Phase 2
N=51
Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients
Temporomandibular Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03454581 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change From Baseline in Visual Analogic Scale (VAS) for Pain — 4.1; 4.4; 5.2; 3.3 millimeters — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Photobiomodulation (Procedure); Manual Therapy (MT) (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Federal University of Rio Grande do Sul
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Visual Analogic Scale (VAS) for Pain |
4.1; 4.4; 5.2; 3.3; 2.8; 3.4 | <0.001 sig |
| SECONDARY Change at Jaw Movements |
29.64; 27.92; 29.71; 35.27; 34.00; 31.50 | 0.05 |
| SECONDARY Change on Chronic Pain Grades |
10; 12; 7; 4; 1; 7 | 0.05 |
| SECONDARY Changes on Levels of Depression Symptoms |
6; 7; 3; 8; 6; 11 | <0.05 sig |
| SECONDARY Change on Nonspecific Physical Symptoms With Pain |
3; 5; 2; 11; 8; 12 | <0.01 sig |
| SECONDARY Change on Nonspecific Physical Symptoms Without Pain |
5; 6; 2; 9; 7; 12 | 0.05 |
| SECONDARY Changes on Mandibular Function |
0.5; 0.85; 0.93; 0.29; 0.38; 0.57 | 0.05 |
| SECONDARY Changes on Levels of Anxiety |
17.86; 14.92; 31.21; 9.57; 7.92; 13.57 | 0.05 |
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.
Eligibility Criteria
Inclusion Criteria
- TMD myogenic and arthrogenic diagnosis based in RDC/TMD Axis I analysis
- Pain in temporomandibular joint (TMJ)
- Limitation in mouth opening.
Exclusion Criteria
- Current dental or physical treatment
- Polyarthritis and other rheumatic diseases
- Use of anti-inflammatory and muscle relaxant
Data sourced from ClinicalTrials.gov (NCT03454581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.