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
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
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
NCT ID
NCT03339739
First Posted
October 31, 2017
Last Updated
November 7, 2017
Sponsor
Universidad Nacional Andres Bello
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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