Trials / Completed
CompletedNCT03339739
Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain
Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- Universidad Nacional Andres Bello · Academic / Other
- Sex
- Female
- Age
- 18 Years – 26 Years
- Healthy volunteers
- Not accepted
Summary
The effectiveness of mandibular exercises as a treatment of muscular Orofacial Pain is yet unknown. This study hypothesized that training exercises can be an effective therapy improving pain perception.
Detailed description
Temporomandibular disorders (TMDs) represent heterogeneous musculoskeletal disorders, where most common presentation is mandibular muscle pain, which is also more common among female than men. Many interventions have been proposed for this pain control, regarding drugs, oral splints, relaxing exercises and self awareness but little is known about mandibular active contraction exercises. The aim of this study is to evaluate the effects of mandibular exercises in pain perception and sensitivity in women. A double blind randomized clinical trial will be conducted among fertile university student women with Oral Contraceptives (OC) use -to control hormonal influences-, with report of facial pain and myofascial pain diagnosis (RDC/TMD). They will be assessed in Visual analogue scale (VAS), sleep quality, Pressure Pain Threshold (PPT) and pressure pain tolerance (PPTol), and then allocated in one of the three interventions for 21 days: isometric mandibular active exercises over silicone bars; video-guided isotonic mandibular contractions over cloth pegs or counseling about disorders nature as passive comparison. After 21 days, VAS, PPT and PPTol in bilateral temporalis and masseter muscles will be assessed for a second time,) and compared with initial pain status. Data will be entered by single blind operator, and will be open for quality auditing. Site monitoring will be performed by the University clinical entities. Data checks will be also performed as planned. Descriptive and analytical statistics will be performed to address the primary and secondary objectives.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Isometric mandibular exercises | daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars |
| OTHER | Isotonic mandibular exercises | daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors |
| BEHAVIORAL | Counseling group | subjects included in this group get an education brochure about the disorder and receive no further interventions |
Timeline
- Start date
- 2014-10-18
- Primary completion
- 2016-12-06
- Completion
- 2016-12-30
- First posted
- 2017-11-13
- Last updated
- 2017-11-13
Source: ClinicalTrials.gov record NCT03339739. Inclusion in this directory is not an endorsement.