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Effect of Amitriptyline Cream on Muscle and Joint Pain

Effect of Base Cream with 5% Amitriptyline on Orofacial Pain: Muscle and Joint

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6dpzvty
Enrollment
Unknown
Registered
2023-06-19
Start date
2023-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

This study will be a single-blind, randomized controlled clinical trial with two arms and a parallel intervention. Volunteers will not know which drug will be administered. They will be divided into 2
D02.241.223.601.210

Sponsors

Faculdade de Odontologia de Piracicaba- Universidade Estadual de Campinas
Lead Sponsor
Faculdade de Odontologia de Piracicaba- Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age equal to or greater than 18 years; Undergraduate and postgraduate students at the Piracicaba School of Dentistry; Complaint of persistent facial and/or joint pain (TMJ) present for at least 3 months that corresponds to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) (Pereira and Gonçalves, 2020; Schiffman, 2014). The diagnostic nomenclature of Axis I and Axis II of DC/TMD will be used; Having accepted and signed the Informed Consent Form

Exclusion criteria

Exclusion criteria: Under 18 years old; Present other pain syndromes; Refusal to adhere to treatment using topical drugs; Report an allergy to any component of the formula; Make use of antidepressant, anticonvulsant and anti-inflammatory; Be under the direct supervision of the researchers (developing some type of activity in undergraduate and postgraduate courses

Design outcomes

Primary

MeasureTime frame
We hope that the tricyclic antidepressant (Amitriptyline 5%) in topical form, when associated with Pentravan® base cream, will have a modulating effect on pain related to temporomandibular disorders. In order to be able to correctly evaluate the intended parameters, the Visual Analog Scale (VAS), verbal scale to assess the quality of pain, face scales and pressure test with ALMEMO® 2450 instrument will be used. distance measured between point 0 and the demarcation made by the volunteer will be the intensity of pain expressed in numerical value; The verbal scale will be analyzed according to the patients' statement, using phrases that represent different subjective pain intensities, such as no pain, mild pain, moderate pain, strong and unbearable pain; The scale of faces will be presented to the volunteer who will demarcate the one closest to the current state; The pressure test will be offered by the numerical scale offered by the device itse

Secondary

MeasureTime frame
We do not expect secondary outcomes

Countries

Brazil

Contacts

Public ContactThomas Barbin

Faculdade de Odontologia de Piracicaba- Universidade Estadual de Campinas

t177672@dac.unicamp.br+55 19 2106-5310

Outcome results

None listed

Source: REBEC (via WHO ICTRP)