Clinical trial NCT03339739: Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain
Official title: Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Disorders
Keywords: Musculoskeletal Pain
Orofacial Pain
Physical Therapy Modalities
Oral Contraceptives
Mandibular Diseases
Muscular Diseases
Risk factors
Contraceptive Usage
Pain, Chronic
Craniomandibular Disorders
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the weekly mean subjective pain index after 21 days of treatment
timeFrame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
measure: Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
timeFrame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
measure: Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
timeFrame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Secondary outcomes:
measure: Change in pressure pain threshold at temporalis muscle after 1 week of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
measure: Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
measure: Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
measure: Change in pressure pain threshold at masseter muscle after 1 week of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
measure: Change in pressure pain threshold at masseter muscle after 2 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
measure: Change in pressure pain threshold at masseter muscle after 3 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
measure: Change in pressure pain tolerance at temporalis muscle after 1 week of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
measure: Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
measure: Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
measure: Change in pressure pain tolerance at masseter muscle after 1 week of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
measure: Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
measure: Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment
timeFrame: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
measure: Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment
timeFrame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Andres Bello
name: Juan F Oyarzo, Prof
role: PRINCIPAL_INVESTIGATOR
References: