FibromyalgiaNCT04108702
Virtual Reality as a New Therapeutic Tool for Chronic Pain
A study testing Virtual reality heart and Standard therapy in people with Fibromyalgia, run by Insel Gruppe AG, University Hospital Bern.
Trial summary
Chronic pain is a major health problem and it has been estimate to account for approximately 40% of all medical visits, costing more than $600 billion annually in the United States alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Virtual reality heart and Standard therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Dec 2019to 1 Oct 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
- A diagnosis of fibromyalgia according to current diagnostic criteria
- Aged > 18 years old
- Capable of judgement
- Willing to participate in the study (by signing the informed consent form)
- Able to follow the study protocol
Who cannot join
- Presence of psychosis or major depression with suicidal risk
- History of alcohol or drug abuse
- Inability to follow the procedures of the study, e.g. due to language problems, inability to wear head-mounted display
- Arrythmia, such as atrial fibrillation
About this study
Chronic pain is a major health problem and it has been estimate to account for approximately 40% of all medical visits, costing more than $600 billion annually in the United States alone. Given that pharmacological and non-pharmacological treatments for chronic pain are often difficult and may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option. Recent findings from cognitive neuroscience show that it is possible to manipulate the body schema and to induce a range of well-controlled illusory bodily experiences by exposing participants to conflicting multisensory bodily inputs using VR, that are associated with changes in pain perception and somatosensory processing in healthy subjects and chronic pain patients. In the current project the investigators plan to follow up on these findings in patients suffering from chronic pain affecting the whole body, e.g. fibromyalgia. The project is planned as a single center clinical study at the Department of Neurology and Psychosomatic Medicine, Inselspital Bern, in cooperation with the Pain Center Inselspital Bern, the Department of Biomedical Engineering; University Bern and the Department of Psychology, University of Bern. The investigators want to explore the analgesic effect of a specific multisensory illusion (e.g. the cardio-visual illusion) in patients suffering from chronic pain as compared to a control condition (single-blinded, randomized clinical trial) using psychometric and algometric methods. Moreover, the investigators would like to assess the physiological changes associated with pain reduction, study the reduction of psychological distress and improved well-being and assess the subjective acceptance of VR as a possible treatment option for patients with chronic pain. Importantly, the investigators plan to develop and test an easy to use, mobile VR setup as a long-term treatment option for patients with chronic pain. Given that chronic pain is a major health problem, the investigators believe that there is a huge market potential for an easy to use, noninvasive and effective treatment option and a possible technology transfer.
- Conditions
- Fibromyalgia
- Being tested
- Virtual reality heart, Virtual reality control, Standard therapy
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality heartDevice
Patients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD.
We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off SYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity.
Virtual reality controlDevice
Patients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD.
We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off ASYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity.
Standard therapyOther
Standard multimodal out-patient therapy program (psychological support, physiotherapy, ergotherapy).
| Study group | Role | What they receive |
|---|---|---|
| VR heart | Experimental | Not described Receives: Device: Virtual reality heart; Other: Standard therapy |
| VR control | Sham comparator | Not described Receives: Device: Virtual reality control; Other: Standard therapy |
| Standard control | Active comparator | Not described Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception using numeric rating scale VR therapy vs. standard therapy
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using a numeric rating scale (0-10; 0=no pain, 10= max. pain)
Measured: 6 weeks
Pain perception using patient global impression of change VR therapy vs. standard therapy
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using the Patient global impression of change questionnaire (1-7; 1=very much improved, 7=very much worse).
Measured: 6 weeks
Pain perception (algometry) VR therapy vs. standard therapy
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using an Algometer:
The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity.
Measured: 6 weeks
Pain perception (algopeg) VR therapy vs. standard therapy
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using Algopeg:
The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test. For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable. The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold. The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable". High NRS values correspond with high pain sensitivity/hyperalgesia.
Measured: 6 weeks
Secondary outcomes (11)
Pain perception (numeric rating scale) VR therapy vs. VR control
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using Numeric rating scale (0-10; 0=no pain, 10= max. pain).
Measured: 6 weeks and 10 weeks
Pain perception (patient global impression of change) VR therapy vs. VR control
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using the Patient global impression of change questionnaire (1-7; 1=very much improved, 7=very much worse)
Measured: 6 weeks and 10 weeks
Pain perception (algometric) VR therapy vs. VR control
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algometry:
The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity.
Measured: 6 weeks and 10 weeks
Pain perception (algopeg) VR therapy vs. VR control
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algopeg:
The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test. For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable. The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold. The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable". High NRS values correspond with high pain sensitivity/hyperalgesia.
Measured: 6 weeks and 10 weeks
Heart rate variability
Inter-beat intervals are calculated as the time between two successive R spikes using the ECG signals as acquired during CV stimulation. Raw data are processed in Matlab® (The MathWorks Inc., Natick, USA) with the HRV Analysis Software (HRVAS: HRV Analysis Software). For each subject and each condition, we calculate the square root of the mean squared differences of successive beats intervals (RMSSD), which estimates the short term components of HRV and is commonly used over short recording periods. As HRV pain-related changes occurs mainly in high frequencies (i.e. power spectrum between 0.15 to 0.40 Hz), we then compute frequency-domain HRV analysis and calculated the power spectrum density using Welch's methods for Fast-Fourier Transform.
Measured: During each intervention, up to 6 weeks
Hamilton anxiety and and depression scale (HADS)
Study the reduction of psychological distress measured through the Hamilton anxiety and depression scale (Score Anxiety 0-7 normal, 8-10 borderline, 11-21 abnormal; Score depression 0-7 normal, 8-10 borderline, 11-21 abnormal)
Measured: 6 weeks and 10 weeks
Beck depression inventory (BDI II)
Study the reduction of psychological distress measured through the Beck depression inventory. BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The standardized cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.
Measured: 6 weeks and 10 weeks
WHO 5 Well Being Index
Study well-being through the WHO 5 Well Being Index.
The WHO-5 consists of five statements, which respondents rate according to the scale below (in relation to the past two weeks).
All of the time = 5, At no time = 0.
The total raw score, ranging from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measured: 6 weeks and 10 weeks
Pain perception (numeric rating scale)
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using the numeric rating scale (0-10; 0=no pain, 10= max. pain).
Measured: After each intervention, up to 6 weeks
Pain perception (algometer)
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algometry:
The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity.
Measured: After each intervention, up to 6 weeks
Pain perception (algopeg)
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to a VR control condition using algopeg. The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test. For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable. The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold. The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable". High NRS values correspond with high pain sensitivity/hyperalgesia.
Measured: After each intervention, up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start17 Dec 2019
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Why it stopped: Lack of participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lukas Heydrich, MDPhD, Principal investigator, Inselspital Bern, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108702
- Sponsor's protocol ID
- 2019-01515
- Other IDs
- 2019
- Status last verified
- Feb 2023
- First submitted
- 15 Aug 2019
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality as a New Therapeutic Tool for Chronic Pain
- ClinicalTrials.gov ID
- NCT04108702
- Acronym / sponsor ID
- 2019-01515
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 30 Sep 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.
Chronic pain is a major health problem and it has been estimate to account for approximately 40% of all medical visits, costing more than $600 billion annually in the United States alone. Given that pharmacological and non-pharmacological treatments for chronic pain are often difficult and may be associated with limiting side effects, technology-based interventions using virtual reality (VR) may be a promising alternative treatment option. Recent findings from cognitive neuroscience show that it is possible to manipulate the body schema and to induce a range of well-controlled illusory bodily experiences by exposing participants to conflicting multisensory bodily inputs using VR, that are associated with changes in pain perception and somatosensory processing in healthy subjects and chronic pain patients. In the current project the investigators plan to follow up on these findings in patients suffering from chronic pain affecting the whole body, e.g. fibromyalgia. The project is planned as a single center clinical study at the Department of Neurology and Psychosomatic Medicine, Inselspital Bern, in cooperation with the Pain Center Inselspital Bern, the Department of Biomedical Engineering; University Bern and the Department of Psychology, University of Bern. The investigators want to explore the analgesic effect of a specific multisensory illusion (e.g. the cardio-visual illusion) in patients suffering from chronic pain as compared to a control condition (single-blinded, randomized clinical trial) using psychometric and algometric methods. Moreover, the investigators would like to assess the physiological changes associated with pain reduction, study the reduction of psychological distress and improved well-being and assess the subjective acceptance of VR as a possible treatment option for patients with chronic pain. Importantly, the investigators plan to develop and test an easy to use, mobile VR setup as a long-term treatment option for patients with chronic pain. Given that chronic pain is a major health problem, the investigators believe that there is a huge market potential for an easy to use, noninvasive and effective treatment option and a possible technology transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR heart | Experimental | Device: Virtual reality heart, Other: Standard therapy |
| VR control | Sham comparator | Device: Virtual reality control, Other: Standard therapy |
| Standard control | Active comparator | Other: Standard therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A diagnosis of fibromyalgia according to current diagnostic criteria
- Aged > 18 years old
- Capable of judgement
- Willing to participate in the study (by signing the informed consent form)
- Able to follow the study protocol
Key exclusion criteria (4 listed)
- Presence of psychosis or major depression with suicidal risk
- History of alcohol or drug abuse
- Inability to follow the procedures of the study, e.g. due to language problems, inability to wear head-mounted display
- Arrythmia, such as atrial fibrillation
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 |
|---|---|---|
| Virtual reality heartPatients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD. We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off SYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity. | Device | VR heart |
| Virtual reality controlPatients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD. We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off ASYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity. | Device | VR control |
| Standard therapyStandard multimodal out-patient therapy program (psychological support, physiotherapy, ergotherapy). | Other | Standard control, VR control, VR heart |
Primary outcome
Pain perception using numeric rating scale VR therapy vs. standard therapy
Time frame: 6 weeks
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using a numeric rating scale (0-10; 0=no pain, 10= max. pain)
Pain perception using patient global impression of change VR therapy vs. standard therapy
Time frame: 6 weeks
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using the Patient global impression of change questionnaire (1-7; 1=very much improved, 7=very much worse).
Pain perception (algometry) VR therapy vs. standard therapy
Time frame: 6 weeks
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using an Algometer: The Pain pressure detection threshold to determine hypersensitivity to pain is measured with a standard electronic algometer (Somedic Type II) by bilateral testing on the middle fingers. The electronic algometer is calibrated following the standard protocol as recommended by the manufacturer and set to deliver a steadily increasing pressure (50 kilopascal for 1 s). In this method, the investigators check for the threshold at which non-painful perception of pressure changes to painful perception in response to the gradually increased pressure applied. Low thresholds correspond to high pain sensitivity.
Pain perception (algopeg) VR therapy vs. standard therapy
Time frame: 6 weeks
Explore the analgesic effect of the cardio-visual illusion in patients suffering from chronic pain as compared to standard therapy (single-blinded, randomized clinical trial) after 6 weeks using Algopeg: The algometric measurement method to detect hyperalgesia will be carried out by means of a pressure pain provocation test. For this type of algometry, we will use a standardized peg with a clamping force of exactly 10 Newton at an extension of 5 mm (Type Algopeg).The pressure is applied on the middle finger and the ear lobes for 10 s each and is invariable. The pegs pressure exerted on an ear lobe is perceived as being consistently and clearly above the pain threshold. The patient indicates the pain intensity on a numerical rating scale (NRS) on which 0 stands for "no pain" and 10 stands for "the most intense pain imaginable". High NRS values correspond with high pain sensitivity/hyperalgesia.
11 secondary outcomes
Pain perception (numeric rating scale) VR therapy vs. VR control
Time frame: 6 weeks and 10 weeks
Pain perception (patient global impression of change) VR therapy vs. VR control
Time frame: 6 weeks and 10 weeks
Pain perception (algometric) VR therapy vs. VR control
Time frame: 6 weeks and 10 weeks
Pain perception (algopeg) VR therapy vs. VR control
Time frame: 6 weeks and 10 weeks
Heart rate variability
Time frame: During each intervention, up to 6 weeks
Hamilton anxiety and and depression scale (HADS)
Time frame: 6 weeks and 10 weeks
Beck depression inventory (BDI II)
Time frame: 6 weeks and 10 weeks
WHO 5 Well Being Index
Time frame: 6 weeks and 10 weeks
Pain perception (numeric rating scale)
Time frame: After each intervention, up to 6 weeks
Pain perception (algometer)
Time frame: After each intervention, up to 6 weeks
Pain perception (algopeg)
Time frame: After each intervention, up to 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- 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.
Lukas Heydrich, MDPhD principal investigator
Inselspital Bern, University of Bern
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality heart and Standard therapy in people with Fibromyalgia, run by Insel Gruppe AG, University Hospital Bern.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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 perception using numeric rating scale VR therapy vs. standard therapy (time frame: 6 weeks). 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 13 Feb 2023.