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Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain

14. maj 2026 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34093
        • Istanbul University Faculty of Dentistry

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Capsaicin Group
Participants received 0.075% topical capsaicin cream applied four times daily over the temporomandibular joint lateral pole region for 7 days.
Medicin: Capsaicin Topical Cream
Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.
Andre navne:
  • Capsaicin 0.075% Cream
Aktiv komparator: Diclofenac Group
Participants received 1% diclofenac diethylammonium gel applied four times daily over the temporomandibular joint lateral pole region for 7 days.
Medicin: Diclofenac 1% Topical
Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.
Andre navne:
  • Diclofenac Diethylammonium 1% Gel

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in pain intensity measured by Visual Analog Scale (VAS)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Pressure Pain Threshold
Tidsramme: 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
Tidsramme: Baseline, Day 8, and 1 Month
Maximum interincisal mouth opening measured in millimeters.
Baseline, Day 8, and 1 Month
McGill Pain Questionnaire Scores
Tidsramme: Baseline, Day 8, and 1 Month
Pain severity assessed using the McGill Pain Questionnaire.
Baseline, Day 8, and 1 Month
DN4 Neuropathic Pain Scores
Tidsramme: Baseline, Day 8, and 1 Month
Neuropathic pain symptoms assessed using the DN4 questionnaire.
Baseline, Day 8, and 1 Month
Lateral Excursion Measurements
Tidsramme: 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)
Tidsramme: Day 8, and 1 Month
Clinical improvement assessed using the Clinician Global Impression of Change scale.
Day 8, and 1 Month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Istanbul University

Samarbejdspartnere

The Scientific and Technological Research Council of Turkey

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2025

Primær færdiggørelse (Faktiske)

5. april 2026

Studieafslutning (Faktiske)

5. april 2026

Datoer for studieregistrering

Først indsendt

14. maj 2026

Først indsendt, der opfyldte QC-kriterier

14. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 25AKD83

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Temporomandibulære lidelser (TMD)

Kliniske forsøg med Capsaicin Topical Cream

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