Temporomandibular Disorders (TMD)NCT06584526
Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders
A study testing Physical Therapy, Physical Therapy and Aerobic Exercise and Physical Therapy and Strength Exercise in people with Temporomandibular Disorders (TMD) and Nociplastic Pain, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Temporomandibular Disorders (TMD), Nociplastic Pain, Aerobic Exercise
- What is being tested?
- Physical Therapy, Physical Therapy and Aerobic Exercise and Physical Therapy and Strength Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2024to 30 Sep 2025
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
- Chronic pain (\>3months)
- Nociplastic pain
- Positive Flexion Rotation Test
- Be physically able to realize aerobic and strength exercise (functional movement test)
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 month
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Catalonia, 08192
About this study
Official title: Effects of Aerobic and Strength Exercice on Nociplastic Pain in Patients With Temporomandibular Disorders: A Randomized Controlled Trial.
Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention and memory disturbance. The best evidence-based treatment of temporomandibular disorders consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic and strength exercises showed to be effective in subjects with chronic pain and nociplastic pain, by inducing an hypoalgesic effect. However, there isn\'t investigation about the effects of theses types of exercise in subjects with temporomandibular disorders and nociplastic pain. Thus, the aim of the study is to determine if adding aerobic or strength exercise to an effective physical therapy programme is more effective than physical therapy alone to improve nociplastic pain in subjects with temporomandibular disorders.
Read the detailed description
Introduction: Temporomandibular disorders used to improve with education manual therapy and therapeutic exercise. However, despite the evidence oh nociplastic pain in these patients, the treatments remain local. As aerobic and strength exercice have hypoalgesic effect in chronic musculoskeletal pain, we aim to study the effects combined with a common physical therapy programme on nociplastic pain in patients with temporomandibular disorders.
Main objective: Determine if aerobic exercice and strength exercice combined with physical therapy are more effective than physical therapy alone to improve local and remote pressure pain threshold (temporals, masseters, sternocledomastoids, upper trapezius, handgrip, quadriceps and gastrocnemius), in subjects with temporomandibular disorders and nociplastic pain.
Material and methodos:
- Conditions
- Temporomandibular Disorders (TMD), Nociplastic Pain, Aerobic Exercise, Strengthening Exercises, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- Being tested
- Physical Therapy, Physical Therapy and Aerobic Exercise, Physical Therapy and Strength Exercise
- Medical subject headings
- Temporomandibular Joint Disorders, Nociplastic Pain, Temporomandibular Joint Dysfunction Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups).
Physical Therapy and 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 cycle ergometer.
Physical Therapy and Strength ExerciseOther
30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes strength exercise programme.
| Study group | Role | What they receive |
|---|---|---|
| Physical Therapy (PT) | Active comparator | 30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups).
Education: a series of recommendations to correct inappropriate behaviors such as parafunctions.
Manual therapy:
* Bilateral myofascial pressure of 60'' applied to the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles.
* Dorsal glinding of the Occipital-Atlas segment, performed at Grade III intensity (3sets of 30'', with 15'' of rest).
Therapeutic exercise:
* Controlled opening and closing of the jaw: 6 repetitions with 30'' of rest
* Isometric exercices of the jaw in opening, protrusion, and lateral excursion:3 sets of 10'' for each movement, 15'' of rest
* Deep neck flexors training using StabilizerTM biofeedback, without contracting the superficial muscles: baseline pressure at 20 mmHg, perform craniocervical flexion at 22, 24, 26, 28, and 30 mmHg, 10'' per stage). Receives: Other: Physical Therapy |
| Physical Therapy and Aerobic Exercise (PT+AE) | Experimental | Physical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes aerobic exercise programme on a cycle ergometer.
The AE will consist of:
* Warm-up: Participants cycled for 5 min at a heart rate reserve (HRR) of 50%.
* Main work: For 24 min, participants performed an interval exercise divided into four intervals, with 4 min at 85%* of the HRR and 2 min of recovery at 50-60% of the HRR in each cycle.
* Active recovery: The last minute allowed participants to engage in active recovery at 50% of the HRR.
*: The value of the higher HHR will be reached through a weekly progression:
* Week 1: 65% HHR
* Week 2: 70% HHR
* Week 3: 75% HHR
* Week 4: 80% HHR
* Week 5-6: 85% HHR
The HRR was calculated using the Karvonen formula used in similar studies:
HRtarget = [HHR x %intensity] + HRrest
HRR = HRmax - HRrest HRmax = 207 - (0.7 x age)
HR assessed with a Polar10 sensor. Receives: Other: Physical Therapy and Aerobic Exercise |
| Physical Therapy and Strength Exercise (PT+ST) | Experimental | Physical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes strength exercise (ST) programme.
The ST exercise will consist of:
* Warm-up (5'): circuit, 3 sets of: jumping jacks (20''), mountain climbers (20''), abdominal crunch (20''), active stretching of the quadriceps (20'').
* Main work: For 24 min, a circuit of multiarticular exercise (body weight). Four cycles of 4' of work, with 2' of rest between them. Each exercise will have a work time of 30'' guided with a timer. Intensity will be increased each 2 weeks (W) (higher difficulty and speed).
* Lunge: W1-2 bilateral 10x / W3-4 unilateral 12x / W5-6 walking 14x
* Push up: W1-2 inclined 8x / W3-4 normal 10x / W5-6 declined 10x
* Squat: W1-2 normal 10x / W3-4 lateral lunge 12x / W5-6 step up 10x
* Core: W1-2 front plank 10x / W3-4 up and down plank 12x / W5-6 superman 12x
* Active recovery: Walk for 1'. Receives: Other: Physical Therapy and Strength Exercise |
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 6 weeks (final) and 12 weeks (post)
Bilateral measure with digital algometer, applying a perpendicular pressure of 0.5 kg/cm2/s on: masseter, temporal, upper trapezius, SCOM, quadriceps tendon, achilles Tendon.
Measured: Baseline - 6 weeks (final) - 12 weeks
Secondary outcomes (9)
Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (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
Change of baseline in Strength at 6 weeks (final) and 12 weeks (post)
Handgrip strength will be assessed with a Jamar dynamometer, maximal isometric strength, 2 times.
Maximal strength of upper trapezius, quadriceps and gastrocnemius will be assessed with a digital dynamometer ActivForce, maximal isometric strength, 2 times.
Before assessing strength, a 10 minutes warm up of the muscles will be done:
- Upper trapezius: shoulder elevations
- Quadriceps: squat
- Gastrocnemius: heel elevations
- Handgrip: press a ball
Measured: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)
Assessment of upper cervical ROM performing the Flexion Rotation Test with a CROM device.
Measured: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)
Central Sensitization Index: 25 items, from 0 to 100 (0-29=subclinic; 30-39=mild; 40-59=moderate; 60-100=extrem)
Measured: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post)
Patient sitting for 5 minutes to rest, and then heart rate is assessed with a Polar H10 sensor.
Measured: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (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 - 6 weeks (final) - 12 weeks
Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post)
Pittsburgh Sleep Quality Index: maximum score of 21; 5 being the cut-off point.
Measured: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)
Tampa Scale of Kinesiophobia: from 10 to 40 (Likert scale 4 points: 1 = totally disagree; 2 = disagree; 3 = agree; 4 = totally agree). Cut-off: 23.
Measured: Baseline - 6 weeks (final) - 12 weeks
Adherence at 6 weeks (final) and 12 weeks (post)
ATTEMPT questionnaire to evaluate adherence to exercises post-intervention. 6 items, Likert scale 5 punts ( 1 = totally disagree; 2 = disagree; 3 = neutral; 4 = agree; 5 = totally agree). From 6 to 30, a change of 4 indicates a change.
Measured: 6 weeks (final) - 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start9 Sep 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
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
- NCT06584526
- Sponsor's protocol ID
- FIS-2024-05
- Status last verified
- Sep 2024
- First submitted
- 2 Sep 2024
- Last updated
- 29 Apr 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 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic and Strength Exercice on Nociplastic Pain in Patients With Temporomandibular Disorders: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06584526
- Acronym / sponsor ID
- FIS-2024-05
- Conditions
- Temporomandibular Disorders (TMD), Nociplastic Pain, Aerobic Exercise, Strengthening Exercises, Myofascial Pain Dysfunction Syndrome, Temporomandibular Joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Sep 2024 (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.
Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention and memory disturbance. The best evidence-based treatment of temporomandibular disorders consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic and strength exercises showed to be effective in subjects with chronic pain and nociplastic pain, by inducing an hypoalgesic effect. However, there isn\'t investigation about the effects of theses types of exercise in subjects with temporomandibular disorders and nociplastic pain. Thus, the aim of the study is to determine if adding aerobic or strength exercise to an effective physical therapy programme is more effective than physical therapy alone to improve nociplastic pain in subjects with temporomandibular disorders.
Detailed description
Introduction: Temporomandibular disorders used to improve with education manual therapy and therapeutic exercise. However, despite the evidence oh nociplastic pain in these patients, the treatments remain local. As aerobic and strength exercice have hypoalgesic effect in chronic musculoskeletal pain, we aim to study the effects combined with a common physical therapy programme on nociplastic pain in patients with temporomandibular disorders.
Main objective: Determine if aerobic exercice and strength exercice combined with physical therapy are more effective than physical therapy alone to improve local and remote pressure pain threshold (temporals, masseters, sternocledomastoids, upper trapezius, handgrip, quadriceps and gastrocnemius), in subjects with temporomandibular disorders and nociplastic pain.
Material and methodos:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical Therapy (PT) | Active comparator | Other: Physical Therapy30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups). Education: a series of recommendations to correct inappropriate behaviors such as parafunctions. Manual therapy: * Bilateral myofascial pressure of 60'' applied to the masseter, temporalis, sternocleidomastoid, and upper trapezius muscles. * Dorsal glinding of the Occipital-Atlas segment, performed at Grade III intensity (3sets of 30'', with 15'' of rest). Therapeutic exercise: * Controlled opening and closing of the jaw: 6 repetitions with 30'' of rest * Isometric exercices of the jaw in opening, protrusion, and lateral excursion:3 sets of 10'' for each movement, 15'' of rest * Deep neck flexors training using StabilizerTM biofeedback, without contracting the superficial muscles: baseline pressure at 20 mmHg, perform craniocervical flexion at 22, 24, 26, 28, and 30 mmHg, 10'' per stage). |
| Physical Therapy and Aerobic Exercise (PT+AE) | Experimental | Other: Physical Therapy and Aerobic ExercisePhysical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes aerobic exercise programme on a cycle ergometer. The AE will consist of: * Warm-up: Participants cycled for 5 min at a heart rate reserve (HRR) of 50%. * Main work: For 24 min, participants performed an interval exercise divided into four intervals, with 4 min at 85%* of the HRR and 2 min of recovery at 50-60% of the HRR in each cycle. * Active recovery: The last minute allowed participants to engage in active recovery at 50% of the HRR. *: The value of the higher HHR will be reached through a weekly progression: * Week 1: 65% HHR * Week 2: 70% HHR * Week 3: 75% HHR * Week 4: 80% HHR * Week 5-6: 85% HHR The HRR was calculated using the Karvonen formula used in similar studies: HRtarget = [HHR x %intensity] + HRrest HRR = HRmax - HRrest HRmax = 207 - (0.7 x age) HR assessed with a Polar10 sensor. |
| Physical Therapy and Strength Exercise (PT+ST) | Experimental | Other: Physical Therapy and Strength ExercisePhysical therapy combined with aerobic exercise: 30 minutes of physical therapy (same programme than the other experimental group and the active comparator), combined with a 30 minutes strength exercise (ST) programme. The ST exercise will consist of: * Warm-up (5'): circuit, 3 sets of: jumping jacks (20''), mountain climbers (20''), abdominal crunch (20''), active stretching of the quadriceps (20''). * Main work: For 24 min, a circuit of multiarticular exercise (body weight). Four cycles of 4' of work, with 2' of rest between them. Each exercise will have a work time of 30'' guided with a timer. Intensity will be increased each 2 weeks (W) (higher difficulty and speed). * Lunge: W1-2 bilateral 10x / W3-4 unilateral 12x / W5-6 walking 14x * Push up: W1-2 inclined 8x / W3-4 normal 10x / W5-6 declined 10x * Squat: W1-2 normal 10x / W3-4 lateral lunge 12x / W5-6 step up 10x * Core: W1-2 front plank 10x / W3-4 up and down plank 12x / W5-6 superman 12x * Active recovery: Walk for 1'. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
- Chronic pain (\>3months)
- Nociplastic pain
- Positive Flexion Rotation Test
- Be physically able to realize aerobic and strength exercise (functional movement test)
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 Therapy30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions (same programme than the experimental groups). | Other | Physical Therapy (PT) |
| Physical Therapy and 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 cycle ergometer. | Other | Physical Therapy and Aerobic Exercise (PT+AE) |
| Physical Therapy and Strength Exercise30 minutes of physical therapy with education, manual therapy and therapeutic exercise at both temporomandibular and cervical regions, combined with a 30 minutes strength exercise programme. | Other | Physical Therapy and Strength Exercise (PT+ST) |
Primary outcome
Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Bilateral measure with digital algometer, applying a perpendicular pressure of 0.5 kg/cm2/s on: masseter, temporal, upper trapezius, SCOM, quadriceps tendon, achilles Tendon.
9 secondary outcomes
Change of baseline in Jaw function at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 1 month (final) - 3 months
Change of baseline in Strength at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Upper Cervical ROM at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Central Sensitization at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Rest Heart Rate at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Anxiety and depression at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Sleep Quality at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Change of baseline in Kinesiophobia at 6 weeks (final) and 12 weeks (post)
Time frame: Baseline - 6 weeks (final) - 12 weeks
Adherence at 6 weeks (final) and 12 weeks (post)
Time frame: 6 weeks (final) - 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, Physical Therapy and Aerobic Exercise and Physical Therapy and Strength Exercise in people with Temporomandibular Disorders (TMD) and Nociplastic Pain, 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 5 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: finished, as of the sponsor's last update on 29 Apr 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of baseline in Pain Pressure Threshold at 6 weeks (final) and 12 weeks (post) (time frame: Baseline - 6 weeks (final) - 12 weeks). 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 29 Apr 2026.