Temporomandibular Joint DysfunctionNCT04122352
The Effects of Trigger Point Treatment in Temporomandibular Joint Dysfunction
A study testing Ischemic compression and Exercises (Rocabodo's 6x6 exercises and posture exercises) in people with Temporomandibular Joint Dysfunction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, range of motion(ROM), pain pressure threshold (PPT) and functionality on patient with temporomandibular joint dysfunction.(TMD) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Temporomandibular Joint Dysfunction
- What is being tested?
- Ischemic compression and Exercises (Rocabodo's 6x6 exercises and posture exercises)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2019to 15 Mar 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of TMD according to the criteria of DC / TMD (Diagnostic Criteria for Temporomandibular Disorders)
- Detection of trigger point during palpation of masticatory muscles
- Volunteer to participate in the study
Who cannot join
- To have undergone TMJ or cervical surgery and have been treated from these regions in the last 3 months
- Presence of rheumatic disease including TMJ
- Patients with TMJ instability or fractures
- Cases with cognitive impairment
- Presence of chronic pain such as trigeminal neuralgia
- Cases who do not regularly participate in treatment are excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Aydin University
Istanbul, Bakırköy / Florya, 34153
About this study
Official title: The Effects of Trigger Point Treatment on Pain and Functionality in Temporomandibular Joint Dysfunction
The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, range of motion(ROM), pain pressure threshold (PPT) and functionality on patient with temporomandibular joint dysfunction.(TMD)
Read the detailed description
TMD is most common of pain and functional limitations of jaw. The ischemic compression and the exercises (Rocabado's 6x6 exercises and posture exercises) each relieve pain and increase funcitonality on TMD but which one has the more effect should be investigated.
The ROCABODO's 6x6 exercise program, which is a special for temporomandibular joint, includes repetitive movements that include patient education, patient self-care, lifestyle modifications, and recognizing which actions have the effect of increasing the symptoms of an individual's active participation. The repetitive movements relax the chewing muscles and reduce pain by helping the synovial fluid move along the joint surfaces, increasing circulation, removing joint nutrition, and removing the metabolites of articular cartilage.
Postural exercise is commonly used for pain/tension in neck or back, but can also be applied in the orofacial region, aiming to relief muscle symptoms such as pain, tension, stiffness, and tiredness ,by improving the position of the head or the mandibular. It is believed that wrong head position can cause muscle pain due to acceleration of muscle activity in the neck and jaw muscles, as well as postural reflex. Postural exercise includes head posture correction and myofascial release.
Ischemic compression, that is a frequently used manual pressure technique, is a pressure application that is applied with the thumb to the maximum tolerable pain point on the trigger points. With this application, the sense of pain signals reduce pain by inhibiting the sense of touch signals.
The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, ROM, PPT and functionality on patient with TMD. 42 patients were randomized into 2 groups : Group 2 (n:21) received only exercises (Rocabado's 6x6 exercises and posture exercises) as treatment, Group 1(n:21) received exercises (Rocabado's 6x6 exercises and posture exercises) and ischemic compression as treatment.The rest, activity and night pain in activity were assessed by visual analog scale, ROM assessed by a ruler and PPT assessed by a digital algometer at baseline (before treatment), after 1week treatment, after 2 week treatment and after 4 week treatment. Chronic pain severity were assessed by Graded Chronic Pain Scale version 2 and functionality were assessed by Jaw Function Limitation Scale-8 at baseline (before treatment) and after 4 week treatment. The efect size was calculated for the assessments used in the study.
- Conditions
- Temporomandibular Joint Dysfunction
- Being tested
- Ischemic compression, Exercises (Rocabodo's 6x6 exercises and posture exercises)
- Keywords
- temporomandibular joint, trigger points, myofascial pain syndrome
- 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.
Ischemic compressionOther
Ischemic compression was performed 3 times ; after the initial evaluation, after the first week evaulation and after the second week evaulations.
Exercises (Rocabodo's 6x6 exercises and posture exercises)Other
Rocabodo's 6x6 exercises exercise was shown to be administered for 4 weeks. After the first week evaluation, posture exercises are added to the exercise programs of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Exercises + ischemic compression group | Experimental | volunteer patients with temporomandibular joint dysfunction with trigger points Receives: Other: Ischemic compression; Other: Exercises (Rocabodo's 6x6 exercises and posture exercises) |
| Exercises group | Other | volunteer patients with temporomandibular joint dysfunction with trigger points Receives: Other: Exercises (Rocabodo's 6x6 exercises and posture exercises) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity and at night (on a 0-10 numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain). The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
Measured: The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
Secondary outcomes (4)
Graded Chronic Pain Scale version 2 (GCPS v2)
Chronic pain severity was assesed using the GCPS v2. Scores are calculated for 3 subscales: the characteristic pain intensity score, which ranges from 0-100, is calculated as the mean intensity ratings for reported current, worst, and average pain; the disability score, which ranges from 0-100, is calculated as the mean rating for difficulty performing daily, social, and work activities; and the disability points score, which ranges from 0-3, is derived from a combination of ranked categories of number of disability days and disability score. The 3 subscale scores are used to classify subjects into 1 of the 5 pain severity grades: grade 0 for no pain, grade I for low disability-low intensity, grade II for low disability-high intensity, grade III for high disability-moderately limiting, and grade IV for high disability-severely limiting. Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment.
Measured: Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment.
Jaw Range of Motions (ROM)
Jaw ROM measurements of unassisted painless mouth opening, maximum unassisted opening, maximum assisted opening, right lateral excursion and left lateral excursion were taken using a ruler. ROM were assessed by a ruler at before treatment, 1 week after start of treatment, 2 week after start of treatment and 4 week after start of treatment.
Measured: ROM were assessed by a ruler at before and after 1 week of treatment, before and after 2 week of treatment, before and after 4 week of treatment.
Jaw Functional Limitation Scale-8 (JFLS-8)
The functionality was assessed using JFLS-8. The JFLS-8 was developed as an 8-item global scale for overall functional limitation of the masticatory system. All items are evaluated between 0 and 10. (0: no restrictions, 10: maximum restrictions) JFLS-8 are calculated as the mean of the available items. The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment.
Measured: The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment.
Pain Pressure Threshold (PPT)
PPT was assessed using the digital algometer. Assessment was performed massater, temporalis, lateral of the temporomandibular joint, sternocleidomastoideus and trapezius. PPT was evaluated by a digital algometer at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
Measured: PPT was evaluated by a digital algometer at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start7 Jul 2019
- Primary completion7 Dec 2019
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Joint DysfunctionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Model description
- Individuals included in the study were randomized into two groups ; Group 1 : Exercises + ischemic compression Group 2 : Exercises Rocabado's 6x6 jaw exercises are shown to be applied to both groups for 4 weeks. After 1 week, posture exercises are added to the exercise programs of the patients. In addition to the exercises, Group 1 is given a total of 4 sessions of trigger point treatment after the initial evaluation, 1 week later, 2 weeks later and 4 weeks later.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa
- Investigators
- Olcay Şakar, Prof. Dr., Principal investigator, Istanbul UniversityHanifegül Taşkıran, Prof. Dr., Principal investigator, IstanbulAydın
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122352
- Sponsor's protocol ID
- 2019/81
- Status last verified
- Apr 2020
- First submitted
- 1 Oct 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaffer SM, Brismee JM, Sizer PS, Courtney CA. Temporomandibular disorders. Part 1: anatomy and examination/diagnosis. J Man Manip Ther. 2014 Feb;22(1):2-12. doi: 10.1179/2042618613Y.0000000060.
PubMed 24976743McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
PubMed 16649894Mulet M, Decker KL, Look JO, Lenton PA, Schiffman EL. A randomized clinical trial assessing the efficacy of adding 6 x 6 exercises to self-care for the treatment of masticatory myofascial pain. J Orofac Pain. 2007 Fall;21(4):318-28.
PubMed 18018993Cagnie B, Dewitte V, Coppieters I, Van Oosterwijck J, Cools A, Danneels L. Effect of ischemic compression on trigger points in the neck and shoulder muscles in office workers: a cohort study. J Manipulative Physiol Ther. 2013 Oct;36(8):482-9. doi: 10.1016/j.jmpt.2013.07.001. Epub 2013 Aug 28.
PubMed 23993756Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
PubMed 24482784Shaffer SM, Brismee JM, Sizer PS, Courtney CA. Temporomandibular disorders. Part 2: conservative management. J Man Manip Ther. 2014 Feb;22(1):13-23. doi: 10.1179/2042618613Y.0000000061.
PubMed 24976744
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Trigger Point Treatment on Pain and Functionality in Temporomandibular Joint Dysfunction
- ClinicalTrials.gov ID
- NCT04122352
- Acronym / sponsor ID
- 2019/81
- Conditions
- Temporomandibular Joint Dysfunction
- Keywords
- temporomandibular joint, trigger points, myofascial pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 7 Jul 2019 (actual)
- Primary completion
- 7 Dec 2019 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 10 Oct 2019 (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 aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, range of motion(ROM), pain pressure threshold (PPT) and functionality on patient with temporomandibular joint dysfunction.(TMD)
Detailed description
TMD is most common of pain and functional limitations of jaw. The ischemic compression and the exercises (Rocabado's 6x6 exercises and posture exercises) each relieve pain and increase funcitonality on TMD but which one has the more effect should be investigated.
The ROCABODO's 6x6 exercise program, which is a special for temporomandibular joint, includes repetitive movements that include patient education, patient self-care, lifestyle modifications, and recognizing which actions have the effect of increasing the symptoms of an individual's active participation. The repetitive movements relax the chewing muscles and reduce pain by helping the synovial fluid move along the joint surfaces, increasing circulation, removing joint nutrition, and removing the metabolites of articular cartilage.
Postural exercise is commonly used for pain/tension in neck or back, but can also be applied in the orofacial region, aiming to relief muscle symptoms such as pain, tension, stiffness, and tiredness ,by improving the position of the head or the mandibular. It is believed that wrong head position can cause muscle pain due to acceleration of muscle activity in the neck and jaw muscles, as well as postural reflex. Postural exercise includes head posture correction and myofascial release.
Ischemic compression, that is a frequently used manual pressure technique, is a pressure application that is applied with the thumb to the maximum tolerable pain point on the trigger points. With this application, the sense of pain signals reduce pain by inhibiting the sense of touch signals.
The aim of this study to investigate the effectiveness of trigger point treatments (ischemic compression) on pain intensity, chronic pain severity, ROM, PPT and functionality on patient with TMD. 42 patients were randomized into 2 groups : Group 2 (n:21) received only exercises (Rocabado's 6x6 exercises and posture exercises) as treatment, Group 1(n:21) received exercises (Rocabado's 6x6 exercises and posture exercises) and ischemic compression as treatment.The rest, activity and night pain in activity were assessed by visual analog scale, ROM assessed by a ruler and PPT assessed by a digital algometer at baseline (before treatment), after 1week treatment, after 2 week treatment and after 4 week treatment. Chronic pain severity were assessed by Graded Chronic Pain Scale version 2 and functionality were assessed by Jaw Function Limitation Scale-8 at baseline (before treatment) and after 4 week treatment. The efect size was calculated for the assessments used in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Individuals included in the study were randomized into two groups ; Group 1 : Exercises + ischemic compression Group 2 : Exercises Rocabado's 6x6 jaw exercises are shown to be applied to both groups for 4 weeks. After 1 week, posture exercises are added to the exercise programs of the patients. In addition to the exercises, Group 1 is given a total of 4 sessions of trigger point treatment after the initial evaluation, 1 week later, 2 weeks later and 4 weeks later.
| Arm | Type | Receives |
|---|---|---|
| Exercises + ischemic compression group | Experimental | Other: Ischemic compression, Other: Exercises (Rocabodo's 6x6 exercises and posture exercises)volunteer patients with temporomandibular joint dysfunction with trigger points |
| Exercises group | Other | Other: Exercises (Rocabodo's 6x6 exercises and posture exercises)volunteer patients with temporomandibular joint dysfunction with trigger points |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of TMD according to the criteria of DC / TMD (Diagnostic Criteria for Temporomandibular Disorders)
- Detection of trigger point during palpation of masticatory muscles
- Volunteer to participate in the study
Key exclusion criteria (6 listed)
- To have undergone TMJ or cervical surgery and have been treated from these regions in the last 3 months
- Presence of rheumatic disease including TMJ
- Patients with TMJ instability or fractures
- Cases with cognitive impairment
- Presence of chronic pain such as trigeminal neuralgia
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 |
|---|---|---|
| Ischemic compressionIschemic compression was performed 3 times ; after the initial evaluation, after the first week evaulation and after the second week evaulations. | Other | Exercises + ischemic compression group |
| Exercises (Rocabodo's 6x6 exercises and posture exercises)Rocabodo's 6x6 exercises exercise was shown to be administered for 4 weeks. After the first week evaluation, posture exercises are added to the exercise programs of the patients. | Other | Exercises + ischemic compression group, Exercises group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
Pain intensity was assessed using the VAS; each patient was asked the pain during the rest, activity and at night (on a 0-10 numerical pain rating scale with zero corresponding to no pain and 10 corresponding to terrible pain). The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
4 secondary outcomes
Graded Chronic Pain Scale version 2 (GCPS v2)
Time frame: Chronic pain severity was assessed by GCPS v2 at before and after 4 weeks of treatment.
Jaw Range of Motions (ROM)
Time frame: ROM were assessed by a ruler at before and after 1 week of treatment, before and after 2 week of treatment, before and after 4 week of treatment.
Jaw Functional Limitation Scale-8 (JFLS-8)
Time frame: The functionality was assessed by JFLS-8 at before and after 4 weeks of treatment.
Pain Pressure Threshold (PPT)
Time frame: PPT was evaluated by a digital algometer at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.
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 28 Apr 2020.
- Results publication: PubMed 24976743Shaffer SM, Brismee JM, Sizer PS, Courtney CA. Temporomandibular disorders. Part 1: anatomy and examination/diagnosis. J Man Manip Ther. 2014 Feb;22(1):2-12. doi: 10.1179/2042618613Y.0000000060.
- Results publication: PubMed 16649894McNeely ML, Armijo Olivo S, Magee DJ. A systematic review of the effectiveness of physical therapy interventions for temporomandibular disorders. Phys Ther. 2006 May;86(5):710-25.
- Results publication: PubMed 18018993Mulet M, Decker KL, Look JO, Lenton PA, Schiffman EL. A randomized clinical trial assessing the efficacy of adding 6 x 6 exercises to self-care for the treatment of masticatory myofascial pain. J Orofac Pain. 2007 Fall;21(4):318-28.
- Results publication: PubMed 23993756Cagnie B, Dewitte V, Coppieters I, Van Oosterwijck J, Cools A, Danneels L. Effect of ischemic compression on trigger points in the neck and shoulder muscles in office workers: a cohort study. J Manipulative Physiol Ther. 2013 Oct;36(8):482-9. doi: 10.1016/j.jmpt.2013.07.001. Epub 2013 Aug 28.
- Results publication: PubMed 24482784Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.
- Results publication: PubMed 24976744Shaffer SM, Brismee JM, Sizer PS, Courtney CA. Temporomandibular disorders. Part 2: conservative management. J Man Manip Ther. 2014 Feb;22(1):13-23. doi: 10.1179/2042618613Y.0000000061.
- 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.
Olcay Şakar, Prof. Dr. principal investigator
Istanbul University
Hanifegül Taşkıran, Prof. Dr. principal investigator
IstanbulAydın
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ischemic compression and Exercises (Rocabodo's 6x6 exercises and posture exercises) in people with Temporomandibular Joint Dysfunction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 6 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 28 Apr 2020. 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 Turkey (Türkiye). 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?
Visual Analog Scale (VAS) (time frame: The rest, activity and night pain in activity were assessed by VAS at before and after 1 week of treatment, before and after 2 weeks of treatment, before and after 4 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122352, which also lists 6 linked publications.
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 28 Apr 2020.