Comparative Effectiveness of Photobiomodulation and Manual Therapy Alone or Combined in TMD Patients: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Primary Endpoint
- Change From Baseline in Visual Analogic Scale (VAS) for Pain
Study Overview
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.
Detailed Description
Temporomandibular disorders (TMD) is a complex and multifactorial disease. Therapeutic modalities, as PBM and MT, expected to relief of symptoms, improve of function and reduce the impact of the disease in patient's life. Fifty-one TMD patients were randomly allocated to three groups: PBM group (n=18) using 808 nm, 100 milliwatt (mW), 13.3 J ∕cm2, 4 J per point), MT group (n=16) with 21 minutes sessions of MT of the masticatory muscles and TMJ and Combined Therapy group (CT) (n=17) applying the 2 protocol described above. All treatments were done three times a week for four consecutive weeks. Evaluations were performed at baseline, during the treatment (days 7, 14, 21, and 28) and follow up (day 60 and day 90). Visual analogue scale (VAS), Research Diagnostic Criteria (RDC/TMD) Axis I and II, Beck anxiety inventory (BAI) were used in different moments of evaluation time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Change From Baseline in Visual Analogic Scale (VAS) for Pain
Time Frame: 0,7,14,21,28,60,90 days
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.
Secondary Outcomes
- Change at Jaw Movements(0,28,90 days)
- Changes on Mandibular Function(0, 90 days)
- Changes on Levels of Depression Symptoms(0,90 days)
- Change on Chronic Pain Grades(0,90 days)
- Change on Nonspecific Physical Symptoms With Pain(0, 90 days)
- Change on Nonspecific Physical Symptoms Without Pain(0, 90 days)
- Changes on Levels of Anxiety(0,90 days)
Investigators
Manoela Domingues Martins
Associate Professor
Federal University of Rio Grande do Sul