Aerobic Physical Activity and Orofacial Myofascial Pain (AERODOF)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Temporomandibular Disorders (TMD)
• Intervention / Treatment: Other: Temporal Summation of Pain and Questionnaire

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anais LE FUR-BONNABESSE, MD; Phone Number: 0298223330; Email: Anais.lefur-bonnabesse@chu-brest.fr
• Study Contact Backup: Name: Marie ORLIAGUET; Email: marie.orliaguet@chu-brest.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Evaluation of the chronic orofacial pain; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Temporal summation at the forearm muscle	Temporal summation (TS) will be assessed by applying repetitive stimuli in the form of blunt needle pricks (pinprick) to the skin overlying the forearm muscles. The intensity of the pinprick will be individually calibrated to induce a baseline pain of 20/100 on a Numerical Rating Scale (NRS). Participants will be asked to rate the intensity of the pain provoked by the pinprick. The examiner will first apply a single stimulus, followed by a series of 10 stimuli applied at a frequency of 1 Hz over an area of 1 cm². Pain will be assessed verbally using a numerical rating scale ranging from 0 to 100, with anchors at 0 ('no pain') and 100 ('worst imaginable pain'). The entire procedure will be repeated three times. For the pinprick stimulations, the magnitude of temporal summation (ΔTSP = pain score at the 10th stimulation - pain score at the 1st stimulation) will be calculated.	Inclusion
Referred sensations at the Masseter muscle	The assessment of referred sensation (RS) will be performed using mechanical stimulation. A force of 0.5 and 2.0 kg will be applied to the masseter muscle using a palpometer (Palpeter; Sunstar Suisse SA, Etoy, Switzerland). The stimulation will be repeated 5 times. Each individual mechanical stimulation will last 5 seconds, followed by a 10-second interval allowing the participant to rate the intensity of the sensation and report any RS. Mechanical sensitivity will be evaluated on an NRS scale of 0-50-100 (where 0 corresponds to no sensation, 1-49 to a non-painful sensation, 50 to the pain threshold, and 100 to the most painful sensation). Sensations will be considered referred if the participant reports a sensation extending beyond the boundary of the masseter muscle. If such a sensation occurs, the participant will be asked to point to the location where the sensation was felt, and the examiner will determine if this location lies outside the masseter muscle limits. If participants	Inclusion
Anxiety assessment	Anxiety will be assed by GAD-7 questionnaire ; a 7-item self-administered questionnaire used as a screening tool and a measure of the severity of generalized anxiety disorder. It calculates the score by assigning 0, 1, 2, or 3 points to the response options 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively. The total score for the GAD-7 questionnaire ranges from 0 to 21 points. If GAD-7 score is less than 4 : absence of anxiety, between 5 and 9 : mild anxiety, between 10 and 14 : moderate anxiety and superior than 15 : significant severe anxiety.	Inclusion
Depression assessment	Depression will be evaluated by PHQ-4 , a self-administered screening tool designed to score anxiety and depression, both of which are significant risk factors for the chronification of pain. The first two items assess anxiety, while the last two assess depression. Each item is scored from 0 to 3 (0 for 'not at all', 1 for 'several days', 2 for 'more than half the days', and 3 for 'nearly every day'). If PHQ-4 score is less than 2 : absence of psychological distress, between 3 and 5 : mild psychological distress, between 6 and 8 : moderate psychological distress and superior than 9 : psychological distress.	Inclusion
Assessment of physical activity and sedentary behavior: IPAQ short form	IPAQ (International Physical Activité Questionnaire) assesses overall physical activity and sedentary behavior over the past seven days. The short version with 7 questions will be used in this study. The minimum value is 0 Metabolic Equivalent of Task (MET) by week for sedentary people. The maximum value is at least 1500 MET by week for intensive active people. This questionnaire allows to assess people's activity and classifies participants into three activity levels: inactive, moderate, and high.	Inclusion
Daytime Sleepiness Assessment	The Epworth Sleepiness Scale is a questionnaire designed to determine or measure daytime sleepiness across eight items. Subjects are asked to rate their frequency (or probability) of falling asleep on a scale of 0 to 3 in eight different situations commonly encountered in daily life. The eight items are summed to obtain a global score ranging from 0 to 24, with higher scores indicating greater sleepiness during common daily activities.	Inclusion
Evaluation of Cardiovascular parameters	Heart rate (HR) in beats per minute will be recorded in a supine position in a quiet room after a 5-minute rest period.	Inclusion
Evaluation of Cardiovascular parameters	Heart rate variability (HRV) will be recorded in a supine position in a quiet room after a 5-minute rest period with an electrocardiogram.	Inclusion
Evaluation of Cardiovascular parameters	Blood pressure (BP) in millimeters of mercury will be recorded in a supine position in a quiet room after a 5-minute rest period with blood pressure monitor.	Inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: TMD; Aerobic Physical Activity; Orofacial myofascial pain
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Stomatognathic Diseases; Muscular Diseases; Joint Diseases; Jaw Diseases; Mandibular Diseases; Craniomandibular Disorders; Temporomandibular Joint Disorders; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: 29BRC25.0313 - AERODOF; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No