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

7 listopada 2017 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Rzeczywisty)

45

Faza

  • Nie dotyczy

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 26 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Isometric exercise Group
Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
Inny: 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
Aktywny komparator: Isotonic exercise Group
Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
Inny: 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
Komparator placebo: Counseling Group
Group of participants which receive education brochure and no further interventions.
Behawioralne: Counseling group
subjects included in this group get an education brochure about the disorder and receive no further interventions

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in the weekly mean subjective pain index after 21 days of treatment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Universidad Nacional Andres Bello

Śledczy

  • Główny śledczy: Juan F Oyarzo, Prof, Universidad Andrés Bello

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

18 października 2014

Zakończenie podstawowe (Rzeczywisty)

6 grudnia 2016

Ukończenie studiów (Rzeczywisty)

30 grudnia 2016

Daty rejestracji na studia

Pierwszy przesłany

31 października 2017

Pierwszy przesłany, który spełnia kryteria kontroli jakości

7 listopada 2017

Pierwszy wysłany (Rzeczywisty)

13 listopada 2017

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 listopada 2017

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

7 listopada 2017

Ostatnia weryfikacja

1 listopada 2017

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • PROPRGFO_2013/004

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

Nie

Opis planu IPD

no plan

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Isometric mandibular exercises

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