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

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Isometric mandibular exercises
Isotonic mandibular exercises
Counseling group
Sponsored by
Universidad Nacional Andres Bello
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Musculoskeletal Pain, Orofacial Pain, Physical Therapy Modalities, Oral Contraceptives, Mandibular Diseases, Muscular Diseases, Risk factors, Contraceptive Usage, Pain, Chronic, Craniomandibular Disorders

Eligibility Criteria

18 Years - 26 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Isometric exercise Group

    Isotonic exercise Group

    Counseling Group

    Arm Description

    Group of participants which perform Isometric mandibular exercises, once a day, for 21 days

    Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days

    Group of participants which receive education brochure and no further interventions.

    Outcomes

    Primary Outcome Measures

    Change in the weekly mean subjective pain index after 21 days of treatment
    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.
    Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
    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.
    Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
    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.

    Secondary Outcome Measures

    Change in pressure pain threshold at temporalis muscle after 1 week of treatment
    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.
    Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment
    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.
    Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment
    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.
    Change in pressure pain threshold at masseter muscle after 1 week of treatment
    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.
    Change in pressure pain threshold at masseter muscle after 2 weeks of treatment
    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.
    Change in pressure pain threshold at masseter muscle after 3 weeks of treatment
    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.
    Change in pressure pain tolerance at temporalis muscle after 1 week of treatment
    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.
    Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment
    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.
    Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment
    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.
    Change in pressure pain tolerance at masseter muscle after 1 week of treatment
    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.
    Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment
    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.
    Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment
    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.
    Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment
    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.

    Full Information

    First Posted
    October 31, 2017
    Last Updated
    November 7, 2017
    Sponsor
    Universidad Nacional Andres Bello
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03339739
    Brief Title
    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

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 18, 2014 (Actual)
    Primary Completion Date
    December 6, 2016 (Actual)
    Study Completion Date
    December 30, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Nacional Andres Bello

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Temporomandibular Disorders
    Keywords
    Musculoskeletal Pain, Orofacial Pain, Physical Therapy Modalities, Oral Contraceptives, Mandibular Diseases, Muscular Diseases, Risk factors, Contraceptive Usage, Pain, Chronic, Craniomandibular Disorders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Isometric exercise Group
    Arm Type
    Experimental
    Arm Description
    Group of participants which perform Isometric mandibular exercises, once a day, for 21 days
    Arm Title
    Isotonic exercise Group
    Arm Type
    Active Comparator
    Arm Description
    Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days
    Arm Title
    Counseling Group
    Arm Type
    Placebo Comparator
    Arm Description
    Group of participants which receive education brochure and no further interventions.
    Intervention Type
    Other
    Intervention Name(s)
    Isometric mandibular exercises
    Intervention Description
    daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars
    Intervention Type
    Other
    Intervention Name(s)
    Isotonic mandibular exercises
    Intervention Description
    daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors
    Intervention Type
    Behavioral
    Intervention Name(s)
    Counseling group
    Intervention Description
    subjects included in this group get an education brochure about the disorder and receive no further interventions
    Primary Outcome Measure Information:
    Title
    Change in the weekly mean subjective pain index after 21 days of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
    Title
    Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
    Title
    Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
    Secondary Outcome Measure Information:
    Title
    Change in pressure pain threshold at temporalis muscle after 1 week of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
    Title
    Change in pressure pain threshold at temporalis muscle after 2 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 14) ( 7 days in between)
    Title
    Change in pressure pain threshold at temporalis muscle after 3 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 21) ( 7 days in between)
    Title
    Change in pressure pain threshold at masseter muscle after 1 week of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
    Title
    Change in pressure pain threshold at masseter muscle after 2 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
    Title
    Change in pressure pain threshold at masseter muscle after 3 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
    Title
    Change in pressure pain tolerance at temporalis muscle after 1 week of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
    Title
    Change in pressure pain tolerance at temporalis muscle after 2 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
    Title
    Change in pressure pain tolerance at temporalis muscle after 3 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
    Title
    Change in pressure pain tolerance at masseter muscle after 1 week of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 7) ( 7 days in between)
    Title
    Change in pressure pain tolerance at masseter muscle after 2 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 14) ( 14 days in between)
    Title
    Change in pressure pain tolerance at masseter muscle after 3 weeks of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 2 (study day 21) ( 21 days in between)
    Title
    Change in the Pittsburgh Sleep Quality Index (PSQI) global score after 21 days of treatment
    Description
    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.
    Time Frame
    Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    26 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juan F Oyarzo, Prof
    Organizational Affiliation
    Universidad Andres Bello
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan

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

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