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Laser Therapy on Tension-type Cephalea and Orofacial Pain in Post-covid-19 Patients

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ClinicalTrials.gov Identifier: NCT05430776
Recruitment Status : Recruiting
First Posted : June 24, 2022
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Lara Jansiski Motta, University of Nove de Julho

Brief Summary:

Considering the auxiliary potential effect of photobiomodulation in controlling persistent CTT and TMD-related pain in patients who have been diagnosed with COVID-19, and are recovered from the viral infection, we intend to conduct a clinical trial comparing two modalities of therapeutic laser application: local application and transcutaneous application in the radial artery.

One of the main advantages of auxiliary techniques in pain control is the decrease of the use of drugs for analgesia, avoiding side effects and tolerance caused by them, and promoting an improvement in the individual's quality of life.


Condition or disease Intervention/treatment Phase
Tension-Type Headache Orofacial Pain COVID-19 Radiation: Photobimodulation Not Applicable

Detailed Description:
Orofacial pain and tensional cephalea were symptoms commonly reported in COVID-19 patients, even after recovery, and were considered chronic pain in these cases. The pain control, in these cases, is mostly accomplished with the use of analgesic and anti-inflammatory drugs. However, there are auxiliary treatments that can reduce the amount of pharmacological intake and improve the quality of life of compromised individuals, one of them is photobiomodulation. Using lasers for treatments to control inflammation and pain is successfully performed, but the parameters and the ways of application are not yet strongly established. The aim of this research is to evaluate the effect of the application of photobiomodulation with red and infrared lasers applied locally and systemically. For this purpose, individuals who have been diagnosed with COVID-19 and have had a tension headache and/or orofacial pain for more than 3 months will be selected by convenience. The participants will be divided into two different groups: G1- photobiomodulation with red and infrared laser with local application on the pain points (808 nm and 660 nm,100 mW, 6J per point) and G2 -photobiomodulation with red laser with transcutaneous application on the radial artery (660 nm, 100mW, 30 minutes). All participants will be treated for a period of 4 weeks, with 8 application sessions. The effects will be measured by means of blood lactate level, Brief Pain Inventory, Visual Analog Scale (VAS), and Cephalea Impact Test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 groups systemic versus local transcutaneous laser therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Systemic Versus Local Transcutaneous Laser Therapy on Tension-type Cephalea and Orofacial Pain in Post-covid-19 Patients: a Pragmatic Randomized Clinical Trial.
Actual Study Start Date : May 10, 2022
Actual Primary Completion Date : May 10, 2022
Estimated Study Completion Date : September 20, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Local photobiomodulation
photobiomodulation with red and infrared laser with local application on pain points and
Radiation: Photobimodulation
laser therapy application

Experimental: Systemic photobiomodulation
photobiomodulation with red laser with transcutaneous application in the radial artery.
Radiation: Photobimodulation
laser therapy application




Primary Outcome Measures :
  1. headache and orofacial pain [ Time Frame: four weeks ]
    headache and orofacial pain by analogic visual escale



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals of both sexes, between the ages of 19 and 65, complaining of persistent orofacial pain or functional-type cephalea, for more than 3 months.
  • Individuals diagnosed with COVID-19, confirmed by RT-PCR for SARS-CoV-2 already recovered, at least 30 days after infection.

Exclusion Criteria:

  • Individuals with diagnoses of neuropathies and headaches other than tension-type headache
  • Physical or intellectual incapacity to answer the survey questionnaires; illiterate; diabetics, pacemakers, and pregnant women.
  • Individuals who report photosensitivity to laser.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05430776


Contacts
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Contact: Lara MOTTA, PhD 11998829511 larajmotta@terra.com.br

Locations
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Brazil
Lara Motta Recruiting
Sao Roque, SP, Brazil, 18133-399
Contact: Lara MOTTA    11998829511    larajmotta@terra.com.br   
Nove de Julho Univ Recruiting
São Paulo, SP, Brazil, 18133-399
Contact: Lara MOTTA, PhD    11998829511    larajmotta@terra.com.br   
Contact: Lara RENE Motta    11998829511    larajmotta@terra.com.br   
Sponsors and Collaborators
University of Nove de Julho
Investigators
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Principal Investigator: Lara Motta, Phd Nove de Julho University
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Responsible Party: Lara Jansiski Motta, PhD, University of Nove de Julho
ClinicalTrials.gov Identifier: NCT05430776    
Other Study ID Numbers: PBMPOSTCOVID
First Posted: June 24, 2022    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lara Jansiski Motta, University of Nove de Julho:
tension-type headache
orofacial pain
photobiomodulation
covid-19
Additional relevant MeSH terms:
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COVID-19
Tension-Type Headache
Headache
Facial Pain
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pain
Neurologic Manifestations
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases