Myofascial Pain Patients' Response to the Administration of Low Doses of Amitriptyline and Citalopram Compared With the Use of Bite Splint

NCT04777838 | Unknown Phase 2 DMC

• 1 other identifier: ADP2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is evaluate the effectiveness of the use of antidepressants in the treatment of muscle type temporomandibular disorders, with a sample of 60 to 80 participants.

Conditions

Muscle Type Temporomandibular Disorders; Myofascial Pain of the Masticatory Muscles

Outcome Measures

Primary Outcomes (3)

• Pain intensity

  Pain intensity according to a visual analogue scale from 0 to 10.

  3 weeks

• Pain intensity

  Pain intensity according to a visual analogue scale from 0 to 10.

  6 weeks

• Pain intensity

  Pain intensity according to a visual analogue scale from 0 to 10.

  9 weeks

Study Arms (3)

Citalopram

ACTIVE COMPARATOR

Citalopram 10mg

Drug: Citalopram 10 MG

Amitriptyline

ACTIVE COMPARATOR

Amitritptyline 25 mg

Drug: Amitriptyline

Bite Splint

ACTIVE COMPARATOR

Michigan Splint, nocturnal use

Device: Bite Splint

Interventions

Citalopram 10 MG DRUG

10 mg of citalopram every day

Citalopram

Amitriptyline DRUG

25mg of Amitriptyline every

Amitriptyline

Bite Splint DEVICE

Night use of occlusal splint

Bite Splint

Eligibility Criteria

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

You may qualify if:

• Patients treated at the Centro Hospitalar e Universitário de Coimbra (CHUC);
• Patients who, according to the diagnostic Criteria for Temporomandibular disorder (DC/TMD) , present Myofascial pain in the masticatory muscles for more than 6 months;
• Adult patients

You may not qualify if:

• Under 18 years old;
• Pregnants,
• Patients who have related adverse effects to the citalopram and/or amitriptyline;
• Patients presenting severe diseases like coronary pathology, renal insufficiency, active cancer, respiratory insufficiency;
• Patients who have been treated to myofascial pain before

Sponsors & Collaborators

• University of Coimbra: lead
• Instituto de Investigación Biomédica de Salamanca: collaborator

Study Sites (1)

CHUC - Centro Hospitalar e Universitário de Coimbra

Coimbra, 3000-075, Portugal

Location

MeSH Terms

Interventions

Citalopram; Amitriptyline; Occlusal Splints

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Bruno M Sousa

  Institute for Occlusion and Orofacial Pain Faculty of Medicine, University of Coimbra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno M Sousa

CONTACT

+351962607005; bsousa@fmed.uc.pt

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 2, 2021
• Study Start: March 1, 2021
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: March 2, 2021

Record last verified: 2021-03

Locations

PT (1)