Evidence map›Paper›PMID 23404353›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2013

Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy.

Hanne B Albert, Joan S Sorensen, Berit Schiott Christensen, Claus Manniche

4 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 188 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
188citing papers in PubMed, 8 pooled it
36.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03100266 nacompletednot on this mapstarted 2016, after this paper: background citation

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

TypeinterventionalSponsorOle Kudsk JensenRan2016 to 2018Enrolled94ConditionsLow Back PainArmsProbiotic, Inactive capsules
NCT03158766 completednot on this mapstarted 2017, after this paper: background citation

Subclinical Propionibacterium Acnes Infection Estimation in the Intervertebral Disc (SPInE-ID): a Prospective Cohort

TypeobservationalSponsorHospital Israelita Albert EinsteinRan2017 to 2021Enrolled108ConditionsInfection, Intervertebral Disc Herniation, Propionibacterium Infection, Spinal DiseasesArmsMicrodiscectomy
NCT06169488 narecruitingnot on this mapstarted 2024, after this paper: background citation

The Lumbar Interbody Fusion vs. Multidisciplinary Rehabilitation (LIFEHAB) Trial

TypeinterventionalSponsorOslo University HospitalRan2024 to 2030Enrolled202ConditionsChronic Low-back PainArmsLumbar Interbody Fusion, Multidisciplinary rehabilitation
NCT06771492 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

Efficacy of Antibiotic Treatment for Patients With Chronic Low Back Pain and Modic Type I Changes - Randomized Placebo-controlled Trial

TypeinterventionalSponsorBart KoesRan2025 to 2027Enrolled204ConditionsMSK Conditions, Chronic Low Back Pain (CLBP), Modic ChangesArmsAmoxicillin, Placebo
3 · Its place in the literature

Who cites it

188 citing papers in PubMed, 8 syntheses or guidelines pooled it, 383 citations in OpenAlex.

  1. Pooled it
  2. Evidence for infection in intervertebral disc degeneration: a systematic review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2022
    Pooled it
  3. The bacteria-positive proportion in the disc tissue samples from surgery: a systematic review and meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2019
    Pooled it
  4. Pooled it
  5. Do Modic changes have an impact on clinical outcome in lumbar spine surgery? A systematic literature review.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2016
    Pooled it
  6. The location of Modic changes in the lumbar spine: a meta-analysis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2016
    Pooled it
  7. Pathobiology of Modic changes.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2016
    Pooled it
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128 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors at 3 institutions in 1 country.

Hanne B AlbertResearch Department, Spine Centre of Southern Denmark, Institute of Regional Health Services Research, Lillebaelt Hospital, University of Southern Denmark, Middelfart, Denmark. hanne.birgit.albert@slb.regionsyddanmark.dk
Joan S Sorensen
Berit Schiott Christensen
Claus Manniche
University of Southern Denmark · DKAarhus University Hospital · DKLillebaelt Hospital · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeModic type 1 changes/bone edema in the vertebrae are present in 6 % of the general population and 35-40 % of the low back pain population. It is strongly associated with low back pain. The aim was to test the efficacy of antibiotic treatment in patients with chronic low back pain (>6 months) and Modic type 1 changes (bone edema).

methodsThe study was a double-blind RCT with 162 patients whose only known illness was chronic LBP of greater than 6 months duration occurring after a previous disc herniation and who also had bone edema demonstrated as Modic type 1 changes in the vertebrae adjacent to the previous herniation. Patients were randomized to either 100 days of antibiotic treatment (Bioclavid) or placebo and were blindly evaluated at baseline, end of treatment and at 1-year follow-up. OUTCOME MEASURES: Primary outcome, disease-specific disability, lumbar pain. Secondary outcome leg pain, number of hours with pain last 4 weeks, global perceived health, EQ-5D thermometer, days with sick leave, bothersomeness, constant pain, magnetic resonance image (MRI).

results144 of the 162 original patients were evaluated at 1-year follow-up. The two groups were similar at baseline. The antibiotic group improved highly statistically significantly on all outcome measures and improvement continued from 100 days follow-up until 1-year follow-up. At baseline, 100 days follow-up, 1-year follow-up the disease-specific disability-RMDQ changed: antibiotic 15, 11, 5.7; placebo 15, 14, 14. Leg pain: antibiotics 5.3, 3.0, 1.4; placebo 4.0, 4.3, 4.3. Lumbar pain: antibiotics 6.7, 5.0, 3.7; placebo 6.3, 6.3, 6.3. For the outcome measures, where a clinically important effect size was defined, improvements exceeded the thresholds, and a trend towards a dose-response relationship with double dose antibiotics being more efficacious.

conclusionsThe antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.

Indexed as

Lumbar VertebraeAdultAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial AgentsBone DiseasesDisability EvaluationDose-Response Relationship, DrugDouble-Blind MethodEdemaFemaleFollow-Up StudiesHumansIntervertebral Disc DisplacementLow Back PainMaleMiddle AgedAmoxicillin-Potassium Clavulanate CombinationAnti-Bacterial Agents

Identifiers

PMID23404353
PMCPMC3631045
OpenAlexW2156987533

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.