Topical Capsaicin Versus Diclofenac for Chronic Temporomandibular Joint-Related Pain

NCT07598994 | Completed

• 1 other identifier: 25AKD83
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Temporomandibular Disorders (TMD); Temporomandibular Pain

Keywords

Capsaicin; Diclofenac; Temporomandibular Disorders; Topical Treatment

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity measured by Visual Analog Scale (VAS)

  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

Secondary Outcomes (6)

• Pressure Pain Threshold

  Baseline, Day 8, and 1 Month

• Maximum Mouth Opening

  Baseline, Day 8, and 1 Month

• McGill Pain Questionnaire Scores

  Baseline, Day 8, and 1 Month

• DN4 Neuropathic Pain Scores

  Baseline, Day 8, and 1 Month

• Lateral Excursion Measurements

  Baseline, Day 8, and 1 Month

Study Arms (2)

Capsaicin Group

EXPERIMENTAL

Participants received 0.075% topical capsaicin cream applied four times daily over the temporomandibular joint lateral pole region for 7 days.

Drug: Capsaicin Topical Cream

Diclofenac Group

ACTIVE COMPARATOR

Participants received 1% diclofenac diethylammonium gel applied four times daily over the temporomandibular joint lateral pole region for 7 days.

Drug: Diclofenac 1% Topical

Interventions

Capsaicin Topical Cream DRUG

Topical capsaicin cream applied four times daily over the temporomandibular joint region for 7 days.

Also known as: Capsaicin 0.075% Cream

Capsaicin Group

Diclofenac 1% Topical DRUG

Topical diclofenac diethylammonium gel applied four times daily over the temporomandibular joint region for 7 days.

Also known as: Diclofenac Diethylammonium 1% Gel

Diclofenac Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istanbul University Faculty of Dentistry

Istanbul, Istanbul, 34093, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 33409363 BACKGROUND

• 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.

  PMID: 23037991 BACKGROUND

• 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.

  PMID: 23703519 BACKGROUND

• 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.

  PMID: 17571700 BACKGROUND

• 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.

  PMID: 20470236 BACKGROUND

• 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.

  PMID: 15324772 BACKGROUND

• 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.

  PMID: 27422858 BACKGROUND

• 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.

  PMID: 38101929 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Capsaicin; Diclofenac; diclofenac diethylamine; Gels

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were blinded to treatment allocation during the study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Participants were randomly assigned to one of two parallel treatment groups receiving either topical capsaicin cream or topical diclofenac diethylammonium gel for temporomandibular joint-related pain.

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start: August 28, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

TU (1)