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.
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.
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- 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.
Marie ORLIAGUET contact
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
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.
- Conditions
- Temporomandibular Disorders (TMD)
- 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 group | Role | What they receive |
|---|---|---|
| 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. 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.
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)
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
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
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
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
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
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
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
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
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.
- First posted13 Apr 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorders (TMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aerobic Physical Activity and Orofacial Myofascial Pain
- ClinicalTrials.gov ID
- NCT07526688
- Acronym / sponsor ID
- AERODOF / 29BRC25.0313 - AERODOF
- Conditions
- Temporomandibular Disorders (TMD)
- Keywords
- Orofacial myofascial pain, TMD, Aerobic Physical Activity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation of the chronic orofacial pain | Other | Other: Temporal Summation of Pain and QuestionnaireAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- Diagnosis of painful Temporomandibular Disorder (TMD) according to the DC/TMD (Diagnostic Criteria for TMD) clinical standards.
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Temporal Summation of Pain and QuestionnaireAll 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 | Other | Evaluation of the chronic orofacial pain |
Primary outcome
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).
9 secondary outcomes
Temporal summation at the forearm muscle
Time frame: Inclusion
Referred sensations at the Masseter muscle
Time frame: Inclusion
Anxiety assessment
Time frame: Inclusion
Depression assessment
Time frame: Inclusion
Assessment of physical activity and sedentary behavior: IPAQ short form
Time frame: Inclusion
Daytime Sleepiness Assessment
Time frame: Inclusion
Evaluation of Cardiovascular parameters
Time frame: Inclusion
Evaluation of Cardiovascular parameters
Time frame: Inclusion
Evaluation of Cardiovascular parameters
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie ORLIAGUET contact
1 site in 1 country: see every site and its status.
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.