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

NCT ID: NCT03339739

Last Updated: 2017-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-18

Study Completion Date

2016-12-30

Brief Summary

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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

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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

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Temporomandibular Disorders

Keywords

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Musculoskeletal Pain Orofacial Pain Physical Therapy Modalities Oral Contraceptives Mandibular Diseases Muscular Diseases Risk factors Contraceptive Usage Pain, Chronic Craniomandibular Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Isometric exercise Group

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

Group Type EXPERIMENTAL

Isometric mandibular exercises

Intervention Type OTHER

daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars

Isotonic exercise Group

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

Group Type ACTIVE_COMPARATOR

Isotonic mandibular exercises

Intervention Type OTHER

daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors

Counseling Group

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

Group Type PLACEBO_COMPARATOR

Counseling group

Intervention Type BEHAVIORAL

subjects included in this group get an education brochure about the disorder and receive no further interventions

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Counseling group

subjects included in this group get an education brochure about the disorder and receive no further interventions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

26 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Universidad Nacional Andres Bello

OTHER

Sponsor Role lead

Responsible Party

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Juan Fernando Oyarzo

Orofacial Pain & TMD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Juan F Oyarzo, Prof

Role: PRINCIPAL_INVESTIGATOR

Universidad Andres Bello

Other Identifiers

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PROPRGFO_2013/004

Identifier Type: -

Identifier Source: org_study_id