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

NCT ID: NCT04777838

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-31
• Study Completion Date: 2021-05-31

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.

Detailed Description

Temporomandibular Disorders (TMDs) involve alterations of the temporomandibular joint (TMJ), masticatory muscles, and related structures.

Epidemiologic data indicates that 33% of the general population has at least one symptom of a temporomandibular disorder (TMD) and 6% to 7% have TMDs severe enough to seek specific treatment.

The etiology of pain and disability in myofascial pain is understood via a bio- psychosocial model reflecting a complex interaction between physical, behavioral, social, and psychological factors. In turn, the treatment of myofascial pain is often multimodal.

Ongoing pain may be associated with co-morbid conditions such as anxiety, depression and sleeplessness. It is important to recognize and treat emotional distress as well as physical symptoms. Chronic pain and depression seem to share common neurochemical substrata and perhaps even similar dysfunctional alterations.

Chronic syndromes such as bruxism and TMD are commonly associated with depression. Research Investigator reported that 39% of patients with TMD are moderately to severely depressed and 55% have moderate to severe somatization symptoms. A cross-cultural study by List and Dworkin supported these findings, showing that 45% of Swedish patients and 51% of American patients who met the diagnostic criteria for TMD also suffered from moderate to severe depression.

If pain assumes a chronic nature, more centrally mediated mechanisms take effect, for which peripherally acting analgesics have less efficacy. The clinician must recognize the involved alterations in pain characteristics, such as quality, duration, and intensity, as peripheral pain becomes more continuous, diffuse, and difficult to localize. In such instances, the possibility of new targets for treatment emerges.

The prominence of tryciclic antidepressants (TCAs) as a first-line treatment has declined over time and the introduction of more tolerable medications such as the selective serotonin reuptake inhibitors (SSRIs) has been done. TCAs are still used today, but they are most commonly prescribed for patients whose depression does not respond to SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs). TCAs are also used to treat depressed patients with somatization pain or insomnia, due to their low addictive risk and sedative and analgesic qualities; however, TCAs are associated with a high suicide risk when taken in overdose.

For the past several years, tricyclic antidepressants have been used successfully to manage and control a variety of chronic pain conditions. Research Investigators reported that a pharmacological protocol for the control of pain associated with chronic temporomandibular disorders (TMD) based on the use of amitriptyline and found that 25 mg/day of amitriptyline was sufficient to significantly reduce the pain of chronic TMD without producing side effects.

Research Investigator showed that 75 mg of amitriptyline provided significantly more pain relief than 25 or 50mg in patients with chronic pain. However, the patients on higher doses also had more adverse events such as dry mouth and drowsiness. It should also be kept in mind that no dose-response relation- ship has been demonstrated for the antidepressant or mood effects of amitriptyline.

Research Investigator compared the effectiveness of cognitive behavioral therapy (CBT) and amitriptyline in combination and separately in patients with chronic TMD. They discovered improvements in all subgroups (CBT alone, amitriptyline alone, CBT plus amitriptyline, and the placebo group) with an average decrease in pain intensity of 55%. The combination group of CBT plus amitriptyline, however, was the only group that continued to show improved scores on the visual analog pain scale at the follow-up 4 weeks after treatment was completed.

The neurotransmitter serotonin regulates a wide range of functions including sleep, temperature, and mood. Based on that we could suggest that it has a positive impact on Chronic Pain patients. However, Serotonin also suppresses dopamine release from the mesocortical tract, which can result in serotonin-induced disinhibition of movement. In other words, dopamine functions to prevent spontaneous movements, but if serotonin inhibits the action of dopamine, then spontaneous movements can occur. This is thought to be one of the most plausible mechanisms involved in the repetitive muscle contractions seen in bruxism. This mechanism also explains how the SSRIs, which increase concentrations of serotonin, have the ability to deregulate movement and induce bruxism.

Conditions

Muscle Type Temporomandibular Disorders; Myofascial Pain of the Masticatory Muscles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Citalopram

Citalopram 10mg

Group Type: ACTIVE_COMPARATOR

Citalopram 10 MG

Intervention Type: DRUG

10 mg of citalopram every day

Amitriptyline

Amitritptyline 25 mg

Group Type: ACTIVE_COMPARATOR

Amitriptyline

Intervention Type: DRUG

25mg of Amitriptyline every

Bite Splint

Michigan Splint, nocturnal use

Group Type: ACTIVE_COMPARATOR

Bite Splint

Intervention Type: DEVICE

Night use of occlusal splint

Interventions

Citalopram 10 MG

10 mg of citalopram every day

Intervention Type: DRUG

Amitriptyline

25mg of Amitriptyline every

Intervention Type: DRUG

Bite Splint

Night use of occlusal splint

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Investigación Biomédica de Salamanca

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Bruno Macedo de Sousa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruno M Sousa

Role: PRINCIPAL_INVESTIGATOR

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

Locations

CHUC - Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Countries

Portugal

Central Contacts

Bruno M Sousa

Role: CONTACT

bsousa@fmed.uc.pt

+351962607005

Facility Contacts

Bruno M Sousa, PhD

Role: primary

bsousa@fmed.uc.pt

+351962018985

Other Identifiers

ADP2021

Identifier Type: -

Identifier Source: org_study_id