Shoulder InjuriesNCT06026137
Use of the Efisiotrack System for Monitoring Patients With Shoulder Orthopedic Injuries
A study testing eFisioTrack Group and Excercises Group in people with Shoulder Injuries, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.
Trial summary
To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Injuries
- What is being tested?
- eFisioTrack Group and Excercises Group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jun 2023to 30 Sep 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
- Be at least 18 years old and be able to read and understand Spanish.
- Suffer a traumatic or degenerative shoulder injury, with or without surgical treatment.
- Have a prescription for rehabilitative physical therapy that includes active exercises.
Who cannot join
- -Had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital General of Elche
Elche, Alicante, 03203
Jorge Roses Conde, Ph, 966 61 69 00 ext. 6900, jroses@umh.es
About this study
Official title: Use of the Efisiotrack System for Monitoring Prescribed Therapeutic Exercises in Patients With Shoulder Orthopedic Injuries in a Hospital Setting: a Pilot Feasibility Study
To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.
Read the detailed description
Patients who be referred to the rehabilitation service of the University Hospital of Elche (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study.
Patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception).
Following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. These will be performed independently by each patient in a hospital room without supervision by the physiotherapist.
The following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the Constant-Murley (CM) score.
All participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.
- Conditions
- Shoulder Injuries
- Being tested
- eFisioTrack Group, Excercises Group
- Keywords
- rehabilitation, shoulder injury, monitoring device, adherence
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eFisioTrack GroupProcedure or surgery
Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity using the efisioTrack system without supervision by the physiotherapist.
Excercises GroupProcedure or surgery
Application of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity supervised by the physical physiotherapist in a hospital room.
| Study group | Role | What they receive |
|---|---|---|
| eFisioTrack Group | Experimental | Use of the eFisioTrack platform in the experimental group to perform active exercises as part of their shoulder rehabilitation. These will. bee performed independently by each patient in a hospital room, using the efisioTrack system without supervision by the physiotherapist.
The subjects will be previously instructed in the use of the system in two 20-minute sessions. The type of exercise and its parameters will be chosen and progressed considering the functional status of the patient and being similar to those executed under the physiotherapist's supervision. Receives: Procedure: eFisioTrack Group |
| Excercises Group | Active comparator | Patients who performed the exercise program supervised by the physical physiotherapist in a hospital room. Receives: Procedure: Excercises Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disabilities of Arm, Shoulder and Hand (DASH) score
DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.
Measured: At baseline and at one month follow-up.
Secondary outcomes (1)
Constant-Murley (CM) score.
CMS - specific instrument for assessing the shoulder joint: pain; ability to perform daily activities; mobility and strength. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: At baseline and at one month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start29 Jun 2023
- Primary completion30 Aug 2023
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies 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
- Investigator, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Miguel Hernandez de Elche
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital General Universitario Elche
- Responsible party
- Principal investigator, JOSE VICENTE TOLEDO MARHUENDA, Universidad Miguel Hernandez de Elche
- Investigators
- Jorge Roses Conde, Ph, Study director, Hospital Generalof Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026137
- Sponsor's protocol ID
- JVT002
- Status last verified
- Sep 2023
- First submitted
- 18 Jul 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
PubMed 22349588Baroni MP, Jacob MFA, Rios WR, Fandim JV, Fernandes LG, Chaves PI, Fioratti I, Saragiotto BT. The state of the art in telerehabilitation for musculoskeletal conditions. Arch Physiother. 2023 Jan 4;13(1):1. doi: 10.1186/s40945-022-00155-0.
PubMed 36597130Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.
PubMed 30441330Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.
PubMed 17040628Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022 Dec 8;23(1):1073. doi: 10.1186/s12891-022-05973-8.
PubMed 36476476Greenberg DL. Evaluation and treatment of shoulder pain. Med Clin North Am. 2014 May;98(3):487-504. doi: 10.1016/j.mcna.2014.01.016. Epub 2014 Mar 22.
PubMed 24758957Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
PubMed 27283590Kromer TO, Tautenhahn UG, de Bie RA, Staal JB, Bastiaenen CH. Effects of physiotherapy in patients with shoulder impingement syndrome: a systematic review of the literature. J Rehabil Med. 2009 Nov;41(11):870-80. doi: 10.2340/16501977-0453.
PubMed 19841837Babatunde OO, Ensor J, Littlewood C, Chesterton L, Jordan JL, Corp N, Wynne-Jones G, Roddy E, Foster NE, van der Windt DA. Comparative effectiveness of treatment options for subacromial shoulder conditions: a systematic review and network meta-analysis. Ther Adv Musculoskelet Dis. 2021 Sep 9;13:1759720X211037530. doi: 10.1177/1759720X211037530. eCollection 2021.
PubMed 34527083Paraskevopoulos E, Plakoutsis G, Chronopoulos E, Maria P. Effectiveness of Combined Program of Manual Therapy and Exercise Vs Exercise Only in Patients With Rotator Cuff-related Shoulder Pain: A Systematic Review and Meta-analysis. Sports Health. 2023 Sep-Oct;15(5):727-735. doi: 10.1177/19417381221136104. Epub 2022 Dec 14.
PubMed 36517977Burns D, Boyer P, Razmjou H, Richards R, Whyne C. Adherence Patterns and Dose Response of Physiotherapy for Rotator Cuff Pathology: Longitudinal Cohort Study. JMIR Rehabil Assist Technol. 2021 Mar 11;8(1):e21374. doi: 10.2196/21374.
PubMed 33704076Eriksson L, Lindstrom B, Ekenberg L. Patients' experiences of telerehabilitation at home after shoulder joint replacement. J Telemed Telecare. 2011;17(1):25-30. doi: 10.1258/jtt.2010.100317. Epub 2010 Nov 12.
PubMed 21075802Carnevale A, Longo UG, Schena E, Massaroni C, Lo Presti D, Berton A, Candela V, Denaro V. Wearable systems for shoulder kinematics assessment: a systematic review. BMC Musculoskelet Disord. 2019 Nov 15;20(1):546. doi: 10.1186/s12891-019-2930-4.
PubMed 31731893Sliepen M, Lipperts M, Tjur M, Mechlenburg I. Use of accelerometer-based activity monitoring in orthopaedics: benefits, impact and practical considerations. EFORT Open Rev. 2020 Jan 28;4(12):678-685. doi: 10.1302/2058-5241.4.180041. eCollection 2019 Dec.
PubMed 32010456Rizzo JR, Thai P, Li EJ, Tung T, Hudson TE, Herrera J, Raghavan P. Structured Wii protocol for rehabilitation of shoulder impingement syndrome: A pilot study. Ann Phys Rehabil Med. 2017 Nov;60(6):363-370. doi: 10.1016/j.rehab.2016.10.004. Epub 2017 Mar 15.
PubMed 28330586
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Efisiotrack System for Monitoring Prescribed Therapeutic Exercises in Patients With Shoulder Orthopedic Injuries in a Hospital Setting: a Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06026137
- Acronym / sponsor ID
- JVT002
- Conditions
- Shoulder Injuries
- Keywords
- rehabilitation, shoulder injury, monitoring device, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidad Miguel Hernandez de ElcheUniversity, hospital or other
- Collaborators
- Hospital General Universitario Elche
- Study start
- 29 Jun 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 6 Sep 2023 (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.
To evaluate the effect on clinical variables of monitoring exercises prescribed for shoulder injury rehabilitation with the eFisioTrack platform in patients of the Rehabilitation Service at University Hospital of Elche.
Detailed description
Patients who be referred to the rehabilitation service of the University Hospital of Elche (Spain) for physiotherapy treatment (manual therapy, exercise, stretching, and electrotherapy) after suffering orthopedic injury or surgery in the shoulder joint complex will be considered for enrollment in the study.
Patients will performed the prescribed physical therapy treatment, at least three times per week in sessions of 45 minutes in the hospital setting (application of manual therapy and physical modalities as ultrasound, heat/cold, laser, magnetic field therapy) together with completion of the exercise program for functional recovery of the upper extremity (exercises for muscle strength, scapular stability, joint mobility, and proprioception).
Following baseline examination, patients will be randomly assigned to either physiotherapist-supervised exercise (control group) or monitoring by the eFisioTrack system (experimental group) to perform active exercises as part of their shoulder rehabilitation. These will be performed independently by each patient in a hospital room without supervision by the physiotherapist.
The following patient-reported outcome measures will be used to assess participants' shoulder pain and function: the Disabilities of Arm, Shoulder and Hand (DASH) score and the Constant-Murley (CM) score.
All participants will be assessed at baseline on their first visit to the physical therapy area and at one-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eFisioTrack Group | Experimental | Procedure: eFisioTrack GroupUse of the eFisioTrack platform in the experimental group to perform active exercises as part of their shoulder rehabilitation. These will. bee performed independently by each patient in a hospital room, using the efisioTrack system without supervision by the physiotherapist. The subjects will be previously instructed in the use of the system in two 20-minute sessions. The type of exercise and its parameters will be chosen and progressed considering the functional status of the patient and being similar to those executed under the physiotherapist's supervision. |
| Excercises Group | Active comparator | Procedure: Excercises GroupPatients who performed the exercise program supervised by the physical physiotherapist in a hospital room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years old and be able to read and understand Spanish.
- Suffer a traumatic or degenerative shoulder injury, with or without surgical treatment.
- Have a prescription for rehabilitative physical therapy that includes active exercises.
Key exclusion criteria (1 listed)
- -Had a concomitant injury on an upper extremity or the cervical spine at the time of participation or sequelae of previous injuries in the area.
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 |
|---|---|---|
| eFisioTrack GroupApplication of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity using the efisioTrack system without supervision by the physiotherapist. | Procedure or surgery | eFisioTrack Group |
| Excercises GroupApplication of manual therapy and physical modalities together with completion of the exercise program for functional recovery of the upper extremity supervised by the physical physiotherapist in a hospital room. | Procedure or surgery | Excercises Group |
Primary outcome
Disabilities of Arm, Shoulder and Hand (DASH) score
Time frame: At baseline and at one month follow-up.
DASH - Measures symptoms and degree of function related to a disorder in the upper extremity. The DASH Outcome Measure is scored in two components: the disability/symptom section (30 items, scored 1-5) and the optional high performance Sport/Music or Work section (4 items, scored 1-5). At least 27 of the 30 items must be completed for a score to be calculated. The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.
1 secondary outcome
Constant-Murley (CM) score.
Time frame: At baseline and at one month follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 22349588Holmgren T, Bjornsson Hallgren H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise strategy on need for surgery in patients with subacromial impingement syndrome: randomised controlled study. BMJ. 2012 Feb 20;344:e787. doi: 10.1136/bmj.e787.
- Background: PubMed 36597130Baroni MP, Jacob MFA, Rios WR, Fandim JV, Fernandes LG, Chaves PI, Fioratti I, Saragiotto BT. The state of the art in telerehabilitation for musculoskeletal conditions. Arch Physiother. 2023 Jan 4;13(1):1. doi: 10.1186/s40945-022-00155-0.
- Background: PubMed 30441330Carbonaro N, Lucchesi I, Lorusssi F, Tognetti A. Tele-monitoring and tele-rehabilitation of the shoulder muscular-skeletal diseases through wearable systems. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:4410-4413. doi: 10.1109/EMBC.2018.8513371.
- Background: PubMed 17040628Hervas MT, Navarro Collado MJ, Peiro S, Rodrigo Perez JL, Lopez Mateu P, Martinez Tello I. [Spanish version of the DASH questionnaire. Cross-cultural adaptation, reliability, validity and responsiveness]. Med Clin (Barc). 2006 Sep 30;127(12):441-7. doi: 10.1157/13093053. Spanish.
- Results publication: PubMed 36476476Lucas J, van Doorn P, Hegedus E, Lewis J, van der Windt D. A systematic review of the global prevalence and incidence of shoulder pain. BMC Musculoskelet Disord. 2022 Dec 8;23(1):1073. doi: 10.1186/s12891-022-05973-8.
- Results publication: PubMed 24758957Greenberg DL. Evaluation and treatment of shoulder pain. Med Clin North Am. 2014 May;98(3):487-504. doi: 10.1016/j.mcna.2014.01.016. Epub 2014 Mar 22.
- Results publication: PubMed 27283590Page MJ, Green S, McBain B, Surace SJ, Deitch J, Lyttle N, Mrocki MA, Buchbinder R. Manual therapy and exercise for rotator cuff disease. Cochrane Database Syst Rev. 2016 Jun 10;2016(6):CD012224. doi: 10.1002/14651858.CD012224.
- Results publication: PubMed 19841837Kromer TO, Tautenhahn UG, de Bie RA, Staal JB, Bastiaenen CH. Effects of physiotherapy in patients with shoulder impingement syndrome: a systematic review of the literature. J Rehabil Med. 2009 Nov;41(11):870-80. doi: 10.2340/16501977-0453.
- Results publication: PubMed 34527083Babatunde OO, Ensor J, Littlewood C, Chesterton L, Jordan JL, Corp N, Wynne-Jones G, Roddy E, Foster NE, van der Windt DA. Comparative effectiveness of treatment options for subacromial shoulder conditions: a systematic review and network meta-analysis. Ther Adv Musculoskelet Dis. 2021 Sep 9;13:1759720X211037530. doi: 10.1177/1759720X211037530. eCollection 2021.
- Results publication: PubMed 36517977Paraskevopoulos E, Plakoutsis G, Chronopoulos E, Maria P. Effectiveness of Combined Program of Manual Therapy and Exercise Vs Exercise Only in Patients With Rotator Cuff-related Shoulder Pain: A Systematic Review and Meta-analysis. Sports Health. 2023 Sep-Oct;15(5):727-735. doi: 10.1177/19417381221136104. Epub 2022 Dec 14.
- Results publication: PubMed 33704076Burns D, Boyer P, Razmjou H, Richards R, Whyne C. Adherence Patterns and Dose Response of Physiotherapy for Rotator Cuff Pathology: Longitudinal Cohort Study. JMIR Rehabil Assist Technol. 2021 Mar 11;8(1):e21374. doi: 10.2196/21374.
- Results publication: PubMed 21075802Eriksson L, Lindstrom B, Ekenberg L. Patients' experiences of telerehabilitation at home after shoulder joint replacement. J Telemed Telecare. 2011;17(1):25-30. doi: 10.1258/jtt.2010.100317. Epub 2010 Nov 12.
- Individual participant dataSharing planned: No
Related trials for Shoulder Injuries
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
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.
Jorge Roses Conde, Ph study director
Hospital Generalof Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eFisioTrack Group and Excercises Group in people with Shoulder Injuries, run by Universidad Miguel Hernandez de Elche 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 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: status not confirmed, as of the sponsor's last update on 6 Sep 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 Jose-Vicente Toledo-Marhuenda, PhD. (965 91 92 60 ext. 9260, josetoledo@umh.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disabilities of Arm, Shoulder and Hand (DASH) score (time frame: At baseline and at one month follow-up.). 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 NCT06026137, which also lists 26 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 6 Sep 2023.