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

COVID-19 Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430776
• Other study ID #: PBMPOSTCOVID
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: September 20, 2023

Study information

• Verified date: June 2022
• Source: University of Nove de Julho
• Contact: Lara MOTTA, PhD
• Phone: 11998829511
• Email: larajmotta[@]terra.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 20, 2023
• Est. primary completion date: May 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Facial Pain
• Headache
• Orofacial Pain
• Tension-Type Headache

Intervention

Radiation:
• Photobimodulation
laser therapy application

Locations

Country	Name	City	State
Brazil	Nove de Julho Univ	São Paulo	SP
Brazil	Lara Motta	Sao Roque	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	headache and orofacial pain	headache and orofacial pain by analogic visual escale	four weeks