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Temporomandibular Disorders (TMD)AERODOFNCT07526688

Aerobic Physical Activity and Orofacial Myofascial Pain

A study testing Temporal Summation of Pain and Questionnaire in people with Temporomandibular Disorders (TMD), run by University Hospital, Brest at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Orofacial myofascial pain, most commonly represented by Temporomandibular Disorders (TMD) a significant public health, affecting approximately 12% to 14% of the general population. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Temporomandibular Disorders (TMD)
What is being tested?
Temporal Summation of Pain and Questionnaire
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteFrance
Study dates
1 Sep 2026to 1 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Anais LE FUR-BONNABESSE, MD contact

0298223330

Anais.lefur-bonnabesse@chu-brest.fr

Marie ORLIAGUET contact

marie.orliaguet@chu-brest.fr

France1 site
  • LE FUR-BONNABESSE Anaïs

    Brest

    Anaïs LE FUR-BONNABESSE, Dr, 0298223330, anais.lefurbonnabesse@univ-brest.fr

    Marie ORLIAGUET, Dr, marie.orliaguet@chu-brest.fr

Other trials in France

About this study

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.

Read more

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.

Read the 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.

Being tested
Temporal Summation of Pain and Questionnaire
Keywords
Orofacial myofascial pain, TMD, Aerobic Physical Activity
Medical subject headings
Temporomandibular Joint Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Temporal Summation of Pain and QuestionnaireOther

    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
Study groups in NCT07526688
Study groupRoleWhat they receive
Evaluation of the chronic orofacial painOtherAll 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.
Receives: Other: Temporal Summation of Pain and Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Inclusion

Secondary outcomes (9)
  1. 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.

    Measured: Inclusion

  2. 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

    Measured: Inclusion

  3. 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.

    Measured: Inclusion

  4. 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.

    Measured: Inclusion

  5. 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.

    Measured: Inclusion

  6. 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.

    Measured: Inclusion

  7. 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.

    Measured: Inclusion

  8. 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.

    Measured: Inclusion

  9. 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.

    Measured: Inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07526688
Sponsor's protocol ID
29BRC25.0313 - AERODOF
Other IDs
IDRCB
Acronym
AERODOF
Status last verified
Jul 2026
First submitted
2 Apr 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Temporal Summation of Pain and Questionnaire in people with Temporomandibular Disorders (TMD), run by University Hospital, Brest at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anais LE FUR-BONNABESSE, MD (0298223330, Anais.lefur-bonnabesse@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain facilitation profile : masseter muscle (time frame: Inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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