Self-management and Home Exercises for the Treatment of Masticatory Muscle Pain. A Clinical Trial
Condition: Myalgia of Mastication Muscle
MeSH terms: Myalgia
Study type: Interventional

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. 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.
    

Intervention name(s): Self-management; Home exercises
Intervention type(s): Behavioral; Other
Intervention description(s): 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.; It is based on home self-exercise routine. Basic exercise therapy includes mobilization, stretching, and muscle strengthening exercises
Other intervention name(s): SF; EX
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: temporomandibular joint disorders; myalgia; self-care; self-management