TMDNCT05003349
Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders.
A study testing Occlusal Splint (OS)., Pain Neuroscience Education (PNE). and Motor Imagery (MI). in people with TMD, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
The objective of this study will be to verify the additional effect of Pain Neuroscience Education, Motor Imagery and Action Observation on primary outcomes pain intensity and craniofacial pain and disability in patients with chronic temporomandibular disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- TMD
- What is being tested?
- Occlusal Splint (OS)., Pain Neuroscience Education (PNE). and Motor Imagery (MI).
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- 31 Aug 2021to 12 Jan 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of painful TMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- A history of orofacial pain during at least three months prior to the study
- Age ranging between 18 to 65 years, both genders.
Who cannot join
- Patients with neurological disorders (neuropathic pain or neurodegenerative disease), whiplash associated disorders, specific neck pain (radicular pain), recent dental or physical therapy. If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Effect of Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders. A Randomized Controlled Trial
The objective of this study will be to verify the additional effect of Pain Neuroscience Education, Motor Imagery and Action Observation on primary outcomes pain intensity and craniofacial pain and disability in patients with chronic temporomandibular disorders (TMD). The secondary outcomes will be pressure pain threshold, temporal summation, conditioned pain modulation, central sensibilization, pain catastrophizing, kinesiophobia. This study will be a doble-blinded randomized clinical trial comprising a sample of 50 participants with orofacial pain of both genders and aged between 18 and 60 years. Subjects will undergo a screening process to identify those presenting a diagnosis of painful TMD confirmed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), and then they will be randomized into two groups (G1: Occlusal Splint, Counselling and Jaw and Neck Exercises vs. (G2: Occlusal Splint, Jaw and Neck Exercises plus Pain Neuroscience Education, Motor Imagery and Action Observation). These volunteers will be recruited from the Alisos Group Dentistry Clinic and University of Gran Rosario, (Rosario, Argentina). All patients will wear an occlusal splint designed by dentists. The interventions will be administered twice a week for 5 weeks by a single therapist. Subsequently, patients will be given instructions to perform the exercises at home for 5 weeks. Primary and secondary outcomes will be measured at baseline, 6 weeks and 12 weeks, and at 3 months after the end of treatment (follow-up). All the evaluations will be performed by a blinded physiotherapist.
- Conditions
- TMD
- Being tested
- Occlusal Splint (OS)., Pain Neuroscience Education (PNE)., Motor Imagery (MI)., Action Observation (AO)., Jaw and Neck Exercises (JNE)
- Keywords
- Pain Neuroscience Education, Motor Imagery, Action Observation, Exercises, Occlusal Splint
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal Splint (OS).Other
OS will be made of heat-cured acrylic by the same specialized dentist. These intraoral devices will be flate, rigid, will cover the entire dental arch, and will have the lowest possible height. The perimeter of the splint will have at least 11 dental contacts, light, symmetrical and pinpoint as possible. The patients will be instructed to use the splint every night during the study Two supervisions will be carried out 30 and 60 days after the use of the OS, in order to stabilize the contact points.
Pain Neuroscience Education (PNE).Other
A power point presentation with metaphors and animated videos will be used. The PNE will be held in 10 sessions of 20 minutes each. The intervention will be developed using content according to the book "Explain Pain" and the web page www.retrainpain.org.
Motor Imagery (MI).Other
The participants will have to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The procedure will begin with a familiarization test with the "Basic" level followed by a laterality discrimination task. It will be performed using 20 images, with 5 seconds for each image, beginning with the "Vanilla" program and progressively increasing the difficulty using the "Context" and "Abstract" programs. The estimated time to complete the task will be about 10 minutes per session.
Action Observation (AO).Other
The patients will see videos showing the jaw and cervical exercises with the same series and repetitions that they will actively perform in the session. Therefore, the training of the action observation will be carried out dynamically. The patient will be asked to think and visualize the movement that he/she will have to perform later. It is estimated 10 minutes per session for the AO.
Jaw and Neck Exercises (JNE)Other
A jaw and neck exercise program will be carried out in 3 series of 10 repetitions per session will be planned with 1minute rest between exercise. The exercises will be executed with a total time per session of 20 minutes, initially in the clinic and later at home. In the clinic, verbal and tactile instructions will be provided for the correct execution of the exercises and later they will be sent through WhatsApp and / or mail to perform them at home.
Counselling.Other
Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Occlusal Splint (OS) + Pain Neuroscience Education (PNE) + Motor Imagery (MI) + Action Observation (AO) + Jaw and Neck Exercises (JNE) All participants in this arm will receive OS (they must use every night during the study) and will receive physiotherapy treatment including PNE, MI, AO and JNE, in 2 sessions per week, each lasting 60 minutes, during 5 weeks. For PNE a power-point presentation with metaphors, images and videos will be employed. For the MI, the participants will be asked to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The AO will be carried out using videos of mandibular and cervical exercises. The JNE program will be performed 3 sets of 10 repetitions. The exercises will be executed with a total time per session of 20 minutes, initially at the clinic and later at home. Receives: Other: Occlusal Splint (OS).; Other: Pain Neuroscience Education (PNE).; Other: Motor Imagery (MI).; Other: Action Observation (AO).; Other: Jaw and Neck Exercises (JNE) |
| Active comparator | Active comparator | Occlusal Splint (OS) + Counselling + Jaw and Neck Exercises (JNE). All participants in this arm will receive OS and will receive physiotherapy treatment including Counselling and JNE, in 2 sessions per week, each lasting 40 minutes, during 5 weeks. The JNE will be administered in the same way as in the other arm of the study.
Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth). Receives: Other: Occlusal Splint (OS).; Other: Jaw and Neck Exercises (JNE); Other: Counselling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain intensity.
The Numerical Pain Rating Scale (NPRS) will be used to assess pain intensity. This scale consists in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up.
Change in Craneofacial pain and disability inventory.
The Craneofacial pain and disability inventory (CF-PDI) is a self-administered questionnaire that has been designed to obtain information on how pain in the orofacial region affects the patient's daily life. It consists of 21 items, with the final score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher pain and disability levels.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up.
Secondary outcomes (7)
Change in Pressure Pain Threshold.
The Pressure Pain Threshold (PPT) will be measured through a pressure algometer in 3 different sites; 1) Anterior temporalis muscle, 2) upper trapezius muscle and 3) thenar eminence (non-dominant hand). At each site, 3 measurements will be made with an interval of 30 seconds, and the mean will be registered. To determine the PPT, the pressure will be increased at a rate of approximately 1 kg/second and patients will be asked to raise their arm the moment the pressure begins to change to a sensation of pain, at which point, the evaluator will stop pressing. PPT values will be expressed in kg/cm2.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Temporal Summation.
Temporal Summation (TS) will be induced using a pressure algometer. For TS, 10 consecutive pressure pulses will be elicited using the PPT (obtained before). For each pulse of the TS procedure, the pressure will increase at a rate of 1 kg/second until the PPT is reached, where it will remain for one second before being released. The pressure pulses will be repeatedly performed with an interval between stimuli of one second. Participants will be instructed to assess the pain intensity of the first and tenth pressure pulses according to the NPRS. The TS score will be obtained by subtracting the first NPRS score from the last score. The higher the TS score, the more efficient nociceptive signaling for the brain.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Conditioned Pain Modulation.
For the Conditioned Pain Modulation (CPM) a occlusion cuff will be used as a conditioning stimulus. The cuff will be inflated in the non-dominant arm at approximately 20 mm Hg/second until the subjects report experiencing pain at a value of 5/10 using the NPRS, when inflation will stop. Subjects will adapt to the stimulus for 30 seconds, and the first PPT measurement will be performed. Then, the cuff will then be deflated and 1 minute later the second PPT measurement will be taken.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Central Sensibilization Inventory.
The Central Sensibilization Inventory (CSI) is a self-report outcome measure that consists of two parts. Part A consists of 25 statements where the participant must answer how often he/she experience each symptom. Individual items are scored from "0" (never) to "4" (always), resulting in a total score range for all 25 items from "0" to "100". Part B asks if the participant have been previously diagnosed by a doctor for some diseases (YES/NO). Part B of the CSI is for information only and is not qualified. A score of more than 40 indicates the presence of central sensitization.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Pain Catastrophizing Scale
The Pain Catastrophizing scale (PCS) is a 13-items instrument that ask participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points being (0) not at all and, (4) all the time. A total score (ranging from 0 to 52) is obtained, along with three subscale scores that assess rumination, magnification, and helplessness. A higher total PCS score of 30 represents a clinically relevant level of catastrophizing.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders
The Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular Disorders (TSK-TMD-S) consists of 10 items formulated positively and distributed in 2 subscales as follows: (1) somatic approach (items 1, 2, 3, 4 and 10) and (2) avoidance of activities (items 5 to 9). The total score can range from 10 to 40 (somatic focus, 5-20; avoidance of activity, 5-20), with higher scores indicating an increased fear of jaw movement and re-injury. The cut-off point to consider kinesiophobia is 23 points.
Measured: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Home exercise adherence
To assess adherence to home exercise, a google form will be sent weekly to the volunteers. It will consist of questions related to the number of times patients performed the exercises during the week and to the difficulties they encountered. Adherence to exercises will be expressed as a percentage [(number of exercise sessions performed / number of exercise sessions prescribed) X100].
Measured: Between the sixth and twelfth week (once per week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start31 Aug 2021
- Primary completion30 Nov 2025
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TMDStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Barone, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003349
- Sponsor's protocol ID
- PNE, MI and AO in TMD
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- 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 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Effect of Pain Neuroscience Education, Motor Imagery and Action Observation in Patients With Chronic Temporomandibular Disorders. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05003349
- Acronym / sponsor ID
- PNE, MI and AO in TMD
- Conditions
- TMD
- Keywords
- Pain Neuroscience Education, Motor Imagery, Action Observation, Exercises, Occlusal Splint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 12 Aug 2021 (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.
The objective of this study will be to verify the additional effect of Pain Neuroscience Education, Motor Imagery and Action Observation on primary outcomes pain intensity and craniofacial pain and disability in patients with chronic temporomandibular disorders (TMD). The secondary outcomes will be pressure pain threshold, temporal summation, conditioned pain modulation, central sensibilization, pain catastrophizing, kinesiophobia. This study will be a doble-blinded randomized clinical trial comprising a sample of 50 participants with orofacial pain of both genders and aged between 18 and 60 years. Subjects will undergo a screening process to identify those presenting a diagnosis of painful TMD confirmed by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), and then they will be randomized into two groups (G1: Occlusal Splint, Counselling and Jaw and Neck Exercises vs. (G2: Occlusal Splint, Jaw and Neck Exercises plus Pain Neuroscience Education, Motor Imagery and Action Observation). These volunteers will be recruited from the Alisos Group Dentistry Clinic and University of Gran Rosario, (Rosario, Argentina). All patients will wear an occlusal splint designed by dentists. The interventions will be administered twice a week for 5 weeks by a single therapist. Subsequently, patients will be given instructions to perform the exercises at home for 5 weeks. Primary and secondary outcomes will be measured at baseline, 6 weeks and 12 weeks, and at 3 months after the end of treatment (follow-up). All the evaluations will be performed by a blinded physiotherapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Occlusal Splint (OS)., Other: Pain Neuroscience Education (PNE)., Other: Motor Imagery (MI)., Other: Action Observation (AO)., Other: Jaw and Neck Exercises (JNE)Occlusal Splint (OS) + Pain Neuroscience Education (PNE) + Motor Imagery (MI) + Action Observation (AO) + Jaw and Neck Exercises (JNE) All participants in this arm will receive OS (they must use every night during the study) and will receive physiotherapy treatment including PNE, MI, AO and JNE, in 2 sessions per week, each lasting 60 minutes, during 5 weeks. For PNE a power-point presentation with metaphors, images and videos will be employed. For the MI, the participants will be asked to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The AO will be carried out using videos of mandibular and cervical exercises. The JNE program will be performed 3 sets of 10 repetitions. The exercises will be executed with a total time per session of 20 minutes, initially at the clinic and later at home. |
| Active comparator | Active comparator | Other: Occlusal Splint (OS)., Other: Jaw and Neck Exercises (JNE), Other: Counselling.Occlusal Splint (OS) + Counselling + Jaw and Neck Exercises (JNE). All participants in this arm will receive OS and will receive physiotherapy treatment including Counselling and JNE, in 2 sessions per week, each lasting 40 minutes, during 5 weeks. The JNE will be administered in the same way as in the other arm of the study. Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of painful TMD using the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)
- A history of orofacial pain during at least three months prior to the study
- Age ranging between 18 to 65 years, both genders.
Key exclusion criteria (1 listed)
- Patients with neurological disorders (neuropathic pain or neurodegenerative disease), whiplash associated disorders, specific neck pain (radicular pain), recent dental or physical therapy. If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
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 |
|---|---|---|
| Occlusal Splint (OS).OS will be made of heat-cured acrylic by the same specialized dentist. These intraoral devices will be flate, rigid, will cover the entire dental arch, and will have the lowest possible height. The perimeter of the splint will have at least 11 dental contacts, light, symmetrical and pinpoint as possible. The patients will be instructed to use the splint every night during the study Two supervisions will be carried out 30 and 60 days after the use of the OS, in order to stabilize the contact points. | Other | Active comparator, Experimental group |
| Pain Neuroscience Education (PNE).A power point presentation with metaphors and animated videos will be used. The PNE will be held in 10 sessions of 20 minutes each. The intervention will be developed using content according to the book "Explain Pain" and the web page www.retrainpain.org. | Other | Experimental group |
| Motor Imagery (MI).The participants will have to judge the laterality of different cervical images presented on the screen of a cell phone. The laterality task will be executed using an application called Recognize Neck, developed by the NOI group. The procedure will begin with a familiarization test with the "Basic" level followed by a laterality discrimination task. It will be performed using 20 images, with 5 seconds for each image, beginning with the "Vanilla" program and progressively increasing the difficulty using the "Context" and "Abstract" programs. The estimated time to complete the task will be about 10 minutes per session. | Other | Experimental group |
| Action Observation (AO).The patients will see videos showing the jaw and cervical exercises with the same series and repetitions that they will actively perform in the session. Therefore, the training of the action observation will be carried out dynamically. The patient will be asked to think and visualize the movement that he/she will have to perform later. It is estimated 10 minutes per session for the AO. | Other | Experimental group |
| Jaw and Neck Exercises (JNE)A jaw and neck exercise program will be carried out in 3 series of 10 repetitions per session will be planned with 1minute rest between exercise. The exercises will be executed with a total time per session of 20 minutes, initially in the clinic and later at home. In the clinic, verbal and tactile instructions will be provided for the correct execution of the exercises and later they will be sent through WhatsApp and / or mail to perform them at home. | Other | Active comparator, Experimental group |
| Counselling.Counselling include education about the anatomical, biomechanical and psychosocial factors relationed with temporomandibular disorders, guidance regarding the parafunction jaw activities for eg will be taught the resting postural position of the mandible (teeth apart, lips slightly touching and tongue not pushing against the teeth). | Other | Active comparator |
Primary outcome
Change in Pain intensity.
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up.
The Numerical Pain Rating Scale (NPRS) will be used to assess pain intensity. This scale consists in a sequence of numbers from 0 to 10, in which 0 represents "no pain" and 10 represents "worst pain imaginable".
Change in Craneofacial pain and disability inventory.
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up.
The Craneofacial pain and disability inventory (CF-PDI) is a self-administered questionnaire that has been designed to obtain information on how pain in the orofacial region affects the patient's daily life. It consists of 21 items, with the final score ranging from 0 to 63 points. Each question is scored on a 4-point ordinal scale, ranging from 0 to 3. A higher score reflects higher pain and disability levels.
7 secondary outcomes
Change in Pressure Pain Threshold.
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Temporal Summation.
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Conditioned Pain Modulation.
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Central Sensibilization Inventory.
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Pain Catastrophizing Scale
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Spanish version of the Tampa Scale of Kinesiophobia for Temporomandibular. Disorders
Time frame: At baseline, then at six, twelve weeks, and 3 months follow-up
Change in Home exercise adherence
Time frame: Between the sixth and twelfth week (once per week)
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 15 Jan 2026.
- 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.
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 Occlusal Splint (OS)., Pain Neuroscience Education (PNE). and Motor Imagery (MI). in people with TMD, run by University of Gran Rosario at 1 site in Argentina.
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 1 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 15 Jan 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 Argentina. 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 in Pain intensity. (time frame: At baseline, then at six, twelve weeks, and 3 months follow-up.). The study lists 2 primary outcomes in all. 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 15 Jan 2026.