FybromyalgiaVIR-FMNCT07605143
Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia
A study testing Immersive Virtual Reality Exercise and convencional exercise in people with Fybromyalgia, run by gonzalo arias alvarez at 1 site in Chile.
Trial summary
Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive complaints, and psychoemotional symptoms, leading to functional impairment and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fybromyalgia
- What is being tested?
- Immersive Virtual Reality Exercise and convencional exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChile
- Study dates
- 15 Dec 2025to 26 Feb 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female participants aged 18 years or older
- Clinical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) diagnostic criteria
- Ability to understand and follow study procedures
- Provision of written informed consent
Who cannot join
- Pregnancy or breastfeeding
- Cancer-related pain
- Uncontrolled metabolic disorders
- History of vertigo, vestibular disorders, or any condition that could be aggravated by immersive virtual reality exposure
- Neurological or musculoskeletal conditions that contraindicated participation in therapeutic exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia: A Randomized Controlled Trial
Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive complaints, and psychoemotional symptoms, leading to functional impairment and reduced quality of life. Although exercise is recommended as a first-line non-pharmacological treatment, maintaining long-term adherence remains a major challenge.
Immersive virtual reality (IVR) has emerged as a promising approach to increase motivation and engagement during rehabilitation by integrating therapeutic exercise with interactive virtual environments. This randomized controlled trial evaluated the effects of a six-week exercise program delivered through immersive virtual reality compared with conventional exercise in women with fibromyalgia.
Participants were randomly assigned to either an IVR exercise group or a conventional exercise group. Clinical outcomes were assessed at baseline and after the intervention, including fibromyalgia-related impact, global cognitive screening performance, sleep quality, and psychoemotional symptoms. Treatment adherence and user experience were also evaluated to explore their association with clinical outcomes.
Read the detailed description
Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive dysfunction, and psychoemotional symptoms, resulting in substantial reductions in physical function and health-related quality of life. Although therapeutic exercise is considered a core component of fibromyalgia management, maintaining long-term adherence to exercise programs remains challenging due to pain exacerbation, fatigue, and reduced motivation.
Immersive virtual reality (IVR) has emerged as an innovative rehabilitation strategy that integrates therapeutic exercise with interactive virtual environments. By providing real-time visual feedback, immersive environments, and gamified exercise tasks, IVR may improve motivation, enjoyment, and engagement during rehabilitation while promoting adherence to structured exercise programs.
The present study was designed as a two-arm parallel-group randomized controlled trial comparing an immersive virtual reality exercise program with a conventional exercise program in women diagnosed with fibromyalgia according to the 2016 American College of Rheumatology diagnostic criteria. Participants were randomly allocated in a 1:1 ratio to either intervention and completed a supervised six-week rehabilitation program consisting of two sessions per week.
Participants allocated to the IVR group performed a combined intervention consisting of aerobic exercise followed by immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, Menlo Park, CA, USA) and the FitXR® platform (AeroBox modality). Participants allocated to the control group performed a conventional exercise program matched for treatment frequency and session duration. All intervention sessions were supervised by a physiotherapist trained in the study protocol.
Clinical assessments were performed at baseline and immediately after completion of the intervention. The predefined primary outcomes included fibromyalgia-related impact (FIQR), global cognitive screening performance (MoCA), psychoemotional symptoms (DASS-21), and sleep quality (Jenkins Sleep Questionnaire). Secondary outcomes included treatment adherence and user experience, assessed using the Player Experience of Need Satisfaction (PENS) questionnaire in participants allocated to the IVR group.
The primary objective of the randomized controlled trial was to compare the effects of immersive virtual reality exercise and conventional exercise on clinical outcomes in women with fibromyalgia. In addition, the study was designed to explore whether user experience during immersive virtual reality was associated with treatment adherence and changes in clinical outcomes.
- Conditions
- Fybromyalgia
- Being tested
- Immersive Virtual Reality Exercise, convencional exercise
- Keywords
- adherence, fibromialgia, virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immersive Virtual Reality ExerciseBehavioural
Also called Virtual Reality Training
Participants performed immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, USA) and the FitXR® platform (AeroBox modality). The intervention consisted of gamified boxing-based exercises requiring upper-limb movements, straight punches, hooks, uppercuts, lateral displacements, weight shifting, squatting, and obstacle avoidance within an immersive virtual environment. Participants received continuous real-time visual feedback while exercise difficulty progressed automatically according to individual performance. All sessions were supervised by a physical therapist.
convencional exerciseBehavioural
Participants performed a supervised conventional exercise program matched to the experimental intervention for treatment frequency, session duration, therapist supervision, and prescribed exercise intensity. The intervention included aerobic exercise followed by therapist-guided mobility, coordination, strengthening, balance, and functional movement exercises, concluding with stretching and breathing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Immersive Virtual Reality Exercise | Experimental | Participants performed immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, USA) and the FitXR® platform (AeroBox modality). The intervention consisted of gamified boxing-based exercises requiring upper-limb movements, straight punches, hooks, uppercuts, lateral displacements, weight shifting, squatting, and obstacle avoidance within an immersive virtual environment. Participants received continuous real-time visual feedback and automated performance reinforcement while exercise difficulty progressed according to individual performance. All sessions were supervised by a physical therapist. Receives: Behavioral: Immersive Virtual Reality Exercise |
| Conventional Exercise | Active comparator | Participants performed a supervised conventional exercise program matched to the experimental intervention for treatment frequency, session duration, therapist supervision, and overall exercise intensity. Sessions consisted of moderate-intensity aerobic exercise followed by a structured exercise circuit including boxing movements toward therapist-guided targets or a punching bag, squatting exercises, lateral trunk displacement tasks, and progressive coordination exercises, followed by cool-down stretching and breathing exercises. Receives: Behavioral: convencional exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact (FIQR Total Score)
Quality of life in patients with fibromyalgia will be assessed using the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), which evaluates the impact of fibromyalgia across three dimensions: difficulty in activities of daily living during the past week, overall impact of the disease during the past week, and symptom intensity during the past week.
The total score ranges from 0 to 100, with higher values indicating greater symptom severity and a higher level of functional disability
Measured: Baseline and immediately after completion of the 6-week intervention
Global Cognitive Function (MoCA Total Score)
Global cognitive function in both groups will be assessed using the MoCA questionnaire, a brief cognitive assessment tool that measures performance in domains such as memory, orientation, language, attention, executive function, and visuospatial abilities.
The MoCA total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A score of 26 or higher is generally considered within the normal cognitive range, although cutoff values may vary depending on age, education level, and clinical context.
Measured: Baseline and immediately after completion of the 6-week intervention
Depression, Anxiety, and Stress Symptoms (DASS-21)
Psychoemotional variables will be assessed using the DASS-21 questionnaire, which consists of 21 items designed to evaluate the presence of stress, anxiety, and/or depression. The instrument is divided into three subscales assessing depression, anxiety, and stress, with seven items assigned to each domain. Each item is rated on a 4-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"). Higher scores indicate greater severity of psychoemotional symptoms.
Measured: Baseline and immediately after completion of the 6-week intervention
Sleep Quality (Jenkins Sleep Questionnaire Score)
Sleep quality was assessed using the Jenkins Sleep Questionnaire, a validated instrument designed to measure the frequency of sleep-related difficulties during the previous week, including problems falling asleep, nighttime awakenings, non-restorative sleep, and fatigue upon waking. The questionnaire consists of four items rated according to the frequency of symptoms experienced, with higher scores indicating poorer sleep quality and greater sleep disturbance.
Measured: Baseline and immediately after completion of the 6-week intervention
Secondary outcomes (2)
User Experience (Player Experience of Need Satisfaction [PENS])
User experience will be assessed using the Player Experience of Need Satisfaction (PENS) questionnaire, which measures dimensions related to interactive virtual environments, including competence, autonomy, intuitive control, enjoyment, and presence/immersion. The questionnaire provides information on psychological need satisfaction during immersive virtual reality exercise. PENS will be administered only to participants allocated to the immersive virtual reality group immediately after completion of the intervention. Higher scores indicate a more positive user experience and greater satisfaction across the evaluated dimensions.
Measured: Immediately after completion of the 6-week intervention
Treatment Adherence (Percentage of Completed Sessions)
Adherence to the intervention program will be assessed as the percentage of completed sessions relative to the total number of scheduled sessions. Individual attendance at each session will be recorded to calculate treatment compliance. Adherence will be expressed as a percentage, with higher values indicating greater participation in the intervention program. This indicator will quantify participant engagement and will be used to explore its association with user experience and clinical outcomes.
Measured: Baseline and immediately after completion of the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Dec 2025
- Primary completion16 Feb 2026
- Study completion26 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FybromyalgiaStudies 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
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an immersive virtual reality exercise group or a conventional exercise group. Both groups completed a supervised six-week intervention consisting of two sessions per week. Clinical outcomes were assessed at baseline and immediately after completion of the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- gonzalo arias alvarez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, gonzalo arias alvarez, Universidad San Sebastián
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07605143
- Sponsor's protocol ID
- 202605RVI
- Other IDs
- 171-25
- Acronym
- VIR-FM
- Status last verified
- Jul 2026
- First submitted
- 13 May 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the informed consent approved by the institutional ethics committee did not include provisions for public data sharing. The dataset contains sensitive clinical information from participants with fibromyalgia, and confidentiality will be maintained in accordance with institutional ethical requirements and applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Immersive Virtual Reality-Based Rehabilitation on Quality of Life, Sleep Quality, and Cognitive Function in Women With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07605143
- Acronym / sponsor ID
- VIR-FM / 202605RVI
- Conditions
- Fybromyalgia
- Keywords
- adherence, fibromialgia, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- gonzalo arias alvarezUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 16 Feb 2026 (actual)
- Study completion
- 26 Feb 2026 (actual)
- First posted
- 22 May 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.
Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive complaints, and psychoemotional symptoms, leading to functional impairment and reduced quality of life. Although exercise is recommended as a first-line non-pharmacological treatment, maintaining long-term adherence remains a major challenge.
Immersive virtual reality (IVR) has emerged as a promising approach to increase motivation and engagement during rehabilitation by integrating therapeutic exercise with interactive virtual environments. This randomized controlled trial evaluated the effects of a six-week exercise program delivered through immersive virtual reality compared with conventional exercise in women with fibromyalgia.
Participants were randomly assigned to either an IVR exercise group or a conventional exercise group. Clinical outcomes were assessed at baseline and after the intervention, including fibromyalgia-related impact, global cognitive screening performance, sleep quality, and psychoemotional symptoms. Treatment adherence and user experience were also evaluated to explore their association with clinical outcomes.
Detailed description
Fibromyalgia is a chronic pain syndrome characterized by widespread musculoskeletal pain, fatigue, sleep disturbances, cognitive dysfunction, and psychoemotional symptoms, resulting in substantial reductions in physical function and health-related quality of life. Although therapeutic exercise is considered a core component of fibromyalgia management, maintaining long-term adherence to exercise programs remains challenging due to pain exacerbation, fatigue, and reduced motivation.
Immersive virtual reality (IVR) has emerged as an innovative rehabilitation strategy that integrates therapeutic exercise with interactive virtual environments. By providing real-time visual feedback, immersive environments, and gamified exercise tasks, IVR may improve motivation, enjoyment, and engagement during rehabilitation while promoting adherence to structured exercise programs.
The present study was designed as a two-arm parallel-group randomized controlled trial comparing an immersive virtual reality exercise program with a conventional exercise program in women diagnosed with fibromyalgia according to the 2016 American College of Rheumatology diagnostic criteria. Participants were randomly allocated in a 1:1 ratio to either intervention and completed a supervised six-week rehabilitation program consisting of two sessions per week.
Participants allocated to the IVR group performed a combined intervention consisting of aerobic exercise followed by immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, Menlo Park, CA, USA) and the FitXR® platform (AeroBox modality). Participants allocated to the control group performed a conventional exercise program matched for treatment frequency and session duration. All intervention sessions were supervised by a physiotherapist trained in the study protocol.
Clinical assessments were performed at baseline and immediately after completion of the intervention. The predefined primary outcomes included fibromyalgia-related impact (FIQR), global cognitive screening performance (MoCA), psychoemotional symptoms (DASS-21), and sleep quality (Jenkins Sleep Questionnaire). Secondary outcomes included treatment adherence and user experience, assessed using the Player Experience of Need Satisfaction (PENS) questionnaire in participants allocated to the IVR group.
The primary objective of the randomized controlled trial was to compare the effects of immersive virtual reality exercise and conventional exercise on clinical outcomes in women with fibromyalgia. In addition, the study was designed to explore whether user experience during immersive virtual reality was associated with treatment adherence and changes in clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to either an immersive virtual reality exercise group or a conventional exercise group. Both groups completed a supervised six-week intervention consisting of two sessions per week. Clinical outcomes were assessed at baseline and immediately after completion of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Immersive Virtual Reality Exercise | Experimental | Behavioral: Immersive Virtual Reality ExerciseParticipants performed immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, USA) and the FitXR® platform (AeroBox modality). The intervention consisted of gamified boxing-based exercises requiring upper-limb movements, straight punches, hooks, uppercuts, lateral displacements, weight shifting, squatting, and obstacle avoidance within an immersive virtual environment. Participants received continuous real-time visual feedback and automated performance reinforcement while exercise difficulty progressed according to individual performance. All sessions were supervised by a physical therapist. |
| Conventional Exercise | Active comparator | Behavioral: convencional exerciseParticipants performed a supervised conventional exercise program matched to the experimental intervention for treatment frequency, session duration, therapist supervision, and overall exercise intensity. Sessions consisted of moderate-intensity aerobic exercise followed by a structured exercise circuit including boxing movements toward therapist-guided targets or a punching bag, squatting exercises, lateral trunk displacement tasks, and progressive coordination exercises, followed by cool-down stretching and breathing exercises. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants aged 18 years or older
- Clinical diagnosis of fibromyalgia according to the 2016 American College of Rheumatology (ACR) diagnostic criteria
- Ability to understand and follow study procedures
- Provision of written informed consent
Key exclusion criteria (5 listed)
- Pregnancy or breastfeeding
- Cancer-related pain
- Uncontrolled metabolic disorders
- History of vertigo, vestibular disorders, or any condition that could be aggravated by immersive virtual reality exposure
- Neurological or musculoskeletal conditions that contraindicated participation in therapeutic exercise
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 |
|---|---|---|
| Immersive Virtual Reality ExerciseAlso: Virtual Reality TrainingParticipants performed immersive virtual reality exercise using Meta Quest 2 head-mounted displays (Meta Platforms, USA) and the FitXR® platform (AeroBox modality). The intervention consisted of gamified boxing-based exercises requiring upper-limb movements, straight punches, hooks, uppercuts, lateral displacements, weight shifting, squatting, and obstacle avoidance within an immersive virtual environment. Participants received continuous real-time visual feedback while exercise difficulty progressed automatically according to individual performance. All sessions were supervised by a physical therapist. | Behavioural | Immersive Virtual Reality Exercise |
| convencional exerciseParticipants performed a supervised conventional exercise program matched to the experimental intervention for treatment frequency, session duration, therapist supervision, and prescribed exercise intensity. The intervention included aerobic exercise followed by therapist-guided mobility, coordination, strengthening, balance, and functional movement exercises, concluding with stretching and breathing exercises. | Behavioural | Conventional Exercise |
Primary outcome
Fibromyalgia Impact (FIQR Total Score)
Time frame: Baseline and immediately after completion of the 6-week intervention
Quality of life in patients with fibromyalgia will be assessed using the Fibromyalgia Impact Questionnaire-Revised (FIQ-R), which evaluates the impact of fibromyalgia across three dimensions: difficulty in activities of daily living during the past week, overall impact of the disease during the past week, and symptom intensity during the past week. The total score ranges from 0 to 100, with higher values indicating greater symptom severity and a higher level of functional disability
Global Cognitive Function (MoCA Total Score)
Time frame: Baseline and immediately after completion of the 6-week intervention
Global cognitive function in both groups will be assessed using the MoCA questionnaire, a brief cognitive assessment tool that measures performance in domains such as memory, orientation, language, attention, executive function, and visuospatial abilities. The MoCA total score ranges from 0 to 30 points, with higher scores indicating better cognitive performance. A score of 26 or higher is generally considered within the normal cognitive range, although cutoff values may vary depending on age, education level, and clinical context.
Depression, Anxiety, and Stress Symptoms (DASS-21)
Time frame: Baseline and immediately after completion of the 6-week intervention
Psychoemotional variables will be assessed using the DASS-21 questionnaire, which consists of 21 items designed to evaluate the presence of stress, anxiety, and/or depression. The instrument is divided into three subscales assessing depression, anxiety, and stress, with seven items assigned to each domain. Each item is rated on a 4-point Likert scale ranging from 0 ("did not apply to me at all") to 3 ("applied to me very much or most of the time"). Higher scores indicate greater severity of psychoemotional symptoms.
Sleep Quality (Jenkins Sleep Questionnaire Score)
Time frame: Baseline and immediately after completion of the 6-week intervention
Sleep quality was assessed using the Jenkins Sleep Questionnaire, a validated instrument designed to measure the frequency of sleep-related difficulties during the previous week, including problems falling asleep, nighttime awakenings, non-restorative sleep, and fatigue upon waking. The questionnaire consists of four items rated according to the frequency of symptoms experienced, with higher scores indicating poorer sleep quality and greater sleep disturbance.
2 secondary outcomes
User Experience (Player Experience of Need Satisfaction [PENS])
Time frame: Immediately after completion of the 6-week intervention
Treatment Adherence (Percentage of Completed Sessions)
Time frame: Baseline and immediately after completion of the 6-week intervention
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 17 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the informed consent approved by the institutional ethics committee did not include provisions for public data sharing. The dataset contains sensitive clinical information from participants with fibromyalgia, and confidentiality will be maintained in accordance with institutional ethical requirements and applicable data protection regulations.
Related trials for Fybromyalgia
Enrolling by invitationObservational study
Assessment of Pain Experience in Fibromyalgia
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Interventional Study on the Effects of Forest Therapy in Fibromyalgia Patients
Fybromyalgia, Fibromyalgia (FM)
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 Immersive Virtual Reality Exercise and convencional exercise in people with Fybromyalgia, run by gonzalo arias alvarez at 1 site in Chile.
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 4 inclusion and 5 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 17 Jul 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 Chile. 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?
Fibromyalgia Impact (FIQR Total Score) (time frame: Baseline and immediately after completion of the 6-week intervention). The study lists 4 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 17 Jul 2026.