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Clinical Trials/NCT07526688
NCT07526688Not yet recruitingNot Applicable

Aerobic Physical Activity and Orofacial Myofascial Pain

University Hospital, Brest1 site in 1 country90 target enrollmentStarted: September 1, 2026Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
90
Locations
1
Primary Endpoint
Pain facilitation profile : masseter muscle

Study Overview

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.

Detailed Description

Participants will attend a single assessment session. During this session, temporal summation will be assessed, and participants will complete a set of standardized psychosocial and clinical questionnaires evaluating anxiety, depressive symptoms, sleep, daily physical activity, and sedentary behavior. Cardiovascular parameters will also be recorded.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Arms & Interventions

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.

Intervention: Temporal Summation of Pain and Questionnaire (Other)

Outcomes

Primary Outcomes

Pain facilitation profile : masseter muscle

Time Frame: Inclusion

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).

Secondary Outcomes

  • 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)
  • Daytime Sleepiness Assessment(Inclusion)
  • Evaluation of Cardiovascular parameters(Inclusion)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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