ClinicalTrials.gg
Not yet recruitingNCT07526688AERODOFUpdated Jul 9, 2026

Aerobic Physical Activity and Orofacial Myofascial Pain

An interventional study of Temporal Summation of Pain and Questionnaire in Temporomandibular Disorders (TMD), sponsored by University Hospital, Brest. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-09.

Sponsored by University Hospital, Brest · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Temporomandibular Joint Disorders with a site in France — 3 open to participants now, 3 under way, none of them phase 3. Temporomandibular Joint Disorders · France.

Started
2026
with 1 other
No phase
7 of 11
3 open now
Registered
11th of 11
by date
Lead sponsor
1 of 11
University Hospital, Brest

Among the 11 studies in Temporomandibular Joint Disorders with a site in France, this one is one of 2 that started in 2026, is one of 7 with no phase, and was the 11th registered.

Temporomandibular Joint Disorders

591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.

Browse Temporomandibular Joint Disorders studies →

Open to participants now

3 of the 11 studies in Temporomandibular Joint Disorders with a site in France are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 75 Temporomandibular Joint Disorders studies recruiting now, 26 (35%) set no upper age limit and 45 (60%) stop at 75 or younger; 7 take children under 18; 23 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Temporomandibular Joint Disorders with a site in France, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • Temporomandibular Disorders (TMD)

Keywords

  • Orofacial myofascial pain
  • TMD
  • Aerobic Physical Activity
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .
  • 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

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • 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

Interventions

  • OtherTemporal 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

06

What researchers measure

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).

    Time frame: Inclusion

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Inclusion

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

Of 242 non-industry interventional studies with no phase under Temporomandibular Joint Disorders, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 21. This study's planned 24 months is above that.

Counting every sponsor, half of 246 studies reached it within 10 months; a quarter within 5 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2026
First posted
Apr 13, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Sep 1, 2028
CompletionEst.
Sep 1, 2028
Last update
Jul 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07526688
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Sep 1, 2028 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jul 9, 2026

Study contacts

Anais LE FUR-BONNABESSE, MD
Contact
Anais.lefur-bonnabesse@chu-brest.fr
0298223330
Marie ORLIAGUET
Contact
marie.orliaguet@chu-brest.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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