Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain
7 novembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
45
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 26 ans (Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Femelle
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Isometric exercise Group
Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
|
daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars
|
|
Comparateur actif: Isotonic exercise Group
Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
|
daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors
|
|
Comparateur placebo: Counseling Group
Group of participants which receive education brochure and no further interventions.
|
subjects included in this group get an education brochure about the disorder and receive no further interventions
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in the weekly mean subjective pain index after 21 days of treatment
Délai: 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
Délai: 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
Délai: 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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Juan F Oyarzo, Prof, Universidad Andrés Bello
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
18 octobre 2014
Achèvement primaire (Réel)
6 décembre 2016
Achèvement de l'étude (Réel)
30 décembre 2016
Dates d'inscription aux études
Première soumission
31 octobre 2017
Première soumission répondant aux critères de contrôle qualité
7 novembre 2017
Première publication (Réel)
13 novembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
13 novembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 novembre 2017
Dernière vérification
1 novembre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies articulaires
- Maladies musculo-squelettiques
- Maladies musculaires
- Maladies stomatognathiques
- Maladies de la mâchoire
- Troubles craniomandibulaires
- Maladies mandibulaires
- Syndromes de douleur myofasciale
- Troubles de l'articulation temporo-mandibulaire
- Syndrome de dysfonctionnement de l'articulation temporo-mandibulaire
Autres numéros d'identification d'étude
- PROPRGFO_2013/004
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Non
Description du régime IPD
no plan
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Isometric mandibular exercises
-
Centre Hospitalier Universitaire Dinant Godinne...Complété
-
Foundation University IslamabadComplété