Evidence map›Paper›PMID 29141611›Full record

Trial reportBMC musculoskeletal disorders2017

Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial.

Mélanie Cogné, Hervé Petit, Alexandre Creuzé, Dominique Liguoro, Mathieu de Seze

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 2 registered trials, which are not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.4field-weighted citation impact, top 34% 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.

NCT00437762 phase3completednot on this map

Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2007 to 2012Enrolled61ConditionsTennis ElbowArmsBotulinum Toxin A Injection, Placebo injection
NCT03181802 phase3completednot on this map

Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?

TypeinterventionalSponsorUniversity Hospital, BordeauxRan2003 to 2005Enrolled19ConditionsChronic Low-back PainArmsBotox, Placebos
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Review
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

5 authors at 3 institutions in 1 country.

Mélanie CognéService de Médecine Physique et de Réadaptation, hôpital Raymond Poincaré, 92380, Garches, France. melaniecogne@hotmail.fr.
Hervé PetitService de Médecine Physique et de Réadaptation, CHU de Bordeaux, 33076, Bordeaux, France.
Alexandre CreuzéService de Médecine Physique et de Réadaptation, CHU de Bordeaux, 33076, Bordeaux, France.
Dominique LiguoroNeurosurgical Unit, University Hospital, Bordeaux, France.
Mathieu de SezeService de Médecine Physique et de Réadaptation, CHU de Bordeaux, 33076, Bordeaux, France.
Centre Hospitalier Universitaire de Bordeaux · FRBordeaux Population Health · FRHôpital Raymond-Poincaré · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTreatment for patients with chronic low-back pain (LBP) is a public health issue. Intramuscular injections of botulinum toxin A (BoNT-A) have shown an analgesic effect on LBP in two previous randomized controlled studies. The objective of the study was to verify the efficacy of paravertebral injections of BoNT-A in patients with LBP.

methodsPatients were included in this phase 3 randomized double-blinded trial comparing the efficacy of BoNT-A versus placebo in a crossover study on LBP. Both groups received 200 units of BoNT-A in paravertebral muscles or a placebo, and vice versa at Day 120. The main judgment criterion was LBP intensity 1 month after the injections, evaluated by using a visual pain scale (VAS). Secondary assessment criteria included: LBP intensity 90 and 120 days after injection day; number of days when an allowed antalgic oral treatment was needed in between each evaluation; functional disability measured by the Quebec Back Pain Disability Scale; quality of life; inability to work; patient satisfaction in relation to the treatment's effect; spinal mobility; and strength of spinal muscles, measured by isokinetic technique.

resultsNineteen patients completed the study. There was no significant difference between the groups' average LBP during the last 8 days at Day30 (p = 0.97). There was no significant difference between the two groups regarding the secondary assessment criteria (p > 0.05).

conclusionsInjections of BoNT-A in the paravertebral muscles were not found to be effective to relieve chronic LBP. The limits of the study are that the dose of BoNT-A used was lower than in other studies, and that the limited number of patients included may explain the negative results. TRIAL REGISTRATIONS: Identifiers: NCT03181802 . Unique Protocol ID: CHUBX2003.

Indexed as

AdultBotulinum Toxins, Type ACross-Over StudiesDouble-Blind MethodFemaleHumansInjections, IntramuscularLow Back PainMaleMiddle AgedMuscle StrengthNeuromuscular AgentsQuality of LifeTreatment OutcomeBotulinum Toxins, Type ANeuromuscular AgentsBotulinum toxinDisabilityFunctionLow-back painQuality of lifeWork

Identifiers

PMID29141611
PMCPMC5688690
OpenAlexW2770367956

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.