Probiotics for Modic Changes in Low Back Pain Patients
Low Back Pain
About this trial
This is an interventional treatment trial for Low Back Pain
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
Sites / Locations
- Diagnostic Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
probiotic
placebo
Lactobacillus rhamnosis GG
Inactive capsules