Myalgia of Mastication MuscleNCT06054490
Self-management and Home Exercises for the Treatment of Masticatory Muscle Pain. A Clinical Trial
A study testing Self-management and Home exercises in people with Myalgia of Mastication Muscle, run by Universidad Nacional Andres Bello.
Trial summary
The objective of this study was to compare the clinical effectiveness of self-management (SM) together with mandibular home exercises (EX) in the treatment of myalgia of the masticatory muscles. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Myalgia of Mastication Muscle
- What is being tested?
- Self-management and Home exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- "Age between 18 and 40 years", "Presence of myalgia of the masticatory muscles according to DC / TMD diagnostic criteria."
Who cannot join
- "Painful joint TMD"; "history of treatment for TMD"; "recent history of facial or cervical trauma"; "ongoing orthodontic treatment"; "Tooth mobility secondary to periodontal disease"; "Subjects with loss of more than two teeth other than third molars and / or premolars due to orthodontic indication"; "subjects with systemic musculoskeletal diseases or who are under analgesic treatment"; "Subjects with a diagnosed intellectual disability who cannot express their will to participate in scientific research as established by law 20.584 of Chile."
About this study
The objective of this study was to compare the clinical effectiveness of self-management (SM) together with mandibular home exercises (EX) in the treatment of myalgia of the masticatory muscles. A controlled clinical trial was carried out with a total of 48 subjects diagnosed with myalgia according to the diagnostic criteria for temporomandibular disorders (DC/TMD), who were randomized into two groups: treated with SM (SM group) and treated with SM and mandibular home exercises (SM-EX group). The follow-ups were carried out at 2, 6 and 10 weeks, where the following were evaluated: pain in the masticatory muscles, range of mandibular movement and mandibular functional limitation.
Read the detailed description
Materials and method. This randomized controlled clinical trial was conducted between January 2016 and June 2016 at the Andres Bello University Dental Clinic (Viña del Mar, Chile). Study subjects were recruited from the universe of patients seeking treatment for jaw pain at the School of Dentistry. All subjects were informed about the study by their operator and gave their written consent before beginning the study. The protocol, design, and implementation were approved by the Scientific Ethics Committee of the Faculty of Dentistry of the Andres Bello University, Viña del Mar, Chile (Folio No. 056, year 2016). Which was in accordance with the latest version of the Declaration of Helsinki of the World Medical Association (Declaration of the World Medical Association of Helsinki, 2013).
Sample's size calculation. An error percentage of 7% was calculated according to a confidence level of 91%, considering a prevalence of chewing muscle pain of 9% and an expected loss of 1.08% based on the losses obtained in the study carried out by Kalamir. et al. in 2012 (Kalamir et al., 2012). The minimum number of participants required for each group was 25 patients (50 patients in total).
Randomization and interventions. After meeting the inclusion and exclusion criteria, subjects were randomly assigned to two groups using a computer generated sequence "random list" developed by random.org.
Evaluation methods. The initial evaluation, to determine the degree of involvement of axis I, was carried out following the symptom questionnaire and clinical examination guidelines according to the DC/TMD protocol. Additionally, the questionnaire for the chronic pain grade scale (GCPS v2.0) and the functional limitation scale (JFLS-20) of axis II of the DC/TMD protocol were applied. In turn, an intraoral clinical examination was performed to rule out pain of dental origin.
Statistic analysis. Demographic characteristics of the sample were reported descriptively. Data were analyzed using Wilcoxon signed-rank test for comparisons between periods (initial evaluation, and weeks 2, 6, and 10) and Wilcoxon rank-sum test for comparison between groups of the variables MMP, MRM, JFLS-20. Qualitative evaluation of adherence to self-management was analyzed using Fisher exact test. Qualitative evaluation of adherence to home exercises was descriptively reported. The level of significance was established at p=0.05. All statistical analysis was performed using R-Crain 3.01 software.
- Conditions
- Myalgia of Mastication Muscle
- Being tested
- Self-management, Home exercises
- Keywords
- temporomandibular joint disorders, myalgia, self-care, self-management
- Medical subject headings
- Temporomandibular Joint Disorders, Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-managementBehavioural
Also called SF
It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses self-management techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state. In addition, relaxation techniques, sleep hygiene, diet modification, thermotherapy, encouragement to practice social and aerobic activities, and how to prevent risk factors and bad habits.
Home exercisesOther
Also called EX
It is based on home self-exercise routine. Basic exercise therapy includes mobilization, stretching, and muscle strengthening exercises
| Study group | Role | What they receive |
|---|---|---|
| Self-management group (SM group) | Active comparator | Subjects in this group received a scheme of self-management protocol consisting of verbal and written information on the etiology and prognosis of TMD. Receives: Behavioral: Self-management; Other: Home exercises |
| Self-management plus home exercises group (SM+EX group) | Experimental | Subjects in this group received self-management protocol in combination with a home self-exercise routine. Basic exercise therapy includes mobilization, stretching, and muscle strengthening exercises. Receives: Other: Home exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Masticatory muscle pain (MMP)
Pain intensity was measured using a verbal numeric scale (VNS); subjects were asked to verbally rate the perceived intensity using a numerical rating scale where "0" corresponded to "no pain" and "10" corresponded to "extremely strong pain"
Measured: It was applied in the initial evaluation, week 2, 6 and 10
Secondary outcomes (4)
Mandibular range of motion (MRM)
Maximum mouth opening in an autonomous and comfortable way, that is, without feeling pain and not assisted by the operator, measured in millimeters from incisal edge to incisal edge of anterior teeth, compensating for overbite
Measured: It was applied in the initial evaluation, week 2, 6 and 10
Jaw functional limitation (JFLS-20)
Scale in charge of globally assessing masticatory limitation, vertical mobility limitation, verbal and non-verbal communication limitation, included within a 20-item instrument thanks to the survey of mandibular functional limitation of the DC / TMD. This scale has a score of 0 to 10, with 10 being a severe limitation
Measured: It was applied in the initial evaluation and week 10
Qualitative evaluation of adherence to self-management
Qualitative evaluation of subjects' adherence to a self-care protocol scheme that was categorized as "good" (⅔ of the time), "moderate" (between ⅔ and ⅓ of the time), and "deficient" (less than ⅓ of the time). Recorded in a "behavior and self-care log per session"
Measured: It was applied in the initial evaluation, week 2, 6 and 10
Qualitative evaluation of adherence to home exercises
Qualitative evaluation of subjects' adherence to a routine self-exercise therapy at home, as recorded in a "patient diary" that was categorized as "good" (⅔ of the time), "moderate" (between ⅔ and ⅓ of the time) and "deficient" (less than ⅓ of the time).
Measured: It was applied only to the SM+EX group in weeks 2, 6, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2023
- Study startJan 2016
- Primary completionApr 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myalgia of Mastication MuscleStudies 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
- Model description
- The patients were contacted by telephone the day before each session appointment to avoid dropouts and to remember to keep an exercise record if applicable. The treatment of the subjects consisted of 5 sessions. (S1) evaluation and diagnosis of recruited subjects; (S2) three days after S1, SM instruction and explanations of the follow-up sessions were given to all subjects, in addition home exercises were instructed and explained to the SM+EX group; (S3) first control and reinforcement of SM (or SM and exercises) at 2 weeks; (S4) second control and reinforcement of SM (or SM and exercises) at 6 weeks; (S5) third control and is encouraged to continue with SM. Referral to a specialist is made if initial symptom remission has not been achieved.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Andres Bello
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Javier Salinas Aguilar, Universidad Nacional Andres Bello
- Investigators
- Diego De Nordenfycht, Principal investigator, Universidad Nacional Andres Bello
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06054490
- Sponsor's protocol ID
- 10.17605/OSF.IO/EFBC2
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2023
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the collected IPD, study protocol, statistical analysis plan, informed consent form and a clinical study report will be shared, including results, discussion and bibliography studied.
Publications
Kalamir A, Bonello R, Graham P, Vitiello AL, Pollard H. Intraoral myofascial therapy for chronic myogenous temporomandibular disorder: a randomized controlled trial. J Manipulative Physiol Ther. 2012 Jan;35(1):26-37. doi: 10.1016/j.jmpt.2011.09.004. Epub 2011 Nov 10.
PubMed 22079052
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management and Home Exercises for the Treatment of Masticatory Muscle Pain. A Clinical Trial
- ClinicalTrials.gov ID
- NCT06054490
- Acronym / sponsor ID
- 10.17605/OSF.IO/EFBC2
- Conditions
- Myalgia of Mastication Muscle
- Keywords
- temporomandibular joint disorders, myalgia, self-care, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Nacional Andres BelloUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 26 Sep 2023 (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 objective of this study was to compare the clinical effectiveness of self-management (SM) together with mandibular home exercises (EX) in the treatment of myalgia of the masticatory muscles. A controlled clinical trial was carried out with a total of 48 subjects diagnosed with myalgia according to the diagnostic criteria for temporomandibular disorders (DC/TMD), who were randomized into two groups: treated with SM (SM group) and treated with SM and mandibular home exercises (SM-EX group). The follow-ups were carried out at 2, 6 and 10 weeks, where the following were evaluated: pain in the masticatory muscles, range of mandibular movement and mandibular functional limitation.
Detailed description
Materials and method. This randomized controlled clinical trial was conducted between January 2016 and June 2016 at the Andres Bello University Dental Clinic (Viña del Mar, Chile). Study subjects were recruited from the universe of patients seeking treatment for jaw pain at the School of Dentistry. All subjects were informed about the study by their operator and gave their written consent before beginning the study. The protocol, design, and implementation were approved by the Scientific Ethics Committee of the Faculty of Dentistry of the Andres Bello University, Viña del Mar, Chile (Folio No. 056, year 2016). Which was in accordance with the latest version of the Declaration of Helsinki of the World Medical Association (Declaration of the World Medical Association of Helsinki, 2013).
Sample's size calculation. An error percentage of 7% was calculated according to a confidence level of 91%, considering a prevalence of chewing muscle pain of 9% and an expected loss of 1.08% based on the losses obtained in the study carried out by Kalamir. et al. in 2012 (Kalamir et al., 2012). The minimum number of participants required for each group was 25 patients (50 patients in total).
Randomization and interventions. After meeting the inclusion and exclusion criteria, subjects were randomly assigned to two groups using a computer generated sequence "random list" developed by random.org.
Evaluation methods. The initial evaluation, to determine the degree of involvement of axis I, was carried out following the symptom questionnaire and clinical examination guidelines according to the DC/TMD protocol. Additionally, the questionnaire for the chronic pain grade scale (GCPS v2.0) and the functional limitation scale (JFLS-20) of axis II of the DC/TMD protocol were applied. In turn, an intraoral clinical examination was performed to rule out pain of dental origin.
Statistic analysis. Demographic characteristics of the sample were reported descriptively. Data were analyzed using Wilcoxon signed-rank test for comparisons between periods (initial evaluation, and weeks 2, 6, and 10) and Wilcoxon rank-sum test for comparison between groups of the variables MMP, MRM, JFLS-20. Qualitative evaluation of adherence to self-management was analyzed using Fisher exact test. Qualitative evaluation of adherence to home exercises was descriptively reported. The level of significance was established at p=0.05. All statistical analysis was performed using R-Crain 3.01 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients were contacted by telephone the day before each session appointment to avoid dropouts and to remember to keep an exercise record if applicable. The treatment of the subjects consisted of 5 sessions. (S1) evaluation and diagnosis of recruited subjects; (S2) three days after S1, SM instruction and explanations of the follow-up sessions were given to all subjects, in addition home exercises were instructed and explained to the SM+EX group; (S3) first control and reinforcement of SM (or SM and exercises) at 2 weeks; (S4) second control and reinforcement of SM (or SM and exercises) at 6 weeks; (S5) third control and is encouraged to continue with SM. Referral to a specialist is made if initial symptom remission has not been achieved.
| Arm | Type | Receives |
|---|---|---|
| Self-management group (SM group) | Active comparator | Behavioral: Self-management, Other: Home exercisesSubjects in this group received a scheme of self-management protocol consisting of verbal and written information on the etiology and prognosis of TMD. |
| Self-management plus home exercises group (SM+EX group) | Experimental | Other: Home exercisesSubjects in this group received self-management protocol in combination with a home self-exercise routine. Basic exercise therapy includes mobilization, stretching, and muscle strengthening exercises. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- "Age between 18 and 40 years", "Presence of myalgia of the masticatory muscles according to DC / TMD diagnostic criteria."
Key exclusion criteria (1 listed)
- "Painful joint TMD"; "history of treatment for TMD"; "recent history of facial or cervical trauma"; "ongoing orthodontic treatment"; "Tooth mobility secondary to periodontal disease"; "Subjects with loss of more than two teeth other than third molars and / or premolars due to orthodontic indication"; "subjects with systemic musculoskeletal diseases or who are under analgesic treatment"; "Subjects with a diagnosed intellectual disability who cannot express their will to participate in scientific research as established by law 20.584 of Chile."
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 |
|---|---|---|
| Self-managementAlso: SFIt is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses self-management techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state. In addition, relaxation techniques, sleep hygiene, diet modification, thermotherapy, encouragement to practice social and aerobic activities, and how to prevent risk factors and bad habits. | Behavioural | Self-management group (SM group) |
| Home exercisesAlso: EXIt is based on home self-exercise routine. Basic exercise therapy includes mobilization, stretching, and muscle strengthening exercises | Other | Self-management group (SM group), Self-management plus home exercises group (SM+EX group) |
Primary outcome
Masticatory muscle pain (MMP)
Time frame: It was applied in the initial evaluation, week 2, 6 and 10
Pain intensity was measured using a verbal numeric scale (VNS); subjects were asked to verbally rate the perceived intensity using a numerical rating scale where "0" corresponded to "no pain" and "10" corresponded to "extremely strong pain"
4 secondary outcomes
Mandibular range of motion (MRM)
Time frame: It was applied in the initial evaluation, week 2, 6 and 10
Jaw functional limitation (JFLS-20)
Time frame: It was applied in the initial evaluation and week 10
Qualitative evaluation of adherence to self-management
Time frame: It was applied in the initial evaluation, week 2, 6 and 10
Qualitative evaluation of adherence to home exercises
Time frame: It was applied only to the SM+EX group in weeks 2, 6, and 10
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 26 Sep 2023.
- Background: PubMed 22079052Kalamir A, Bonello R, Graham P, Vitiello AL, Pollard H. Intraoral myofascial therapy for chronic myogenous temporomandibular disorder: a randomized controlled trial. J Manipulative Physiol Ther. 2012 Jan;35(1):26-37. doi: 10.1016/j.jmpt.2011.09.004. Epub 2011 Nov 10.
- Description The DC/TMD is intended for use in both clinical settings and applied research settings.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. All the collected IPD, study protocol, statistical analysis plan, informed consent form and a clinical study report will be shared, including results, discussion and bibliography studied.
Related trials for Myalgia of Mastication Muscle
RecruitingObservational study
Occlusal Equilibration vs. Sham Therapies for TMDs: Post-Trial Follow-up (OEST)
Temporomandibular Disorders (TMD), Myalgia of Mastication Muscle
Enrolling by invitationObservational study
Botulinum Toxin in the Management of Temporo-mandibular Related Myalgia: a Prospective Study
TMD/Orofacial Pain, Myalgia of Mastication Muscle
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.
Diego De Nordenfycht principal investigator
Universidad Nacional Andres Bello
Questions about this trial
What is this clinical trial studying?
A study testing Self-management and Home exercises in people with Myalgia of Mastication Muscle, 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 1 inclusion and 1 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 26 Sep 2023. 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. 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?
Masticatory muscle pain (MMP) (time frame: It was applied in the initial evaluation, week 2, 6 and 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06054490, which also lists 1 linked publication.
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 26 Sep 2023.