Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain
报名条件（概要）
- 年龄：18 Years – 60 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Pakistan
药品与企业信息
Participants will receive a total dose of 100 units of Botulinum Toxin Type A (BoNT-A) administered by intramuscular injection into the bilateral masseter and temporalis muscles (25 U per side in each muscle). The injections will be performed using a 31G × 12 mm needle. Participants will be followed at 1 week, 1 month, and 3 months to assess pain intensity and maximal interincisal mouth opening.
Participants will receive 0.9% normal saline by intramuscular injection into the bilateral masseter and temporalis muscles using the same injection technique, volume, and follow-up schedule as the experimental group. The placebo is used to maintain blinding and serve as the comparator.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain who have not improved after at least 3 months of conservative treatment. Eligible patients aged 18-60 years will be randomly assigned to one of two groups: * Intervention group: Intramuscular injection of 100 U BoNT-A into the bilateral masseter and temporalis muscles. * Control group: Intramuscular injection of 0.9% normal saline (placebo) using the same technique. The primary outcomes will be: * Pain intensity, measured using a 0-10 pain scale (VAS/NRS). * Maximum mouth opening (maximal interincisal distance), measured in millimetres. Assessments will be performed before treatment (baseline) and at 1 week, 1 month, and 3 months after injection. The study will also monitor adverse events associated with the injections. The aim is to determine whether BoNT-A provides greater pain relief and improved mouth opening compared with placebo in patients with temporomandibular myofascial pain. The findings may help support the use of BoNT-A as a treatment option for patients who do not respond to conventional therapy and provide valuable evidence for clinical practice in Pakista
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Muhammad Sohaib Arshadmuhammadsohaibarshad542@gmail.com+923345635938
研究中心联系方式
- Islamic International Dental HospitalIslamabad，Pakistan
问自己是否符合条件、如何预筛
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain ClinicalTrials.gov Identifier: NCT07847541 Sponsor: Riphah International University Investigational product: Botulinum Toxin Type A (BoNT-A), 0.9% Normal Saline (Placebo) About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain 试验编号：NCT07847541 申办方：Riphah International University 研究药物：Botulinum Toxin Type A (BoNT-A)、0.9% Normal Saline (Placebo) 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。