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 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
NCT ID:
NCT03100266
Eligibility Criteria:
Inclusion criteriae
Referral to one of the two spine centres in Central Denmark Region (Silkeborg and Aarhus)
Sufficient competency in Danish to fill out questionnaires
Age between 18 and 65 years, both included
MRI verified type 1 Modic changes within the last 3 months, either exclusively, mixed or in combination with type 2 or type 3 changes
No sign of activation of the immune system at inclusion (normal CRP)
Back pain must dominate leg pain
Pain duration \>3 months and relevant disability (RM\>5)
Exclusion criteriae
On beforehand, plans of or a wish for spinal surgery
Spinal surgery for disc herniation or spinal stenosis within the last 6 months
Previous spinal fusion surgery
Plans of treatment with antibiotics for Modic changes elsewhere
Antibiotic treatment for Modic changes within the preceding ½ year
More than two weeks of antibiotic treatment within the past three months
Immunosuppressive treatment at present
Lacking ability to enter or complete the project due to either mental, social or geographical reasons
Known intestinal pathology, autoimmune disease, immune deficiency, malabsorption, cancer or chronic infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03100266
Study Brief:
Protocol Section:
NCT03100266