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 @ 4:23 AM
Ignite Modification Date:
2025-12-25 @ 4:23 AM
NCT ID:
NCT03101020
Eligibility Criteria:
Inclusion Criteria:
* primary complaint of chronic non-specific low back pain (more than 12 weeks);
* pain symptoms in the low back with a score ≥ 2/10 on the 0-10 Numerical Pain Rating Scale (12);
* aged 18-80;
* history of surgery in the abdominopelvic region for more than 6 months;
* history of visceral dysfunction (e.g., constipation and reflux); and
* no known or suspected serious spinal pathology (e.g., metastasis, inflammatory or infective diseases of the spine, causa equine syndrome, canal stenosis, spinal fracture).
Exclusion Criteria:
* no nerve root compromise evidenced by at least two of the following: (1) myotomal weakness, (2) dermatomal or widespread sensory loss, (3) hyporeflexia or hyperreflexia of the lower limb reflexes;
* no spinal surgery within the preceding 6 months;
* no vascular abnormality such as abdominal aortic aneurysms;
* not currently receiving chiropractic, osteopathic or other physical therapy;
* not pregnant or suspect being pregnant;
* not currently in an acute inflammatory phase of known gastrointestinal or urinary diseases (such as cholecystitis, renal calculi, peritonitis, appendicitis);
* not currently taking medications that significantly alter gut motility;
* not currently taking medications (such as oral corticosteroids) which are known to increase the risk of intestinal perforation);
* no known gastrointestinal disease that associates with a risk of intestinal perforation (e.g. Chron's disease, diverticular disease, peptic ulcer disease);
* not taking anti-platelet medications such as warfarin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03101020
Study Brief:
Protocol Section:
NCT03101020