Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain

Universidad Nacional Andres Bello

Status: Completed

Conditions: Temporomandibular Disorders

Treatments: Other: Isometric mandibular exercises; Other: Isotonic mandibular exercises; Behavioral: Counseling group

Study type: Interventional

Funder types: Other

Identifiers

NCT03339739

PROPRGFO_2013/004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 26 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Temporomandibular Myofascial pain diagnosis
• Oral contraceptives consumption
• Facial pain for at least 3 months (and at least 10 of the last 30 days at Visit 0)
• Agrees to terms for continuing/discontinuing certain prescription/over-the-counter pain medications.

Exclusion criteria

• Other orofacial pain diagnosis
• Oral surgery within 6 months
• Treatment for pain management within past 30 days
• Neurological or psychiatric disorders
• Orthodontic treatment
• History of pregnancy, pregnancy or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups, including a placebo group

Isometric exercise Group

Experimental group

Description:

Group of participants which perform Isometric mandibular exercises, once a day, for 21 days

Treatment:

Other: Isometric mandibular exercises

Isotonic exercise Group

Active Comparator group

Description:

Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days

Treatment:

Other: Isotonic mandibular exercises

Counseling Group

Placebo Comparator group

Description:

Group of participants which receive education brochure and no further interventions.

Treatment:

Behavioral: Counseling group