Temporomandibular DisorderNCT05540366
Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization
A study testing Physical therapy combined with aerobic exercise and Physical Therapy in people with Temporomandibular Disorder and Central Sensitisation, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorder, Central Sensitisation, Myofascial Pain Syndrome
- What is being tested?
- Physical therapy combined with aerobic exercise and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
- A minimum score of 30 in the Central Sensitization Index
- Positive FRT
Who cannot join
- History of trauma, TMJ or cervical fracture the past three months
- History of TMJ or cervical surgery
- Systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant
- History of cardiovascular diseases which contraindicate aerobic exercise
- Current orthodontic treatment, splints for bruxism
- Drug addiction, alcoholism
Show all 9Show fewer
- Pregnancy
- Use of analgesic medication less than 48 hours before each data collection
- Physical therapy treatment during the past three months
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès
Flora Dantony
About this study
Official title: Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial
Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. The best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. However, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. Thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.
- Conditions
- Temporomandibular Disorder, Central Sensitisation, Myofascial Pain Syndrome, Endurance Training
- Being tested
- Physical therapy combined with aerobic exercise, Physical Therapy
- Medical subject headings
- Temporomandibular Joint Disorders, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy combined with aerobic exerciseOther
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike.
Physical TherapyOther
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group)
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Myogenous temporomandibular subjects
Physical therapy combined with aerobic exercise: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike. Receives: Other: Physical therapy combined with aerobic exercise |
| Control group | Active comparator | Myogenous temporomandibular subjects
Physical Therapy: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group) Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)
Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon
Measured: Baseline - 2 weeks - 1 month (final) - 3 months
Secondary outcomes (10)
Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)
Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Measured: Baseline - 2 weeks - 1 month (final) - 3 months post
Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)
Visual Analog Scale: 100mm (no pain to worst pain)
Measured: Baseline - 2 weeks - 1 month (final) - 3 months posts
Change of baseline in Jaw function at 1 month (final) and 3 months (post)
Fonseca Anamnestic Index. 10 questions with a three-point scale: 0 = no, 5 = sometimes and 10 = yes; total score from 0 good function, to 100 worst.
Measured: Baseline - 1 month (final) - 3 months post
Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)
Millimeter metalic rule to assess opening, lateral and protrusion jaw range of motion
Measured: Baseline - 1 month (final) - 3 months posts
Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)
CROM for global cervical range (flexion, extension, rotations, inclinations)
Measured: Baseline - 1 month (final) - 3 months post
Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)
Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device
Measured: Baseline - 2 weeks - 1 month (final) - 3 months posts
Change of baseline in Neck disability at 1 month (final) and 3 months (post)
Neck Disability Index: from 0 to 50 (0-4= no disability; 5-14=mild; 15-24=moderate; 25-34=severe; 35-50=complete)
Measured: Baseline - 1 month (final) - 3 months posts
Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)
Hospital Anxiety and Depression Scale: 2 subscales, one for anxiety and the other one for depression. Each scale score is from 0 (less) to 21 (worst)
Measured: Baseline - 1 month (final) - 3 months posts
Change of baseline in Sleep Quality at 1 month (final) and 3 months (post)
Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Measured: Baseline - 1 month (final) - 3 months posts
Change of baseline in Perceived change at 1 month (final) and 3 months (post)
Global Rating of Change scale: 15 points, from -7 (worst) to 7 (best)
Measured: Baseline - 1 month (final) - 3 months posts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start1 Dec 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flora Dantony, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540366
- Sponsor's protocol ID
- Flora Dantony
- Status last verified
- Jan 2023
- First submitted
- 6 Sep 2022
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05540366
- Acronym / sponsor ID
- Flora Dantony
- Conditions
- Temporomandibular Disorder, Central Sensitisation, Myofascial Pain Syndrome, Endurance Training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 14 Sep 2022 (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.
Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. The best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. However, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. Thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Physical therapy combined with aerobic exerciseMyogenous temporomandibular subjects Physical therapy combined with aerobic exercise: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike. |
| Control group | Active comparator | Other: Physical TherapyMyogenous temporomandibular subjects Physical Therapy: 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
- A minimum score of 30 in the Central Sensitization Index
- Positive FRT
Key exclusion criteria (9 listed)
- History of trauma, TMJ or cervical fracture the past three months
- History of TMJ or cervical surgery
- Systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant
- History of cardiovascular diseases which contraindicate aerobic exercise
- Current orthodontic treatment, splints for bruxism
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 |
|---|---|---|
| Physical therapy combined with aerobic exercise30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes aerobic exercise programme on a bike. | Other | Intervention Group |
| Physical Therapy30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the intervention group) | Other | Control group |
Primary outcome
Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)
Time frame: Baseline - 2 weeks - 1 month (final) - 3 months
Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon
10 secondary outcomes
Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)
Time frame: Baseline - 2 weeks - 1 month (final) - 3 months post
Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)
Time frame: Baseline - 2 weeks - 1 month (final) - 3 months posts
Change of baseline in Jaw function at 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months post
Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months posts
Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months post
Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)
Time frame: Baseline - 2 weeks - 1 month (final) - 3 months posts
Change of baseline in Neck disability at 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months posts
Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months posts
Change of baseline in Sleep Quality at 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months posts
Change of baseline in Perceived change at 1 month (final) and 3 months (post)
Time frame: Baseline - 1 month (final) - 3 months posts
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy combined with aerobic exercise and Physical Therapy in people with Temporomandibular Disorder and Central Sensitisation, run by Universitat Internacional de Catalunya at 1 site in Spain.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 27 Jan 2023. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flora Dantony (+34601533951, fdantony@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post) (time frame: Baseline - 2 weeks - 1 month (final) - 3 months). 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 27 Jan 2023.