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

Primary Purpose

Muscle Type Temporomandibular Disorders, Myofascial Pain of the Masticatory Muscles

Status
Unknown status
Phase
Phase 2
Locations
Portugal
Study Type
Interventional
Intervention
Citalopram 10 MG
Amitriptyline
Bite Splint
Sponsored by
University of Coimbra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Type Temporomandibular Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHUC - Centro Hospitalar e Universitário de Coimbra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Citalopram

Amitriptyline

Bite Splint

Arm Description

Citalopram 10mg

Amitritptyline 25 mg

Michigan Splint, nocturnal use

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 10, 2021
Last Updated
March 1, 2021
Sponsor
University of Coimbra
Collaborators
Instituto de Investigación Biomédica de Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT04777838
Brief Title
Myofascial Pain Patients' Response to the Administration of Low Doses of Amitriptyline and Citalopram Compared With the Use of Bite Splint
Official Title
Effectiveness of the Use of Antidepressants in the Treatment of Muscle Type Temporomandibular Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
Collaborators
Instituto de Investigación Biomédica de Salamanca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Type Temporomandibular Disorders, Myofascial Pain of the Masticatory Muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Citalopram
Arm Type
Active Comparator
Arm Description
Citalopram 10mg
Arm Title
Amitriptyline
Arm Type
Active Comparator
Arm Description
Amitritptyline 25 mg
Arm Title
Bite Splint
Arm Type
Active Comparator
Arm Description
Michigan Splint, nocturnal use
Intervention Type
Drug
Intervention Name(s)
Citalopram 10 MG
Intervention Description
10 mg of citalopram every day
Intervention Type
Drug
Intervention Name(s)
Amitriptyline
Intervention Description
25mg of Amitriptyline every
Intervention Type
Device
Intervention Name(s)
Bite Splint
Intervention Description
Night use of occlusal splint
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity according to a visual analogue scale from 0 to 10.
Time Frame
3 weeks
Title
Pain intensity
Description
Pain intensity according to a visual analogue scale from 0 to 10.
Time Frame
6 weeks
Title
Pain intensity
Description
Pain intensity according to a visual analogue scale from 0 to 10.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno M Sousa
Phone
+351962607005
Email
bsousa@fmed.uc.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno M Sousa
Organizational Affiliation
Institute for Occlusion and Orofacial Pain Faculty of Medicine, University of Coimbra
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHUC - Centro Hospitalar e Universitário de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno M Sousa, PhD
Phone
+351962018985
Email
bsousa@fmed.uc.pt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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