Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain
7 november 2017 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
45
Fas
- Inte tillämpbar
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 26 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Aktiv komparator: 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
|
|
Placebo-jämförare: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the weekly mean subjective pain index after 21 days of treatment
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Juan F Oyarzo, Prof, Universidad Andrés Bello
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 oktober 2014
Primärt slutförande (Faktisk)
6 december 2016
Avslutad studie (Faktisk)
30 december 2016
Studieregistreringsdatum
Först inskickad
31 oktober 2017
Först inskickad som uppfyllde QC-kriterierna
7 november 2017
Första postat (Faktisk)
13 november 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 november 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
7 november 2017
Senast verifierad
1 november 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PROPRGFO_2013/004
Plan för individuella deltagardata (IPD)
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Nej
IPD-planbeskrivning
no plan
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