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- Ensayo clínico NCT07598994
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
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Istanbul
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Istanbul, Istanbul, Turquía (Türkiye), 34093
- Istanbul University Faculty of Dentistry
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
Otros nombres:
|
|
Comparador activo: 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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in pain intensity measured by Visual Analog Scale (VAS)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pressure Pain Threshold
Periodo de tiempo: 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
Periodo de tiempo: Baseline, Day 8, and 1 Month
|
Maximum interincisal mouth opening measured in millimeters.
|
Baseline, Day 8, and 1 Month
|
|
McGill Pain Questionnaire Scores
Periodo de tiempo: Baseline, Day 8, and 1 Month
|
Pain severity assessed using the McGill Pain Questionnaire.
|
Baseline, Day 8, and 1 Month
|
|
DN4 Neuropathic Pain Scores
Periodo de tiempo: Baseline, Day 8, and 1 Month
|
Neuropathic pain symptoms assessed using the DN4 questionnaire.
|
Baseline, Day 8, and 1 Month
|
|
Lateral Excursion Measurements
Periodo de tiempo: 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)
Periodo de tiempo: Day 8, and 1 Month
|
Clinical improvement assessed using the Clinician Global Impression of Change scale.
|
Day 8, and 1 Month
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Enfermedades Estomatognáticas
- Enfermedades Musculares
- Enfermedades Articulares
- Enfermedades de la mandíbula
- Enfermedades mandibulares
- Trastornos Craneomandibulares
- Trastornos de la articulación temporomandibular
- Químicos orgánicos
- Compuestos heterocíclicos
- Preparaciones farmacéuticas
- Ácidos grasos
- Lípidos
- Formas de dosificación
- Álcenos
- Hidrocarburos, acíclico
- Hidrocarburos
- Hidrocarburos, cíclico
- Ácidos carboxílicos
- Alcaloides
- Hidrocarburos, aromáticos
- Amidas
- Catecols
- Fenoles
- Derivados de benceno
- Mezclas complejas
- Ácidos, carbocíclicos
- Ácidos grasos, insaturados
- Coloides
- Fenilacetatos
- Alcaloides solanáceos
- Alkamidas poliinsaturadas
- Ácidos grasos, monoinsaturados
- Diclofenaco
- Capsaicina
- dietilamina de diclofenaco
- Geles
Otros números de identificación del estudio
- 25AKD83
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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