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Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain

2026年6月29日 更新者:Yesim Eren、Istanbul University

Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain: A Randomized, Prospective, Single-Blind Clinical Trial

The goal of this clinical trial is to compare the effectiveness and safety of topical capsaicin cream and topical diclofenac gel in women with chronic temporomandibular joint-related pain. The main questions it aims to answer are:

  • Does topical capsaicin reduce pain intensity more effectively than topical diclofenac?
  • Do the treatments improve jaw function, pressure pain threshold, and neuropathic pain symptoms?

Researchers will compare topical capsaicin cream with topical diclofenac gel to evaluate differences in pain relief and functional improvement.

Participants will:

  • Apply the assigned topical medication four times daily for 7 days
  • Attend clinical examinations and pain assessments at baseline, Day 8, and Month 1
  • Complete pain-related questionnaires and functional jaw measurements during follow-up visits

研究概览

详细说明

This randomized prospective single-blind clinical trial was designed to evaluate the efficacy and safety of topical capsaicin cream compared with topical diclofenac diethylammonium gel in female patients with chronic temporomandibular joint-related pain. Fifty women aged between 18 and 65 years diagnosed with temporomandibular disorders were randomly assigned to either the capsaicin group or the diclofenac group.

Participants in the capsaicin group applied 0.075% topical capsaicin cream, while participants in the diclofenac group applied 1% diclofenac diethylammonium gel. Both medications were applied four times daily over the temporomandibular joint lateral pole region for 7 days. Existing occlusal splint therapy was continued throughout the study period.

Clinical evaluations were performed at baseline, Day 8, and Month 1. Outcome measures included pain intensity assessed with a visual analog scale, multidimensional pain assessment using the McGill Pain Questionnaire, neuropathic pain evaluation using the DN4 questionnaire, pressure pain threshold measurements, maximum mouth opening, lateral mandibular movements, clinician global impression of change, and adverse effects.

The study was approved by the Istanbul University Faculty of Dentistry Clinical Research Ethics Committee and conducted in accordance with the Declaration of Helsinki.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Istanbul
      • Istanbul、Istanbul、土耳其(türkiye)、34093
        • Istanbul University Faculty of Dentistry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Female participants aged between 18 and 65 years
  • Diagnosis of temporomandibular disorder (TMD)-related pain
  • Presence of pain for at least 3 months
  • Baseline pain intensity sufficient to require treatment
  • Willingness to comply with study procedures and follow-up visits
  • Signed informed consent form

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • History of allergy or hypersensitivity to capsaicin or diclofenac
  • Presence of systemic inflammatory or neurological disease
  • Use of systemic analgesics, corticosteroids, or muscle relaxants during the study period
  • Active skin lesions or dermatologic disease in the application area
  • Previous temporomandibular joint surgery
  • Participation in another clinical trial within the last 30 days
  • Inability to comply with study procedures

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Capsaicin Group
Participants received 0.075% topical capsaicin cream applied four times daily over the temporomandibular joint lateral pole region for 7 days.
Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.
其他名称:
  • Capsaicin 0.075% Cream
有源比较器:Diclofenac Group
Participants received 1% diclofenac diethylammonium gel applied four times daily over the temporomandibular joint lateral pole region for 7 days.
Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.
其他名称:
  • Diclofenac Diethylammonium 1% Gel

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in pain intensity measured by Visual Analog Scale (VAS)
大体时间:Baseline, Day 8, and 1 Month
Pain intensity was evaluated using a 10-cm Visual Analog Scale (VAS) in patients with temporomandibular disorder-related pain. Changes in VAS scores were compared between the capsaicin and diclofenac
Baseline, Day 8, and 1 Month

次要结果测量

结果测量
措施说明
大体时间
Pressure Pain Threshold
大体时间:Baseline, Day 8, and 1 Month
Pressure pain threshold over the temporomandibular joint lateral pole measured using a dolorimeter.
Baseline, Day 8, and 1 Month
Maximum Mouth Opening
大体时间:Baseline, Day 8, and 1 Month
Maximum interincisal mouth opening measured in millimeters.
Baseline, Day 8, and 1 Month
McGill Pain Questionnaire Scores
大体时间:Baseline, Day 8, and 1 Month
Pain severity assessed using the McGill Pain Questionnaire.
Baseline, Day 8, and 1 Month
DN4 Neuropathic Pain Scores
大体时间:Baseline, Day 8, and 1 Month
Neuropathic pain symptoms assessed using the DN4 questionnaire.
Baseline, Day 8, and 1 Month
Lateral Excursion Measurements
大体时间:Baseline, Day 8, and 1 Month
Right and left mandibular lateral excursion movements measured in millimeters.
Baseline, Day 8, and 1 Month
Clinician Global Impression of Change (CGIC)
大体时间:Day 8, and 1 Month
Clinical improvement assessed using the Clinician Global Impression of Change scale.
Day 8, and 1 Month

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年8月28日

初级完成 (实际的)

2026年4月6日

研究完成 (实际的)

2026年4月6日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月29日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

The decision regarding individual participant data sharing has not yet been finalized.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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