- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Istanbul
-
Istanbul, Istanbul, Turkiet (Türkiye), 34093
- Istanbul University Faculty of Dentistry
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
|
Aktiv komparator: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in pain intensity measured by Visual Analog Scale (VAS)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pressure Pain Threshold
Tidsram: 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
Tidsram: Baseline, Day 8, and 1 Month
|
Maximum interincisal mouth opening measured in millimeters.
|
Baseline, Day 8, and 1 Month
|
|
McGill Pain Questionnaire Scores
Tidsram: Baseline, Day 8, and 1 Month
|
Pain severity assessed using the McGill Pain Questionnaire.
|
Baseline, Day 8, and 1 Month
|
|
DN4 Neuropathic Pain Scores
Tidsram: Baseline, Day 8, and 1 Month
|
Neuropathic pain symptoms assessed using the DN4 questionnaire.
|
Baseline, Day 8, and 1 Month
|
|
Lateral Excursion Measurements
Tidsram: 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)
Tidsram: Day 8, and 1 Month
|
Clinical improvement assessed using the Clinician Global Impression of Change scale.
|
Day 8, and 1 Month
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Muskuloskeletala sjukdomar
- Stomatogena sjukdomar
- Muskelsjukdomar
- Ledsjukdomar
- Käksjukdomar
- Mandibular sjukdomar
- Kraniomandibulära sjukdomar
- Temporomandibulära ledstörningar
- Organiska kemikalier
- Heterocykliska föreningar
- Farmaceutiska förberedelser
- Fettsyror
- Lipider
- Doseringsformer
- Alkener
- Kolväten, acyklisk
- Kolväten
- Kolväten, cykliska
- Karboxylsyror
- Alkaloider
- Kolväten, aromatisk
- Amider
- Katekoler
- Fenoler
- Bensiverivat
- Komplexa blandningar
- Syror, karbocyklisk
- Fettsyror, omättade
- Kolloid
- Fenylacetater
- Solanhaltiga alkaloider
- Fleromättade alkamider
- Fettsyror, enomättad
- Diklofenak
- Capsaicin
- diklofenak dietylamin
- Geler
Andra studie-ID-nummer
- 25AKD83
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