Self-management and Home Exercises for the Treatment of Masticatory Muscle Pain. A Clinical Trial

NCT06054490 | Completed

• 1 other identifier: 10.17605/OSF.IO/EFBC2
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Myalgia of Mastication Muscle

Keywords

temporomandibular joint disorders; myalgia; self-care; self-management

Outcome Measures

Primary Outcomes (1)

• 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"

  It was applied in the initial evaluation, week 2, 6 and 10

Secondary Outcomes (4)

• Mandibular range of motion (MRM)

  It was applied in the initial evaluation, week 2, 6 and 10

• Jaw functional limitation (JFLS-20)

  It was applied in the initial evaluation and week 10

• Qualitative evaluation of adherence to self-management

  It was applied in the initial evaluation, week 2, 6 and 10

• Qualitative evaluation of adherence to home exercises

  It was applied only to the SM+EX group in weeks 2, 6, and 10

Study Arms (2)

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.

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.

Other: Home exercises

Interventions

Self-management BEHAVIORAL

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.

Also known as: SF

Self-management group (SM group)

Home exercises OTHER

It is based on home self-exercise routine. Basic exercise therapy includes mobilization, stretching, and muscle strengthening exercises

Also known as: EX

Self-management group (SM group); Self-management plus home exercises group (SM+EX group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• "Age between 18 and 40 years", "Presence of myalgia of the masticatory muscles according to DC / TMD diagnostic criteria."

You may not qualify if:

• "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."

Sponsors & Collaborators

• Universidad Nacional Andres Bello: lead

Related Publications (1)

• 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.

  PMID: 22079052 BACKGROUND

Related Links

• Description The DC/TMD is intended for use in both clinical settings and applied research settings.

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Myalgia

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Diego De Nordenfycht

  Universidad Nacional Andres Bello

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the first session, the operator explained to the study subjects the alternatives, benefits and possible complications of the treatments, it was also indicated that at the time of treatment administration they would not be explained to which group they were assigned to protect the blinding of the treatments. The study of the information was carried out with the necessary precautions to allow masking and blinding of the results obtained, achieving an objective analysis of the results by the outcomes assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 26, 2023
• Study Start: January 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 26, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: One-year database availability period, starting August 28, 2023
• Access Criteria: Database will be shared in Open Security Foundation (OSF), a non-profit public organization founded as a support organization for open source security projects.