Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients

NCT03454581 | Completed Phase 2 Results

• 1 other identifier: PBM and MT TMD
• Study Type: interventional
• Target: 51
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present study was to investigate the effect of photobiomodulation (PBM) and manual therapy (MT) isolated or combined in the reduce of pain, the improve of mandibular movements, the psychosocial aspects and the anxiety symptoms of patients with TMD.

Conditions

Temporomandibular Disorder

Keywords

Temporomandibular Diseases; Photobiomodulation; Low level laser; Treatment; Manual Therapy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Visual Analogic Scale (VAS) for Pain

  Visual Analogic Score (VAS) is a psychometric scale used to measure subjective characteristics, as pain. Consists of a 100mm horizontal line with descriptors "no pain" at the initial point (score 0) and "worst pain" at the end point (score 100). To avoid clustering of scores, numbers or verbal descriptors at intermediate points are not recommended. Patients were asked to place a handwritten mark at one point along the 100mm line that best represents their pain intensity. The scores are recorded in millimeters and determined by the measurements from the initial point of the scale to the patients' mark, using a ruler. Higher scores indicate high levels of pain intensity. In this study, the scores (mm) of pain were recorded at days 7, 14, 21, 28, 60 and 90 and compared to the baseline score (day 0) to evaluate the response to each treatment.

  0,7,14,21,28,60,90 days

Secondary Outcomes (7)

• Change at Jaw Movements

  0,28,90 days

• Change on Chronic Pain Grades

  0,90 days

• Changes on Levels of Depression Symptoms

  0,90 days

• Change on Nonspecific Physical Symptoms With Pain

  0, 90 days

• Change on Nonspecific Physical Symptoms Without Pain

  0, 90 days

Study Arms (3)

Photobiomodulation group (PBM)

EXPERIMENTAL

Gallium-aluminium-arsenide (GaAlAs) diode laser (MM Optics Recover, São Carlos, São Paulo, Brazil) with a wavelength of 808 nm, punctual contact mode,spot size of 0.03 cm2, power output of 100 mW, output density of 333 mW∕cm2, energy density of 13.3 J ∕cm2, 40 s exposure time per point, and 4 Joules (J) of total energy per point. 18 individuals

Procedure: Photobiomodulation

Manual Therapy group (MT)

EXPERIMENTAL

At masticatory muscles were performed circular movements, slip and compression with fingers movements. At the temporomandibular joint (TMJ) was performed a caudal distraction with anterior projection, placing the thumb on the second or third molar. 16 individuals.

Procedure: Manual Therapy (MT)

Combined therapy group (CT)

EXPERIMENTAL

Applied the protocols of PBM group and immediately after, to MT group. 17 individuals.

Procedure: Photobiomodulation; Procedure: Manual Therapy (MT)

Interventions

Photobiomodulation PROCEDURE

PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid.

Also known as: Low Level Laser (PBM)

Combined therapy group (CT); Photobiomodulation group (PBM)

Manual Therapy (MT) PROCEDURE

Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week .

Combined therapy group (CT); Manual Therapy group (MT)

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis
• Pain in temporomandibular joint (TMJ)
• Limitation in mouth opening.

You may not qualify if:

• Current dental or physical treatment
• Polyarthritis and other rheumatic diseases
• Use of anti-inflammatory and muscle relaxant

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Low-Level Light Therapy; phytobacteriomycin; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: PhD Manoela Domingues Martins
• Organization: Federal University of Rio Grande do Sul

manomartins@gmail.com

55-51-33085011

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: March 6, 2018
• Study Start: May 17, 2016
• Primary Completion: November 14, 2016
• Study Completion: November 14, 2016
• Last Updated: September 26, 2019
• Results First Posted: September 26, 2019

Record last verified: 2019-08