Shoulder TendinopathyNCT07550543
PEMF Therapy in Shoulder Tendinopathy
A study testing Nanopulsed Electromagnetic Field Therapy (SIS) and Balneophysiotherapy in people with Shoulder Tendinopathy, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
Trial summary
The goal of this clinical trial is to evaluate whether pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS), integrated into a multimodal rehabilitation program, improves pain, function, pressure pain threshold, muscle strength, psychological status, and quality of life in adults… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Tendinopathy
- What is being tested?
- Nanopulsed Electromagnetic Field Therapy (SIS) and Balneophysiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2026to 25 Aug 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged between 18 and 70 years.
- Patients with chronic shoulder pain lasting more than 3 months, of non-traumatic origin, persistent despite prior conservative treatment.
- Clinical diagnosis of shoulder tendinopathy and/or subacromial pain syndrome based on medical history and physical examination.
- Presence of shoulder pain and functional limitation confirmed by clinical assessment and baseline functional evaluation (SPADI).
- Ability to comply with the treatment protocol and attend scheduled follow-up assessments.
- Provision of written informed consent prior to participation.
Who cannot join
- Full-thickness rotator cuff tears with surgical indication.
- Recent major shoulder trauma (within the last 6 months).
- Active systemic inflammatory or rheumatologic diseases.
- Presence of metallic implants in the treatment area or implanted electronic devices (e.g., pacemaker).
- Neurological disorders affecting the upper limb.
- Contraindications to balneotherapy (e.g., severe cardiovascular disease, renal failure, severe dermatological conditions).
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- Decompensated chronic diseases at the time of enrollment (cardiovascular, hepatic, renal, respiratory, or neurological).
- Skin lesions at the site of treatment application.
- Pregnancy or breastfeeding.
- Active neoplastic disease.
- Decompensated psychiatric disorders.
- History of hypersensitivity to natural therapeutic factors used in balneotherapy.
- Refusal to participate or inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Romania1 site
Balneal and Rehabilitation Sanatorium of Techirghiol
Constanța, Techirghiol, 906100
About this study
Official title: Effect of Pulsed Electromagnetic Field (PEMF) Therapy Delivered Via the Super Inductive System (SIS) Combined With Balneophysiotherapy in Patients With Shoulder Tendinopathies: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS), integrated into a multimodal rehabilitation program, improves pain, function, pressure pain threshold, muscle strength, psychological status, and quality of life in adults with shoulder tendinopathies.
The main questions it aims to answer are:
Read more
- Does the addition of PEMF (SIS) therapy reduce pain intensity and improve pressure pain threshold compared to standard balneophysiotherapy?
- Does PEMF (SIS) therapy improve shoulder function, muscle strength, psychological status, and quality of life? The study compares a multimodal rehabilitation program supplemented with PEMF (SIS) therapy to standard balneophysiotherapy to determine whether the addition of PEMF (SIS) provides superior clinical outcomes.
Participants will:
- Undergo a multimodal rehabilitation program including balneophysiotherapy
- Be assigned to receive either standard treatment or treatment supplemented with PEMF (SIS) therapy
- Be assessed at three time points: T0 (baseline, at admission), T1 (immediately after completion of the 10-day treatment program), and T2 (3 months after treatment completion), using validated clinical instruments assessing pain, function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life.
Read the detailed description
Shoulder tendinopathies are a common cause of pain, functional limitation, and reduced quality of life, with a significant impact on daily activities. Their clinical presentation is heterogeneous, involving not only structural and functional impairments but also activity limitations and participation restrictions.
Conservative management remains the first-line approach and typically includes multimodal rehabilitation programs incorporating balneophysiotherapy, exercise therapy, and physical modalities. Although these interventions are widely used and have demonstrated clinical benefits, the optimal combination of therapeutic modalities remains a subject of ongoing research.
Pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS) is a non-invasive intervention with potential analgesic, neuromodulatory, and regenerative effects. However, evidence regarding its additional benefit when integrated into standard multimodal rehabilitation programs for shoulder tendinopathies is still limited.
Given the multifactorial nature of shoulder tendinopathies, a multidimensional assessment approach is required. This study is based on the framework of the International Classification of Functioning, Disability and Health (ICF) and aligned with OMERACT recommendations, allowing a comprehensive evaluation of clinical outcomes across multiple domains.
The aim of this study is to compare the effectiveness of PEMF therapy delivered via SIS, integrated into a multimodal rehabilitation program, with standard balneophysiotherapy in patients with shoulder tendinopathies.
Participants are allocated to either a control group receiving standard treatment or an experimental group receiving the same rehabilitation program supplemented with PEMF (SIS) therapy. Clinical outcomes, including pain intensity, shoulder function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life, are assessed at three time points: T0 (baseline, at admission), T1 (immediately after completion of the 10-day treatment program), and T2 (3 months after treatment completion). The follow-up assessment aims to evaluate the maintenance of therapeutic effects over time.
This study seeks to determine whether the addition of PEMF (SIS) therapy provides superior outcomes within a multimodal rehabilitation strategy and supports a personalized, multidimensional approach to the management of shoulder tendinopathies.
- Conditions
- Shoulder Tendinopathy
- Being tested
- Nanopulsed Electromagnetic Field Therapy (SIS), Balneophysiotherapy
- Keywords
- Nanopulsed Electromagnetic Field, Pulsed Electromagnetic Field, PEMF, Super Inductive System, Balneotherapy, Physiotherapy, Shoulder Pain, Tendinopathy
- Medical subject headings
- Shoulder Pain, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanopulsed Electromagnetic Field Therapy (SIS)Device
Nanopulsed electromagnetic field therapy is delivered using the Super Inductive System (SIS) device applied to the affected shoulder. The intervention is administered daily over a two-week period, with a total of 10 sessions. Each session lasts approximately 10-15 minutes. The therapy delivers high-intensity electromagnetic pulses with adjustable frequency and intensity, aiming to reduce pain, stimulate tissue regeneration, and improve functional outcomes.
BalneophysiotherapyOther
The intervention is based on the region's specific natural therapeutic resources and is conducted under continuous medical supervision. The treatment program includes saline therapeutic baths combined with exercise therapy and applications of sapropelic therapeutic mud, administered daily over a two-week period, five days per week. In addition, patients receive electrotherapy according to a standardized protocol, including magnetotherapy, interferential current therapy, and therapeutic ultrasound. The rehabilitation program also incorporates massage therapy and individualized therapeutic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group | Experimental | Participants in the experimental group receive a standardized balneophysiotherapy program combined with nanopulsed electromagnetic field therapy (Super Inductive System) applied to the affected shoulder, delivered over 10 treatment days at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. Receives: Device: Nanopulsed Electromagnetic Field Therapy (SIS) |
| Balneophysiotherapy Control Group | Active comparator | Participants allocated to the control group receive a structured two-week rehabilitation program comprising balneophysiotherapy interventions at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. Receives: Other: Balneophysiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity assessed by Visual Analog Scale (VAS)
Pain intensity will be measured using the Visual Analog Scale (VAS). Participants were asked to rate their current pain intensity by marking a point on a 100-mm horizontal line, where 0 indicates "no pain" and 100 indicates "worst pain imaginable." The score was recorded in millimeters (mm). Outcome range and interpretation: Minimum value: 0; Maximum value: 100. Higher scores indicate worse pain intensity.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Secondary outcomes (7)
Shoulder function assessed by Shoulder Pain and Disability Index (SPADI)
Shoulder pain and disability were assessed using the Shoulder Pain and Disability Index (SPADI), a self-administered questionnaire consisting of two domains: pain (5 items) and disability (8 items). Each item is scored on a scale from 0 to 10, with higher scores indicating greater pain and functional impairment. The total SPADI score is expressed as a percentage (0-100%).
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Pressure Pain Threshold (PPT) assessed by digital algometry
Pressure pain threshold will be measured using a digital algometer at standardized anatomical points of the shoulder. The mean value of repeated measurements will be recorded.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Range of motion (ROM) assessed by goniometry
Active range of motion of the shoulder (flexion, abduction, external rotation, internal rotation) will be measured using a goniometer.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Muscle strength assessed by dynamometry
Shoulder muscle strength was assessed using a handheld dynamometer. Measurements were performed for key shoulder movements, and values were recorded in kilograms. Higher values indicate greater muscle strength.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Psychological status assessed by Hospital Anxiety and Depression Scale (HADS)
Psychological status was assessed using the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items divided into two subscales: anxiety (HADS-A) and depression (HADS-D), each containing 7 items. Participants rated how they had been feeling over the previous week. Each item is scored on a 4-point Likert scale ranging from 0 to 3. Subscale scores were calculated by summing the relevant item scores and are reported as unitless values. Outcome range and interpretation: HADS-A (Anxiety): Minimum value: 0; Maximum value: 21. Higher scores indicate greater anxiety severity. HADS-D (Depression): Minimum value: 0; Maximum value: 21. Higher scores indicate greater depressive symptom severity.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Depression severity assessed by Patient Health Questionnaire-9 (PHQ-9)
Depression severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a self-administered questionnaire consisting of 9 items scored from 0 to 3. Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Quality of life assessed by EQ-5D-5L
Quality of life was assessed using the EQ-5D-5L questionnaire, which evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels of severity. Higher scores indicate poorer quality of life.
Measured: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Apr 2026
- Primary completion25 Aug 2026
- Study completion25 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder TendinopathyStudies 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
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balnear and Rehabilitation Sanatorium Techirghiol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena-Valentina Ionescu, Balnear and Rehabilitation Sanatorium Techirghiol
- Investigators
- Alexandra-Ecaterina Ciota, MD, Principal investigator, Balneal and Rehabilitation Sanatorium Techirghiol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550543
- Sponsor's protocol ID
- AlexandraCiota
- Status last verified
- Oct 2026
- First submitted
- 16 Apr 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsed Electromagnetic Field (PEMF) Therapy Delivered Via the Super Inductive System (SIS) Combined With Balneophysiotherapy in Patients With Shoulder Tendinopathies: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07550543
- Acronym / sponsor ID
- AlexandraCiota
- Conditions
- Shoulder Tendinopathy
- Keywords
- Nanopulsed Electromagnetic Field, Pulsed Electromagnetic Field, PEMF, Super Inductive System, Balneotherapy, Physiotherapy, Shoulder Pain, Tendinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Balnear and Rehabilitation Sanatorium TechirghiolUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 25 Aug 2026 (actual)
- Study completion
- 25 Aug 2026 (actual)
- First posted
- 24 Apr 2026 (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 goal of this clinical trial is to evaluate whether pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS), integrated into a multimodal rehabilitation program, improves pain, function, pressure pain threshold, muscle strength, psychological status, and quality of life in adults with shoulder tendinopathies.
The main questions it aims to answer are:
- Does the addition of PEMF (SIS) therapy reduce pain intensity and improve pressure pain threshold compared to standard balneophysiotherapy?
- Does PEMF (SIS) therapy improve shoulder function, muscle strength, psychological status, and quality of life? The study compares a multimodal rehabilitation program supplemented with PEMF (SIS) therapy to standard balneophysiotherapy to determine whether the addition of PEMF (SIS) provides superior clinical outcomes.
Participants will:
- Undergo a multimodal rehabilitation program including balneophysiotherapy
- Be assigned to receive either standard treatment or treatment supplemented with PEMF (SIS) therapy
- Be assessed at three time points: T0 (baseline, at admission), T1 (immediately after completion of the 10-day treatment program), and T2 (3 months after treatment completion), using validated clinical instruments assessing pain, function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life.
Detailed description
Shoulder tendinopathies are a common cause of pain, functional limitation, and reduced quality of life, with a significant impact on daily activities. Their clinical presentation is heterogeneous, involving not only structural and functional impairments but also activity limitations and participation restrictions.
Conservative management remains the first-line approach and typically includes multimodal rehabilitation programs incorporating balneophysiotherapy, exercise therapy, and physical modalities. Although these interventions are widely used and have demonstrated clinical benefits, the optimal combination of therapeutic modalities remains a subject of ongoing research.
Pulsed electromagnetic field (PEMF) therapy delivered via the Super Inductive System (SIS) is a non-invasive intervention with potential analgesic, neuromodulatory, and regenerative effects. However, evidence regarding its additional benefit when integrated into standard multimodal rehabilitation programs for shoulder tendinopathies is still limited.
Given the multifactorial nature of shoulder tendinopathies, a multidimensional assessment approach is required. This study is based on the framework of the International Classification of Functioning, Disability and Health (ICF) and aligned with OMERACT recommendations, allowing a comprehensive evaluation of clinical outcomes across multiple domains.
The aim of this study is to compare the effectiveness of PEMF therapy delivered via SIS, integrated into a multimodal rehabilitation program, with standard balneophysiotherapy in patients with shoulder tendinopathies.
Participants are allocated to either a control group receiving standard treatment or an experimental group receiving the same rehabilitation program supplemented with PEMF (SIS) therapy. Clinical outcomes, including pain intensity, shoulder function, pressure pain threshold, muscle strength, psychological status, depressive symptoms, and quality of life, are assessed at three time points: T0 (baseline, at admission), T1 (immediately after completion of the 10-day treatment program), and T2 (3 months after treatment completion). The follow-up assessment aims to evaluate the maintenance of therapeutic effects over time.
This study seeks to determine whether the addition of PEMF (SIS) therapy provides superior outcomes within a multimodal rehabilitation strategy and supports a personalized, multidimensional approach to the management of shoulder tendinopathies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group | Experimental | Device: Nanopulsed Electromagnetic Field Therapy (SIS)Participants in the experimental group receive a standardized balneophysiotherapy program combined with nanopulsed electromagnetic field therapy (Super Inductive System) applied to the affected shoulder, delivered over 10 treatment days at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. |
| Balneophysiotherapy Control Group | Active comparator | Other: BalneophysiotherapyParticipants allocated to the control group receive a structured two-week rehabilitation program comprising balneophysiotherapy interventions at the Balneal and Rehabilitation Sanatorium Techirghiol, Romania. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged between 18 and 70 years.
- Patients with chronic shoulder pain lasting more than 3 months, of non-traumatic origin, persistent despite prior conservative treatment.
- Clinical diagnosis of shoulder tendinopathy and/or subacromial pain syndrome based on medical history and physical examination.
- Presence of shoulder pain and functional limitation confirmed by clinical assessment and baseline functional evaluation (SPADI).
- Ability to comply with the treatment protocol and attend scheduled follow-up assessments.
Key exclusion criteria (13 listed)
- Full-thickness rotator cuff tears with surgical indication.
- Recent major shoulder trauma (within the last 6 months).
- Active systemic inflammatory or rheumatologic diseases.
- Presence of metallic implants in the treatment area or implanted electronic devices (e.g., pacemaker).
- Neurological disorders affecting the upper limb.
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 |
|---|---|---|
| Nanopulsed Electromagnetic Field Therapy (SIS)Nanopulsed electromagnetic field therapy is delivered using the Super Inductive System (SIS) device applied to the affected shoulder. The intervention is administered daily over a two-week period, with a total of 10 sessions. Each session lasts approximately 10-15 minutes. The therapy delivers high-intensity electromagnetic pulses with adjustable frequency and intensity, aiming to reduce pain, stimulate tissue regeneration, and improve functional outcomes. | Device | Balneophysiotherapy plus Nanopulsed Electromagnetic Field Therapy Group |
| BalneophysiotherapyThe intervention is based on the region's specific natural therapeutic resources and is conducted under continuous medical supervision. The treatment program includes saline therapeutic baths combined with exercise therapy and applications of sapropelic therapeutic mud, administered daily over a two-week period, five days per week. In addition, patients receive electrotherapy according to a standardized protocol, including magnetotherapy, interferential current therapy, and therapeutic ultrasound. The rehabilitation program also incorporates massage therapy and individualized therapeutic exercises. | Other | Balneophysiotherapy Control Group |
Primary outcome
Pain intensity assessed by Visual Analog Scale (VAS)
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Pain intensity will be measured using the Visual Analog Scale (VAS). Participants were asked to rate their current pain intensity by marking a point on a 100-mm horizontal line, where 0 indicates "no pain" and 100 indicates "worst pain imaginable." The score was recorded in millimeters (mm). Outcome range and interpretation: Minimum value: 0; Maximum value: 100. Higher scores indicate worse pain intensity.
7 secondary outcomes
Shoulder function assessed by Shoulder Pain and Disability Index (SPADI)
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Pressure Pain Threshold (PPT) assessed by digital algometry
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Range of motion (ROM) assessed by goniometry
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Muscle strength assessed by dynamometry
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Psychological status assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Depression severity assessed by Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
Quality of life assessed by EQ-5D-5L
Time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).
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 21 Oct 2026.
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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.
Alexandra-Ecaterina Ciota, MD principal investigator
Balneal and Rehabilitation Sanatorium Techirghiol
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nanopulsed Electromagnetic Field Therapy (SIS) and Balneophysiotherapy in people with Shoulder Tendinopathy, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
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 6 inclusion and 13 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 21 Oct 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 Romania. 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?
Pain intensity assessed by Visual Analog Scale (VAS) (time frame: Baseline (T0), immediately after the 10-day treatment period (T1), and 3 months after treatment completion (T2).). 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 21 Oct 2026.