Aerobic Physical Activity and Orofacial Myofascial Pain

NCT07526688 | Not Yet Recruiting

• 2 other identifiers: 29BRC25.0313 - AERODOFIDRCB
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Orofacial myofascial pain, most commonly represented by Temporomandibular Disorders (TMD) a significant public health, affecting approximately 12% to 14% of the general population. These disorders are characterized by musculoskeletal pain in the masticatory muscles and joints, leading to reduced productivity and high socio-economic costs. Pathophysiological mechanisms are largely central in origin, similar to other chronic pain syndromes like fibromyalgia. Beyond pain, TMD severely impacts oral health-related quality of life by disrupting vital functions such as mastication and swallowing, and is frequently associated with accelerated dental structure loss due to clenching or grinding. While aerobic exercise is a recommended frontline treatment for many chronic pain conditions due to its ability to induce short-term hypoalgesia and long-term neuroplastic adaptations, it remains critically underutilized in the management of orofacial pain. This controlled clinical study aims to compare a pain neuromodulation mechanism (Temporal Summation of Pain) among patients suffering from chronic orofacial myofascial pain, inactive healthy individuals, and healthy individuals practicing endurance sports. Furthermore, investigating Endogenous Pain Modulation (EPM) in pain-free populations allows for a better understanding of how physical activity modulates pain pathways by eliminating confounding factors associated with pre-existing painful conditions. This knowledge will help clarify how aerobic exercise can be utilized within preventive and therapeutic strategies for the management of orofacial myofascial pain. Moreover, it will facilitate the identification of efficacy markers for therapies such as exercise rehabilitation and physical activity.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Orofacial myofascial pain; TMD; Aerobic Physical Activity

Outcome Measures

Primary Outcomes (1)

• Pain facilitation profile : masseter muscle

  ΔTSP : Comparison of the Temporal Summation of Pain score (10th stimulation score minus 1st stimulation score) at the masseter muscle using calibrated pinprick stimuli (calibrated to induce a baseline pain of 20/100) between the 3 groups (TDM ; control group and sports group).

  Inclusion

Secondary Outcomes (9)

• Temporal summation at the forearm muscle

  Inclusion

• Referred sensations at the Masseter muscle

  Inclusion

• Anxiety assessment

  Inclusion

• Depression assessment

  Inclusion

• Assessment of physical activity and sedentary behavior: IPAQ short form

  Inclusion

Study Arms (1)

Evaluation of the chronic orofacial pain

OTHER

All participants will follow the same procedure, which consists of completing several validated, standardized questionnaires. These questionnaires assess various psychological and emotional aspects, including anxiety (GAD-7) and depressive symptoms (PHQ-4), physical activity (IPAQ) and daytime sleepiness (Epworth Sleepiness Scale). Additionally, cardiovascular parameters will be collected.

Other: Temporal Summation of Pain and Questionnaire

Interventions

Temporal Summation of Pain and Questionnaire OTHER

All participants will follow the same study procedure, which consists of : * completing several validated, standardized questionnaires. These questionnaires assess various psychological and emotional aspects, including anxiety (GAD-7) and depressive symptoms (PHQ-4), physical activity (IPAQ) and daytime sleepiness (Epworth Sleepiness Scale). * Collected of cardiovascular parameters. * Assesed of Temporal Summation of Pain : application of repetitive stimuli with pinprick on the skin above the masseter muscle. * Sensation at the level of masseter muscle

Evaluation of the chronic orofacial pain

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants:
• Must be of legal age (18 years or older).
• Must be fully informed of the study constraints and have provided written informed consent.
• Must be registered with a social security scheme.
• TMD-M Group (Orofacial Myofascial Pain):
• Diagnosis of painful Temporomandibular Disorder (TMD) according to the DC/TMD (Diagnostic Criteria for TMD) clinical standards.
• Athletic Group (Active Healthy Subjects):
• Engagement in a minimum of 3 hours of endurance training per week. This threshold is set in accordance with evidence-based WHO recommendations for adults, stating that at least 30 minutes of regular moderate-intensity physical activity per day reduces the risk of multiple diseases.
• Control Group (Inactive Healthy Subjects) :
• Absence of TMD.
• Absence of regular aerobic physical activity.

You may not qualify if:

• Presence of chronic pain outside of TMD (temporomandibular joint disorder)
• Patient under legal guardianship (guardianship, conservatorship)
• Refusal to participate
• Uncooperative patients, who do not speak or read French fluently, are unable to understand the principle of a pain scale, and are unable to cooperate with the tests.
• Pregnant women

Sponsors & Collaborators

• University Hospital, Brest: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Anais LE FUR-BONNABESSE, MD

CONTACT

0298223330; Anais.lefur-bonnabesse@chu-brest.fr

Marie ORLIAGUET

CONTACT

marie.orliaguet@chu-brest.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04