analgesics or Non-steroidal anti inflammatory agents (NSAIDs) Pregnant or breastfeeding Initial pain rating of greater than 8/10 on initial intake evaluation If any of the components of the comprehensive metabolic panel are outside the Nellis clinical laboratory reference ranges, the subject will be excluded from the study
If any of these four components of the complete blood count are outside of the Nellis clinical laboratory reference ranges, the subject will be excluded from the study:
White blood cell count Hemoglobin Hematocrit Platelets
Patients taking any of the following medications are excluded from participating, unless they agree to wash out for two weeks prior to entering the study:
Muscle relaxers of any type Non-steroidal anti-inflammatory agents (NSAIDs) \* Patients taking naproxen must agree to wash out for two weeks prior to entering the study, but can begin taking it again, as prescribed, after Visit 1 where a baseline pain assessment is performed.
Tramadol Gabapentin Pregabalin Glucosamine Narcotic pain medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02268305
Study Brief:
Protocol Section:
NCT02268305