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

7. listopadu 2017 aktualizováno: Juan Fernando Oyarzo, Universidad Nacional Andres Bello

Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

45

Fáze

  • Nelze použít

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 26 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Ženský

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Isometric exercise Group
Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
Jiný: 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
Aktivní komparátor: Isotonic exercise Group
Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
Jiný: 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
Komparátor placeba: Counseling Group
Group of participants which receive education brochure and no further interventions.
Behaviorální: Counseling group
subjects included in this group get an education brochure about the disorder and receive no further interventions

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in the weekly mean subjective pain index after 21 days of treatment
Časové okno: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Weekly mean subjective pain computed as the arithmetic mean of daily pain subjective values (visual analog scale - VAS) in Visit 1and prior to each study visit. Daily pain index is computed as pain intensity (0-100 numeric rating scale where 0 = "no pain" and 100 = "the most intense pain imaginable") for the different muscular sites tested.
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
Časové okno: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Weekly mean pressure pain threshold is computed as the arithmetic mean of daily pressure pain threshold values for muscular sites in Visit 1and prior to each study visit. Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
Časové okno: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Weekly mean pressure pain tolerance is computed as the arithmetic mean of daily pressure pain tolerance values for muscular sites in Visit 1and prior to each study visit. Plot is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied per anatomical muscle site.
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
Change in pressure pain threshold at masseter muscle after 1 week of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain threshold at masseter muscle after 2 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Change in pressure pain threshold at masseter muscle after 3 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Pressure values, measured in kilogram-force (kgf), from up to 3 experimental pressure stimuli, bilaterally applied to the area of t masseter muscle, will be averaged to obtain a single pressure pain threshold value per anatomical site.
Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Change in pressure pain tolerance at temporalis muscle after 1 week of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of temporalis muscle.
Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Change in pressure pain tolerance at masseter muscle after 1 week of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment
Časové okno: Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Pressure pain tolerance is captured as a pressure value, measured in kilogram-force (kgf) in 1 experimental pressure stimuli, bilaterally applied to the area of masseter muscle.
Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment
Časové okno: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
The PSQI has 19 items grouped into 7 component scores, each weighted equally on a 0-3 scale. The 7 component scores are summed to obtain a global score, which has a range of 0-21.
Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Universidad Nacional Andres Bello

Vyšetřovatelé

  • Vrchní vyšetřovatel: Juan F Oyarzo, Prof, Universidad Andrés Bello

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. října 2014

Primární dokončení (Aktuální)

6. prosince 2016

Dokončení studie (Aktuální)

30. prosince 2016

Termíny zápisu do studia

První předloženo

31. října 2017

První předloženo, které splnilo kritéria kontroly kvality

7. listopadu 2017

První zveřejněno (Aktuální)

13. listopadu 2017

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2017

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. listopadu 2017

Naposledy ověřeno

1. listopadu 2017

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PROPRGFO_2013/004

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

Popis plánu IPD

no plan

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Studuje lékový produkt regulovaný americkým FDA

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Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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