Evidence map›Paper›PMID 28645291›Full record

Trial reportBMC musculoskeletal disorders2017

The effect of zoledronic acid on type and volume of Modic changes among patients with low back pain.

Katri Koivisto, Jyri Järvinen, Jaro Karppinen, Marianne Haapea, Markus Paananen, Eero Kyllönen, Osmo Tervonen, Jaakko Niinimäki

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC musculoskeletal disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01330238 (Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.5field-weighted citation impact, top 19% 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.

NCT01330238 phase2completednot on this map

Phase 2 Study of the Efficacy of Zoledronic Acid in Low Back Pain Related to Vertebral Endplate Signal Changes, the So-called Modic Changes

TypeinterventionalSponsorUniversity of OuluRan2008 to 2012Enrolled40ConditionsLow Back PainArmsZoledronic acid vs. placebo
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 19 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Serum biomarkers for Modic changes in patients with chronic low back pain.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 · 2021
    Article
  8. Article
  9. Article
  10. Article
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Katri KoivistoMedical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.ORCID http://orcid.org/0000-0001-7329-7886
Jyri JärvinenInstitute of Diagnostics, Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.
Jaro KarppinenMedical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland. jaro.karppinen@ttl.fi.
Marianne HaapeaMedical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
Markus PaananenMedical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
Eero KyllönenMedical Research Center Oulu, Oulu University Hospital and University of Oulu, Oulu, Finland.
Osmo TervonenInstitute of Diagnostics, Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.
Jaakko NiinimäkiInstitute of Diagnostics, Department of Diagnostic Radiology, Oulu University Hospital, Oulu, Finland.
Oulu University Hospital · FI

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundModic changes (MC) are associated with low back pain (LBP). In this study, we compared changes in size and type of MC, after a single intravenous infusion of 5 mg zoledronic acid (ZA) or placebo, among chronic LBP patients with MC on magnetic resonance imaging (MRI), and evaluated whether the MRI changes correlate with symptoms.

methodsAll patients (N = 19 in ZA, 20 in placebo) had MRI at baseline (0.23-1.5 T) and at one year (1.5-3 T). We evaluated the level, type and volume of all the MC. The MC were classified into M1 (M1 (100%)), predominating M1 (M1/2 (65:35%)) or predominating M2 (M1/2 (35:65%)), and M2 (M2 (100%)). The first two were considered M1-dominant, and the latter two M2-dominant. Volumes of M1 and M2 were calculated separately for the primary MC, which was assumed to cause the symptoms, and the other MC. We analysed the one-year treatment differences in M1 and M2 volumes using analysis of covariance with adjustments for age, sex, body mass index, and smoking. The correlations between the MRI changes and the changes in LBP symptoms were analysed using Pearson correlations.

resultsIn the ZA group, 84.2% of patients had M1-dominant primary MC at baseline, compared to 50% in the placebo group (p = 0.041). The primary MC in the ZA group converted more likely to M2-dominant (42.1% ZA, 15% placebo; p = 0.0119). The other MC (15 ZA, 8 placebo) were on average 42% smaller and remained largely M2-dominant. The M1 volume of the primary MC decreased in the ZA group, but increased in the placebo group (-0.83 cm

conclusionsZoledronic acid tended to speed up the conversion of M1-dominant into M2-dominant MC and decrease the volume of M1-dominant MC, although statistical significance was not demonstrated.

trial registrationThe registration number in ClinicalTrials.gov is NCT01330238 and the date of registration February 11, 2011.

Indexed as

AdultBone Density Conservation AgentsDiphosphonatesFemaleHumansImidazolesLow Back PainMagnetic Resonance ImagingMaleMiddle AgedSpineZoledronic AcidBone Density Conservation AgentsDiphosphonatesImidazolesZoledronic AcidLow back painMagnetic resonance imagingModic changesRandomized trialType of Modic changesZoledronic acid

Identifiers

PMID28645291
PMCPMC5481864
OpenAlexW2701911415

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.