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临床试验/NCT07847541
NCT07847541招募中2 期

Clinical Evaluation of Botulinum Toxin a in the Management of Temporomandibular Myofascial Pain

Riphah International University1 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2026年8月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
118
试验地点
1
主要终点
Pain Intensity Numerical Rating Scale

研究概览

简要总结

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

详细描述

Temporomandibular disorders (TMDs) are a group of musculoskeletal and joint issues that affect the temporomandibular joint (TMJ), masticatory muscles, and associated structures. Common patient presentations that can significantly affect quality of life include pain, joint sounds, limited mouth opening, headaches, earaches, and functional impairment (1,2). The multiple causes of TMD, which include parafunctional habits like bruxism, internal derangements, trauma, and myofascial dysfunction, make diagnosis and therapy challenging (3,4).

Physical therapy, occlusal splints, muscle relaxants, and nonsteroidal anti-inflammatory drugs (NSAIDs) remain the primary line of conservative treatment (4). However, some patients with myofascial pain do not react well to conventional therapeutic methods, necessitating other approaches (5). The neurotoxin botulinum toxin type A (BoNT-A) blocks the release of acetylcholine at the neuromuscular junction, resulting in muscle relaxation and temporary chemodenervation (6). Numerous clinical studies have demonstrated that BoNT-A improves jaw function, reduces the intensity of discomfort, and increases maximal interincisal distance in individuals with myofascial TMD (5-7). Even though there is noticeable pain relief, other trials show differing degrees of improvement in mouth opening, therefore the evidence is still inconclusive (6,7).

Given these disagreements, more randomized controlled trials (RCTs) are required to establish consistent treatment recommendations regarding dosage, injection sites, and follow-up schedules. The lack of local data from Pakistan about the use of BoNT-A in TMD therapy emphasizes the need for population-specific evidence.

Objectives:

To evaluate the effectiveness of botulinum toxin type A (BoNT-A) in patients with temporomandibular myofascial pain, by assessing changes in pain intensity and maximal interincisal distance compared with placebo.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
治疗
盲法
双盲 (受试者、研究者)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • History of TMD, no relief with conservative therapy after at least three months.
  • Clinical diagnosis of bilateral arthrogenous disorder and myalgia.
  • Moreover, TMD can be confirmed by diagnosis through MRI and CT examinations
  • Pregnancy or lactation.
  • Previous mandible or significant facial trauma.
  • History of prior TMD treatment or cosmetic treatments of the face with BoNT/A.
  • Any contraindication to BoNT/A as outlined in the XEOMIN package insert.

排除标准

  • 未提供

研究组 & 干预措施

Botulinum Toxin Type A (BoNT-A)

Experimental

干预措施: Botulinum Toxin Type A (BoNT-A) (Drug)

Placebo (0.9% Normal Saline)

Placebo Comparator

干预措施: 0.9% Normal Saline (Placebo) (Drug)

结局指标

主要结局

Pain Intensity Numerical Rating Scale

时间窗: 1 week, 1 month, and 3 months after injection.

Changes in pain intensity can be measured using various scales, such as the 11-point Pain Intensity Numerical Rating Scale (PI-NRS), where 0=no pain and 10=worst possible pain. The PI-NRS is commonly used to assess pain intensity in chronic pain management. However, interpreting the clinical importance of changes from baseline on this scale can be challenging. Studies have estimated a clinically important difference on the PI-NRS by relating it to global assessments of change in multiple studies of chronic pain.

Change in maximal interincisal mouth opening (MIO)

时间窗: 1 week, 1 month, and 3 months after injection.

The maximum interincisal distance (MID) is a crucial measurement for assessing the function of the temporomandibular joint (TMJ) and the masticatory muscles. It is measured by the distance between the upper and lower incisors when the mouth is fully opened. This measurement is particularly important in evaluating TMJ disorders and can indicate the health of the jaw and its associated muscles.

次要结局

  • Incidence of adverse events(hroughout the 3-month follow-up period.)
  • Pain during mandibular movements(1 week, 1 month, and 3 months.)

研究者

申办方类型
其他
责任方
申办方

研究点 (1)

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标识符

NCT 编号
NCT07847541
其他研究编号
IIDC/IRC/2025/11/005

日期

首次提交
(上个月)
首次发布
(昨天)
主要完成日期
(2个月后)
研究完成日期
(2个月后)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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