Probiotics for Modic Changes in Low Back Pain Patients
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|ClinicalTrials.gov Identifier: NCT03100266|
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : November 14, 2018
Probiotics for spinal inflammatory end-plate changes, so-called Modic changes, a randomised controlled study
Modic changes are inflammatory end-plate changes primarily affecting the lower lumbar levels. They are associated with disc degeneration, disc herniation and age, and are only seen on magnetic resonance imaging of the lumbar spine, not on X-ray. Three different types of Modic changes have been described, type 1, 2 and 3, the latter being rare . It has been shown that type 1, but not type 2, is associated with more intense low back pain (LBP) and worse LBP outcome including a lower rate of return to work . In addition, more inflammatory cells have been identified in this type of structural abnormality . Modic changes may affect up to 20% of the general population and more than the double proportion in clinical populations, type 1 and 2 being about equally represented . The investigators have estimated that at least 5,000 of the patients, who are referred to secondary health care in Denmark for LBP per year, will suffer from type 1 Modic changes.
Based on a hypothesis of infection as the cause of Modic changes, a randomised clinical trial with one year follow-up has been performed . This trial documented significant effect of long-term (100 days) broad-spectrum antibiotic treatment (amoxicillin/ clavulanic acid) in patients with type 1 Modic changes. However, infection in Modic changes has not been documented convincingly in this or in other studies, and almost all of the treatment effect occurred after the antibiotic treatment was stopped. As yet, the study has not been replicated. The investigators hypothesize that the treatment effect may have been caused by an effect on the gut microbiom possibly explaining the delay of the effect.
Probiotics have been shown to influence interleukins in patients with inflammatory conditions and in healthy volunteers [32, 36, 37].
The investigators are therefore performing a randomised trial to study the clinical effect of probiotics on type 1 Modic changes as well as the effect on interleukin levels. The trial is designed as a randomised, clinical, double blind, placebo-controlled trial taking place at the Spine Center, Silkeborg Regional Hospital. Power calculation was based on a smaller treatment effect than the effect found in the study above and resulted in the requirement of including 94 patients. One-year follow-up is planned.
The investigators use lactobacillus rhamnosus GG (Dicoflor®) for the trial, as this strain has been used in several clinical studies. The dietary supplement has been shown to influence relevant interleukins significantly, and it has been proven to be stable in action and safe, also in pregnancy.
A positive result of such a trial may have significant consequences. The perspective of using probiotics instead of antibiotics in this common disorder is very attractive. At the time being, many type 1 Modic patients in Denmark and other western countries are treated with antibiotics. This is of great concern because of side effects and possible drug resistance development of bacteria.
The Technology Transfer Office of Aarhus University is involved.
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Dietary Supplement: Probiotic Other: Inactive capsules||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Probiotics for Modic Changes: a Randomised Controlled Study to Elucidate the Effect of Probiotics on Vertebral Inflammatory End-plate Changes, So-called Type 1 Modic Changes|
|Actual Study Start Date :||January 14, 2016|
|Actual Primary Completion Date :||April 7, 2018|
|Actual Study Completion Date :||April 7, 2018|
Lactobacillus rhamnosis GG
Dietary Supplement: Probiotic
Lactobacillus rhamonosus GG
Placebo Comparator: placebo
Other: Inactive capsules
- Change in disability (Roland Morris (0-23)) during the first year [ Time Frame: 1 year ]
- Proportion with minimal loss of function at 1 year (Roland Morris <4). [ Time Frame: 1 year ]
- Change in the back + leg pain during the first year. [ Time Frame: 1 year ]
- Change in disability and pain level during the first 102 days. [ Time Frame: 102 days ]
- Change in disability and pain level from 102 days to 1 year [ Time Frame: 102 days to one year ]
- Global effect after 1 year according to participant, measured by a 7-point Likert scale. [ Time Frame: 1 year ]
- Proportion of patients on sick leave at baseline working again after 1 year. [ Time Frame: 1 year ]
- Number of patients referred for surgical evaluation and number operated. [ Time Frame: 1 year ]
- Changes in IL-6, IL-1 0 and TNF-alpha during the first (14 days, 102 days and 1 year). [ Time Frame: 1 year ]
- Change of type 1 Modic on magnetic resonance imaging during the first year. [ Time Frame: 1 year ]
- Change in volume of type 1 Modic during the first year. [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100266
|Silkeborg, Denmark, 8600|
|Principal Investigator:||Ole Kudsk Jensen, MD||Hospitalsenhed Midt, Region Midtjylland|