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NCT Number: NCT07526688

Aerobic Physical Activity and Orofacial Myofascial Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

  1. Temporal summation at the forearm muscle

    Time frame: Inclusion

    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.

  2. Referred sensations at the Masseter muscle

    Time frame: Inclusion

    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

  3. Anxiety assessment

    Time frame: Inclusion

    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.

  4. Depression assessment

    Time frame: Inclusion

    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.

  5. Assessment of physical activity and sedentary behavior: IPAQ short form

    Time frame: Inclusion

    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.

  6. Daytime Sleepiness Assessment

    Time frame: Inclusion

    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.

  7. Evaluation of Cardiovascular parameters

    Time frame: Inclusion

    Heart rate (HR) in beats per minute will be recorded in a supine position in a quiet room after a 5-minute rest period.

  8. Evaluation of Cardiovascular parameters

    Time frame: Inclusion

    Heart rate variability (HRV) will be recorded in a supine position in a quiet room after a 5-minute rest period with an electrocardiogram.

  9. Evaluation of Cardiovascular parameters

    Time frame: Inclusion

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anais LE FUR-BONNABESSE, MD

CONTACT

[email protected]

0298223330

Marie ORLIAGUET

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Acronym: AERODOF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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