Evidence map›Paper›PMID 29961037›Full record

ArticleBMJ open2018

Intra-articular botulinum toxin A for base-of-thumb osteoarthritis: protocol for a randomised trial (RHIBOT).

Charlotte Gil, Hendy Abdoul, Raphaël Campagna, Henri Guerini, Estelle Ieong, Franck Chagny, Catherine Bedin, Alexandra Roren, Marie-Martine Lefèvre-Colau, Serge Poiraudeau and 3 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03187626 (Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 41% 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.

NCT03187626 phase2 / phase3completednot on this map

Short-term Efficacy of a Single Ultrasound-guided Intra-articular Injection of Botulinum Toxin A Associated With Splinting for Base-of-thumb Osteoarthritis: a Randomized Controlled Double-blind Pilot Study

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2018 to 2021Enrolled60ConditionsBase-of-thumb OsteoarthritisArmsbotulinum toxin A, saline
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Article
  3. 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

13 authors at 4 institutions in 1 country.

Charlotte GilAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Hendy AbdoulUnité de Recherche Clinique - Centre d'Investigation Clinique Paris Descartes Necker/Cochin, Hôpital Tarnier, Paris, France.
Raphaël CampagnaAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Radiologie B, Paris, France.
Henri GueriniAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Radiologie B, Paris, France.
Estelle IeongAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Franck ChagnyAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Catherine BedinAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Alexandra RorenAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Marie-Martine Lefèvre-ColauAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Serge PoiraudeauAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Antoine FeydyAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Radiologie B, Paris, France.
François RannouAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Christelle NguyenAP-HP, Hôpitaux Universitaires Paris Centre-Groupe Hospitalier Cochin, Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Paris, France.
Assistance Publique – Hôpitaux de Paris · FRGroupe Hospitalier Cochin - Port-Royal, Hôtel-Dieu, Broca - La Collégiale · FRUniversité Paris Cité · FRSorbonne Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRecent studies have suggested that intra-articular injection of botulinum toxin A (BTA) may have analgesic effects in degenerative joint diseases. We aim to assess the efficacy of intra-articular injection of BTA associated with splinting in patients with trapeziometacarpal osteoarthritis (TMC OA). METHODS AND ANALYSIS: We will conduct a randomised double-blind controlled trial. Overall, 60 individuals with TMC OA fulfilling adapted 1990 American College of Rheumatology criteria for hand OA will be recruited in one tertiary care centre in France and randomised to receive splinting + a single ultrasound-guided injection in the TMC joint of 50 Allergan Units of BTA resuspended in 1 mL saline or splinting +1 mL saline. Randomisation will be centralised. The allocation ratio will be 1:1. The primary outcome will be the mean change from baseline in base-of-thumb pain on a self-administered 11-point Numeric Rating Scale in 10-point increments at 3 months after injection. Secondary outcomes will be the mean change in base-of-thumb pain at 1 and 6 months, mean change in hand-specific activity limitations assessed by the self-administered Cochin Hand Function Scale, proportion of responders assessed by the Osteoarthritis Research Society International -Outcome Measures in Rheumatology (OMERACT) criteria and consumption of analgesics and non-steroidal anti-inflammatory drugs assessed by a self-administered 4-class scale at 3 and 6 months. Cointerventions will be allowed in both groups and will be self-reported. Adverse events will be recorded at 3 and 6 months. Participants, care providers and statisticians will be blinded to the allocated treatment. ETHICS AND DISSEMINATION: The RHIBOT trial has been authorised by the Agence Nationale de Sécurité du Médicament and approved by the Comité de Protection des Personnes de Tours Ouest-1. The findings of the study will be disseminated in peer-reviewed journals and at conferences. If the results are positive, intra-articular BTA could be an efficient and safe complementary therapeutic option for patients with TMC OA. DATE AND VERSION IDENTIFIER OF THE PROTOCOL: 8 January 2018, V. 2.0. TRIAL REGISTRATION NUMBER: NCT03187626; Pre-results.

Indexed as

Randomized Controlled Trials as TopicBotulinum Toxins, Type ADouble-Blind MethodHumansInjections, Intra-ArticularNeuromuscular AgentsOsteoarthritisPain MeasurementProspective StudiesThumbTreatment OutcomeBotulinum Toxins, Type ANeuromuscular Agentsbotulinum toxin Aintra-articular treatmentrandomised trialtrapeziometacarpal osteoarthritis

Identifiers

PMID29961037
PMCPMC6042589
OpenAlexW2810827827

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.