Temporomandibular DisordersNCT03339739
Effects of Mandibular Exercises Effect on Pain Perception and Sensitivity in Mandibular Myofascial Pain
A study testing Isometric mandibular exercises, Isotonic mandibular exercises and Counseling group in people with Temporomandibular Disorders, run by Universidad Nacional Andres Bello.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 26 years, women only
- Conditions the study is for
- Temporomandibular Disorders
- What is being tested?
- Isometric mandibular exercises, Isotonic mandibular exercises and Counseling group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2014to 30 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Temporomandibular Disorders
- Being tested
- Isometric mandibular exercises, Isotonic mandibular exercises, Counseling group
- Keywords
- Musculoskeletal Pain, Orofacial Pain, Physical Therapy Modalities, Oral Contraceptives, Mandibular Diseases, Muscular Diseases, Risk factors, Contraceptive Usage, Pain, Chronic, Craniomandibular Disorders
- Medical subject headings
- Temporomandibular Joint Disorders, Musculoskeletal Pain, Facial Pain, Mandibular Diseases, Muscular Diseases, Contraception Behavior, Chronic Pain, Craniomandibular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isometric mandibular exercisesOther
daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars
Isotonic mandibular exercisesOther
daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors
Counseling groupBehavioural
subjects included in this group get an education brochure about the disorder and receive no further interventions
| Study group | Role | What they receive |
|---|---|---|
| Isometric exercise Group | Experimental | Group of participants which perform Isometric mandibular exercises, once a day, for 21 days Receives: Other: Isometric mandibular exercises |
| Isotonic exercise Group | Active comparator | Group of participants which perform Isotonic mandibular exercises, once a day, for 21 days Receives: Other: Isotonic mandibular exercises |
| Counseling Group | Placebo comparator | Group of participants which receive education brochure and no further interventions. Receives: Behavioral: Counseling group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Secondary outcomes (13)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start18 Oct 2014
- Primary completion6 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Fernando Oyarzo, Universidad Nacional Andres Bello
- Investigators
- Juan F Oyarzo, Prof, Principal investigator, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339739
- Sponsor's protocol ID
- PROPRGFO_2013/004
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mandibular Exercises Effect in Pain Perception and Sensitivity in Women With Myofascial Pain, a Double Blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03339739
- Acronym / sponsor ID
- PROPRGFO_2013/004
- Conditions
- Temporomandibular Disorders
- Keywords
- Musculoskeletal Pain, Orofacial Pain, Physical Therapy Modalities, Oral Contraceptives, Mandibular Diseases, Muscular Diseases, Risk factors, Contraceptive Usage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Study start
- 18 Oct 2014 (actual)
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isometric exercise Group | Experimental | Other: Isometric mandibular exercisesGroup of participants which perform Isometric mandibular exercises, once a day, for 21 days |
| Isotonic exercise Group | Active comparator | Other: Isotonic mandibular exercisesGroup of participants which perform Isotonic mandibular exercises, once a day, for 21 days |
| Counseling Group | Placebo comparator | Behavioral: Counseling groupGroup of participants which receive education brochure and no further interventions. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Other orofacial pain diagnosis
- Oral surgery within 6 months
- Treatment for pain management within past 30 days
- Neurological or psychiatric disorders
- Orthodontic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isometric mandibular exercisesdaily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars | Other | Isometric exercise Group |
| Isotonic mandibular exercisesdaily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors | Other | Isotonic exercise Group |
| Counseling groupsubjects included in this group get an education brochure about the disorder and receive no further interventions | Behavioural | Counseling Group |
Primary outcome
Change in the weekly mean subjective pain index after 21 days of treatment
Time frame: 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.
Change in the weekly mean pressure pain threshold (PPT) after 21 days of treatment
Time frame: 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.
Change in the weekly mean pressure pain tolerance (PPTol) after 21 days of treatment
Time frame: 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.
13 secondary outcomes
Change in pressure pain threshold at temporalis muscle after 1 week of treatment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Individual participant dataSharing planned: No. no plan
Related trials for Temporomandibular Disorders
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan F Oyarzo, Prof principal investigator
Universidad Nacional Andres Bello
Questions about this trial
What is this clinical trial studying?
A study testing Isometric mandibular exercises, Isotonic mandibular exercises and Counseling group in people with Temporomandibular Disorders, run by Universidad Nacional Andres Bello.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the weekly mean subjective pain index after 21 days of treatment (time frame: Visit 1 (study day 0) and Visit 4 (study day 3) ( duration study 21 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017; AzTrials last refreshed its copy on 4 Nov 2026.