Probiotics for Modic Changes in Low Back Pain Patients

NCT03100266 | Completed

• 1 other identifier: 1-10-72-308-15
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• Change in disability (Roland Morris (0-23)) during the first year

  1 year

Secondary Outcomes (10)

• Proportion with minimal loss of function at 1 year (Roland Morris <4).

  1 year

• Change in the back + leg pain during the first year.

  1 year

• Change in disability and pain level during the first 102 days.

  102 days

• Change in disability and pain level from 102 days to 1 year

  102 days to one year

• Global effect after 1 year according to participant, measured by a 7-point Likert scale.

  1 year

Study Arms (2)

probiotic

EXPERIMENTAL

Lactobacillus rhamnosis GG

Dietary Supplement: Probiotic

placebo

PLACEBO COMPARATOR

Inactive capsules

Other: Inactive capsules

Interventions

Probiotic DIETARY_SUPPLEMENT

Lactobacillus rhamonosus GG

probiotic

Inactive capsules OTHER

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Back pain must dominate leg pain
• Pain duration \>3 months and relevant disability (RM\>5)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ole Kudsk Jensen: lead
• The Danish Rheumatism Association: collaborator

Study Sites (1)

Diagnostic Center

Silkeborg, 8600, Denmark

Location

Related Publications (37)

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MeSH Terms

Conditions

Low Back Pain

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Ole Kudsk Jensen, MD

  Hospitalsenhed Midt, Region Midtjylland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant, ph.d.

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 4, 2017
• Study Start: January 14, 2016
• Primary Completion: April 7, 2018
• Study Completion: April 7, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

DK (1)