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

Primary Purpose

Tension-Type Headache, Orofacial Pain, COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Photobimodulation
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tension-Type Headache focused on measuring tension-type headache, orofacial pain, photobiomodulation, covid-19

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lara MottaRecruiting
  • Nove de Julho UnivRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Local photobiomodulation

Systemic photobiomodulation

Arm Description

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

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

Outcomes

Primary Outcome Measures

headache and orofacial pain
headache and orofacial pain by analogic visual escale

Secondary Outcome Measures

Full Information

First Posted
June 22, 2022
Last Updated
June 22, 2022
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT05430776
Brief Title
Laser Therapy on Tension-type Cephalea and Orofacial Pain in Post-covid-19 Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tension-Type Headache, Orofacial Pain, COVID-19
Keywords
tension-type headache, orofacial pain, photobiomodulation, covid-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups systemic versus local transcutaneous laser therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Local photobiomodulation
Arm Type
Active Comparator
Arm Description
photobiomodulation with red and infrared laser with local application on pain points and
Arm Title
Systemic photobiomodulation
Arm Type
Experimental
Arm Description
photobiomodulation with red laser with transcutaneous application in the radial artery.
Intervention Type
Radiation
Intervention Name(s)
Photobimodulation
Intervention Description
laser therapy application
Primary Outcome Measure Information:
Title
headache and orofacial pain
Description
headache and orofacial pain by analogic visual escale
Time Frame
four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lara MOTTA, PhD
Phone
11998829511
Email
larajmotta@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lara Motta, Phd
Organizational Affiliation
Nove de Julho University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lara Motta
City
Sao Roque
State/Province
SP
ZIP/Postal Code
18133-399
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara MOTTA
Phone
11998829511
Email
larajmotta@terra.com.br
Facility Name
Nove de Julho Univ
City
São Paulo
State/Province
SP
ZIP/Postal Code
18133-399
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lara MOTTA, PhD
Phone
11998829511
Email
larajmotta@terra.com.br
First Name & Middle Initial & Last Name & Degree
Lara RENE Motta
Phone
11998829511
Email
larajmotta@terra.com.br

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36401476
Citation
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.
Results Reference
derived

Learn more about this trial

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

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