Lumbar Modic changes
Conditions
Interventions
Bifidobacteria-treated group:Two capsules of live Bifidobacterium bifidum containing 5 billion Bifidobacterium bifidum per capsule were given every 12 hours for a treatment period of 3 months,
placebo group:In the placebo group: two capsules of placebo (Bifidobacterium bifidum cofactor) were given orally every 12 hours for a treatment period of 3 months.
Sponsors
The First People’s Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years; 2. Presence of modic change (the height of the lesion range >= 10% of the vertebral body height and the diameter is > for 5 mm), including MC type I, MC type II and MC1/2 mixed type, as demonstrated by magnetic resonance examination; 3. Presence of moderate functional impairment (Chinese translation of the Roland-Morris Functional Impairment Questionnaire >5); 4. No active immune response (C-reactive protein).
Exclusion criteria
Exclusion criteria: 1. Pregnant or in lactation; 2. Allergy to live bifidobacteria; 3. Allergy to any of the therapeutic drugs in this trial; 4. A history of antibiotic treatment for more than two weeks within the past 3 months with acid-suppressing drugs, bismuth, tannins, medicinal charcoal, and tinctures; 5. A history of probiotic treatment within 3 months; 6. Have a habit of consuming probiotic foods or medications; 7. Have used hormone drugs; 8. Having any specific diagnosis that can explain the patient's low back pain symptoms (e.g. tumour, fracture, spinal arthritis, infection, spinal deformity, lumbar spondylolisthesis and spinal stenosis); 9. A history of lumbar segmental spine surgery (L1-S1, fusion, decompression and disc prosthesis implantation, etc.); 10. Indication of lumbar segment spinal surgery and plan to perform the surgery; 11. Autoimmune disease, immunodeficiency, taking immunosuppressive drugs; 12. Malignant tumour, hypertension, poorly controlled diabetes mellitus, severe neurological diseases, psychiatric disorders and other serious diseases; hepatic, renal or cardiac dysfunction; severe intestinal diseases; confirmed lactose intolerance; 13. Contraindications to MRI (metal implants, such as pacemakers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| simplified Chinese Roland-Morris Disability Questionnaire (SCRMDQ); | — |
Secondary
| Measure | Time frame |
|---|---|
| MRI;Oswestry disability index;Bone Density Test;depression-anxiety-stress-21;16S rRNA PCR amplification Illumina sequencing and targeted metabolite analysis of faecal flora and metabolite changes in patients at 3 months post treatment;Patient satisfaction;Use of analgesic drugs;numerical rating scale scores for lower back and legs; | — |
Countries
China
Contacts
Public ContactJiayu Chen
Department of Orthopedics, The First People’s Hospital of Yunnan Province
Outcome results
None listed