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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
Sponsor:
Collaborator:
The Danish Rheumatism Association
Information provided by (Responsible Party):
Ole Kudsk Jensen, Regionshospitalet Silkeborg

Brief Summary:

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 [5]. 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 [7]. In addition, more inflammatory cells have been identified in this type of structural abnormality [25]. 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 [6]. 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 [16]. 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

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: probiotic
Lactobacillus rhamnosis GG
Dietary Supplement: Probiotic
Lactobacillus rhamonosus GG

Placebo Comparator: placebo
Inactive capsules
Other: Inactive capsules
Placebo




Primary Outcome Measures :
  1. Change in disability (Roland Morris (0-23)) during the first year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Proportion with minimal loss of function at 1 year (Roland Morris <4). [ Time Frame: 1 year ]
  2. Change in the back + leg pain during the first year. [ Time Frame: 1 year ]
  3. Change in disability and pain level during the first 102 days. [ Time Frame: 102 days ]
  4. Change in disability and pain level from 102 days to 1 year [ Time Frame: 102 days to one year ]
  5. Global effect after 1 year according to participant, measured by a 7-point Likert scale. [ Time Frame: 1 year ]
  6. Proportion of patients on sick leave at baseline working again after 1 year. [ Time Frame: 1 year ]
  7. Number of patients referred for surgical evaluation and number operated. [ Time Frame: 1 year ]
  8. Changes in IL-6, IL-1 0 and TNF-alpha during the first (14 days, 102 days and 1 year). [ Time Frame: 1 year ]
  9. Change of type 1 Modic on magnetic resonance imaging during the first year. [ Time Frame: 1 year ]
  10. Change in volume of type 1 Modic during the first year. [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Locations
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Denmark
Diagnostic Center
Silkeborg, Denmark, 8600
Sponsors and Collaborators
Ole Kudsk Jensen
The Danish Rheumatism Association
Investigators
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Principal Investigator: Ole Kudsk Jensen, MD Hospitalsenhed Midt, Region Midtjylland
Publications:

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Responsible Party: Ole Kudsk Jensen, Consultant, ph.d., Regionshospitalet Silkeborg
ClinicalTrials.gov Identifier: NCT03100266    
Other Study ID Numbers: 1-10-72-308-15
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms