Two Botulinum Toxin A Injections in Patients With Chronic Orofacial Myalgia: A Randomised, Double-Blind, Controlled Multicenter Trial With Nine-Month Follow-Up.

IF 4 3区医学 Q1 DENTISTRY, ORAL SURGERY & MEDICINE

Journal of oral rehabilitation Pub Date : 2025-08-06 DOI:10.1111/joor.70032

Christine Lennartsson, Ellie Saghafi, Behnosh Öhrnell Malekzadeh, Per Alstergren, Birgitta Johansson Cahlin

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引用次数: 0

Abstract

Background: Conventional treatment for reducing pain is not always successful in patients with chronic orofacial myalgia.

Objective: The objective of this study was to investigate the pain-reducing efficacy of two botulinum toxin A injections in patients with chronic orofacial myalgia who had already received conservative treatment.

Methods: The patients included were 18 years or older and diagnosed with myalgia according to the Diagnostic Criteria for Temporomandibular Disorders. Their pain had persisted for more than six months in spite of previous conservative treatment. The design was a randomised, double-blind, placebo-controlled, multicenter, parallel group study. Participants received two injections of botulinum toxin A or saline at an interval of three months. Follow-up visits were conducted at one, three, four, six and nine months after the first injection.

Results: Seventy-two patients were enrolled and sixty-nine completed the study. Between baseline and all follow-up visits, there was a significant decrease in VAS pain intensity for both groups, but the difference between groups was not significant.

Conclusion: The use of botulinum toxin A in managing chronic orofacial myalgia did not offer any additional pain relief compared with saline at any of the follow-up occasions.

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两种A型肉毒毒素注射治疗慢性口面肌痛：一项随机、双盲、多中心对照试验，随访9个月。

背景：慢性口面肌痛患者的常规镇痛治疗并不总是成功的。目的：探讨两种A型肉毒杆菌毒素注射对已接受保守治疗的慢性口面肌痛患者的镇痛效果。方法：纳入的患者年龄在18岁及以上，根据《颞下颌疾病诊断标准》诊断为肌痛。尽管之前进行过保守治疗，但他们的疼痛持续了6个多月。设计为随机、双盲、安慰剂对照、多中心、平行组研究。参与者每隔三个月注射两次肉毒毒素A或生理盐水。在第一次注射后1、3、4、6和9个月进行随访。结果：72例患者入组，69例完成研究。在基线和所有随访期间，两组VAS疼痛强度均显著降低，但组间差异不显著。结论：与生理盐水相比，在任何随访场合，肉毒杆菌毒素A在治疗慢性口面部肌痛时都没有提供任何额外的疼痛缓解。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of oral rehabilitation 医学-牙科与口腔外科

CiteScore

5.60

自引率

10.30%

发文量

116

审稿时长

4-8 weeks

期刊介绍： Journal of Oral Rehabilitation aims to be the most prestigious journal of dental research within all aspects of oral rehabilitation and applied oral physiology. It covers all diagnostic and clinical management aspects necessary to re-establish a subjective and objective harmonious oral function. Oral rehabilitation may become necessary as a result of developmental or acquired disturbances in the orofacial region, orofacial traumas, or a variety of dental and oral diseases (primarily dental caries and periodontal diseases) and orofacial pain conditions. As such, oral rehabilitation in the twenty-first century is a matter of skilful diagnosis and minimal, appropriate intervention, the nature of which is intimately linked to a profound knowledge of oral physiology, oral biology, and dental and oral pathology. The scientific content of the journal therefore strives to reflect the best of evidence-based clinical dentistry. Modern clinical management should be based on solid scientific evidence gathered about diagnostic procedures and the properties and efficacy of the chosen intervention (e.g. material science, biological, toxicological, pharmacological or psychological aspects). The content of the journal also reflects documentation of the possible side-effects of rehabilitation, and includes prognostic perspectives of the treatment modalities chosen.