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

NCT05430776 | Unknown

• 1 other identifier: PBMPOSTCOVID
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Tension-Type Headache; Orofacial Pain; COVID-19

Keywords

tension-type headache; orofacial pain; photobiomodulation; covid-19

Outcome Measures

Primary Outcomes (1)

• headache and orofacial pain

  headache and orofacial pain by analogic visual escale

  four weeks

Study Arms (2)

Local photobiomodulation

ACTIVE COMPARATOR

photobiomodulation with red and infrared laser with local application on pain points and

Radiation: Photobimodulation

Systemic photobiomodulation

EXPERIMENTAL

photobiomodulation with red laser with transcutaneous application in the radial artery.

Radiation: Photobimodulation

Interventions

Photobimodulation RADIATION

laser therapy application

Local photobiomodulation; Systemic photobiomodulation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (2)

Nove de Julho Univ

São Paulo, São Paulo, 18133-399, Brazil

RECRUITING

Lara Motta

São Roque, São Paulo, 18133-399, Brazil

RECRUITING

Related Publications (1)

• Costanti Vilela Campos M, Simoes Velloso Schuler S, de Barros Motta P, Catia Mazzoni A, Cristina da Silva F, Domingues Martins M, Porta Santos Fernandes K, Agnelli Mesquita-Ferrari R, Ratto Tempestini Horliana AC, Kalil Bussadori S, Jansiski Motta L. 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. Medicine (Baltimore). 2022 Nov 18;101(46):e31218. doi: 10.1097/MD.0000000000031218.

  PMID: 36401476 DERIVED

MeSH Terms

Conditions

Tension-Type Headache; Facial Pain; COVID-19

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lara Motta, Phd

  Nove de Julho University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara MOTTA, PhD

CONTACT

11998829511; larajmotta@terra.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 2 groups systemic versus local transcutaneous laser therapy

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: June 24, 2022
• Study Start: May 10, 2022
• Primary Completion: May 10, 2022
• Study Completion: September 20, 2023
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)