Skip to content

Evaluation of the effects of Laser associated with Transcutaneous Electrical Nerve Stimulation and Hot Water Bags in the control of Temporomandibular Disorder

Evaluation of the effects of Laser Photobiomodulation Therapy associated with Transcutaneous Electrical Nerve Stimulation and Thermotherapy in the control of Temporomandibular Disorder: randomized clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-86my7w2
Enrollment
Unknown
Registered
2024-07-16
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain syndrome

Interventions

This is a double-blind randomized clinical trial with three intervention groups. Patients will be randomized in blocks. There will be 5 blocks of 12 participants (4 for each treatment group) and 1 blo
Group 2 will receive laser photobiomodulation therapy with transcutaneous electrical nerve stimulation and thermotherapy as placebo
Group 3 will receive laser photobiomodulation therapy as a placebo, and transcutaneous electrical nerve stimulation and thermotherapy. All patients will be informed of the existing treatment groups, b
E02.331.800
E02.594.540

Sponsors

Universidade Estadual de Feira de Santana
Lead Sponsor
Universidade Estadual de Feira de Santana
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Have female biological sex; be at least 18 years old; present pain intensity of 3 or higher measured by the visual analogue scale; present pain for a period greater than or equal to 3 months; possibility of attending the orofacial pain clinic at the State University of Feira de Santana 3 times a week during the treatment period (Monday and Wednesday in the afternoon and Friday in the morning); be diagnosed with Muscular Temporomandibular Disorder, using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)

Exclusion criteria

Exclusion criteria: Patients with a history of temporomandibular joint surgery; Orofacial Pain caused by Neoplasms or Odontogenic Problems; patients who have already undergone treatment for Temporomandibular Dysfunction; continuous use of non-steroidal anti-inflammatory drugs, analgesics, antidepressants or muscle relaxants; patients who have Intracranial, Neurological Disorders or other major causes of Headache; have been diagnosed with Arthralgia in the temporomandibular joint and patients who already knew how Transcutaneous Electrical Stimulation works

Design outcomes

Primary

MeasureTime frame
It is expected to find a decrease of at least 25% in pain intensity, determined by the Visual Analogue Pain Scale, which consists of drawing a 10 cm horizontal line without numbers, with the left end marking “absence of pain ” (corresponding to 0 cm) and on the right “worst possible pain” (10 cm). The measurement of the marking will be carried out with a 10 cm ruler to determine the intensity of the pain;An increase of at least 20% in the width of the mouth opening is expected, which will be performed with the help of a millimeter ruler. The volunteer will be instructed to open their mouth as wide as possible. The maximum voluntary mouth opening will be measured between the distance between the upper and lower central incisors;An increase of at least 25% in the pressure pain threshold is expected, which will be performed using a digital algometer (Kratos digital model DDK), whose flat circular tip of 1 cm2 is applied with a constant force of 0 .5 kgf/cm2/s in the body of the muscle to be tested; When this pressure begins to cause pain, the patient presses a button that stops the pressure exerted by the examiner, marking the pressure pain threshold. This test will be performed bilaterally on the masticatory muscles (masseter, temporalis) and the temporomandibular joint. The joint and each muscle will be tested twice, with a time interval of 5 minutes between tests. The average value between the two measurements will be used as the pressure pain threshold

Secondary

MeasureTime frame
A reduction of at least 1 grade is expected in the Central Awareness Questionnaire, which is composed of two parts, where part A contains 25 statements that can be scored on a 5-point temporal Likert scale (zero to four). The higher the value, the higher the SC degree, which can vary from zero to 100 points in total. Part B assesses whether the patient has previously been diagnosed with any of the diseases included in Central Sensitization syndrome and the year of diagnosis. According to the inventory score, five levels of symptom severity were established: subclinical (0-29 points); light (30-39 points); moderate (40-49 points); severe (50-59 points); extreme (60-100 points)

Countries

Brazil

Contacts

Public ContactCintia Sousa

Universidade Estadual de Feira de Santana

crasousa@uefs.br+55(75)3161-8019

Outcome results

None listed

Source: REBEC (via WHO ICTRP)