Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain
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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
Istanbul
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Istanbul、Istanbul、トルコ（Türkiye）、34093
- Istanbul University Faculty of Dentistry
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Capsaicin Group
Participants received 0.075% topical capsaicin cream applied four times daily over the temporomandibular joint lateral pole region for 7 days.
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Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.
他の名前：
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アクティブコンパレータ：Diclofenac Group
Participants received 1% diclofenac diethylammonium gel applied four times daily over the temporomandibular joint lateral pole region for 7 days.
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Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in pain intensity measured by Visual Analog Scale (VAS)
時間枠：Baseline, Day 8, and 1 Month
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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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pressure Pain Threshold
時間枠：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
時間枠：Baseline, Day 8, and 1 Month
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Maximum interincisal mouth opening measured in millimeters.
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Baseline, Day 8, and 1 Month
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McGill Pain Questionnaire Scores
時間枠：Baseline, Day 8, and 1 Month
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Pain severity assessed using the McGill Pain Questionnaire.
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Baseline, Day 8, and 1 Month
|
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DN4 Neuropathic Pain Scores
時間枠：Baseline, Day 8, and 1 Month
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Neuropathic pain symptoms assessed using the DN4 questionnaire.
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Baseline, Day 8, and 1 Month
|
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Lateral Excursion Measurements
時間枠：Baseline, Day 8, and 1 Month
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Right and left mandibular lateral excursion movements measured in millimeters.
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Baseline, Day 8, and 1 Month
|
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Clinician Global Impression of Change (CGIC)
時間枠：Day 8, and 1 Month
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Clinical improvement assessed using the Clinician Global Impression of Change scale.
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Day 8, and 1 Month
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Craft RM, Mogil JS, Aloisi AM. Sex differences in pain and analgesia: the role of gonadal hormones. Eur J Pain. 2004 Oct;8(5):397-411. doi: 10.1016/j.ejpain.2004.01.003.
- Busse JW, Casassus R, Carrasco-Labra A, Durham J, Mock D, Zakrzewska JM, Palmer C, Samer CF, Coen M, Guevremont B, Hoppe T, Guyatt GH, Crandon HN, Yao L, Sadeghirad B, Vandvik PO, Siemieniuk RAC, Lytvyn L, Hunskaar BS, Agoritsas T. Management of chronic pain associated with temporomandibular disorders: a clinical practice guideline. BMJ. 2023 Dec 15;383:e076227. doi: 10.1136/bmj-2023-076227.
- Mena M, Dalbah L, Levi L, Padilla M, Enciso R. Efficacy of topical interventions for temporomandibular disorders compared to placebo or control therapy: a systematic review with meta-analysis. J Dent Anesth Pain Med. 2020 Dec;20(6):337-356. doi: 10.17245/jdapm.2020.20.6.337. Epub 2020 Dec 28.
- Haanpaa M, Treede RD. Capsaicin for neuropathic pain: linking traditional medicine and molecular biology. Eur Neurol. 2012;68(5):264-75. doi: 10.1159/000339944. Epub 2012 Sep 28.
- Klinge SA, Sawyer GA. Effectiveness and safety of topical versus oral nonsteroidal anti-inflammatory drugs: a comprehensive review. Phys Sportsmed. 2013 May;41(2):64-74. doi: 10.3810/psm.2013.05.2016.
- Alomar X, Medrano J, Cabratosa J, Clavero JA, Lorente M, Serra I, Monill JM, Salvador A. Anatomy of the temporomandibular joint. Semin Ultrasound CT MR. 2007 Jun;28(3):170-83. doi: 10.1053/j.sult.2007.02.002.
- Gan TJ. Diclofenac: an update on its mechanism of action and safety profile. Curr Med Res Opin. 2010 Jul;26(7):1715-31. doi: 10.1185/03007995.2010.486301.
- Harper DE, Schrepf A, Clauw DJ. Pain Mechanisms and Centralized Pain in Temporomandibular Disorders. J Dent Res. 2016 Sep;95(10):1102-8. doi: 10.1177/0022034516657070. Epub 2016 Jun 28.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 25AKD83
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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