Lower Back PainNCT04887285
Virtual Reality as a Substitute for Procedural Sedation During Epidural Steroid Injections
A study testing Virtual reality and Intravenous sedation in people with Lower Back Pain and Lumbar Radiculopathy, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lower Back Pain, Lumbar Radiculopathy
- What is being tested?
- Virtual reality and Intravenous sedation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females; ages 18-90 years
- Lumbosacral radicular pain with a baseline average of leg pain score of > 4/10, MRI findings (if available) consistent with symptoms, duration of pain > 6 weeks, and no previous lumbar spine surgery.
- Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease
- Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality
- Able to appear for a follow up visit between 24-40 days following the intervention
Who cannot join
- MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms)
- Previous lumbosacral spine surgery at the area affected
- Prior ESI within the past 6 months
- Allergy to contrast dye
- Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation)
- Morbid obesity (BMI >40)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions
Baltimore, Maryland, 21205
About this study
Official title: Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial
This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.
Read the detailed description
All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transforaminal or interlaminar depending on clinical judgment (i.e. transforaminal ESI for unilateral pain, interlaminar ESI for bilateral pain). The study will consist of 3 groups: virtual reality, sedation, and a control group which receives no intervention (i.e. standard of care). The virtual reality group will receive virtual reality via a headset containing a menu of 6 programs that the subject can choose; the sedation group will receive from 1-5 mg of midazolam and up to 150 mcg of fentanyl as clinically indicated, and the control group will not receive an intervention (standard of care). All subjects will also receive 1% lidocaine local anesthetic through a 25-gauge needle for superficial anesthesia, which is standard of care. Subjects will be randomized to each of these groups, with sub-allocation being done stratified by the type of ESI (transforaminal vs. interlaminar).
A secondary pilot study will evaluate whether a processed electroencephalogram (pEEG) and continuous colored density spectral array monitored via a four-channel Masimo SEDLine frontal EEG sensor can serve as a biomarker for painful stimulation and the effectiveness of distraction and sedation to reduce acute pain.
- Conditions
- Lower Back Pain, Lumbar Radiculopathy
- Being tested
- Virtual reality, Intravenous sedation, Standard care
- Keywords
- epidural steroid injection, virtual reality, distraction, sedation, lumbar radiculopathy
- Medical subject headings
- Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
Subjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic.
Intravenous sedationDrug
Sedation will be administered using low-dose midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli.
Standard careOther
Also called Local anesthetic only
Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality (VR) | Experimental | Subjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. They will also receive 1% superficial anesthesia. Receives: Device: Virtual reality |
| Sedation | Active comparator | Conscious sedation will be accomplished by the use of midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). All medications will be titrated to conscious sedation by a board-certified anesthesiologist. Subjects will also receive 1% superficial anesthesia. Receives: Drug: Intravenous sedation |
| Standard care | Other | Patients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score During Procedure
0-10 verbal rating scale (higher scores indicate greater pain)
Measured: Immediately after procedure
Secondary outcomes (18)
Amount of Local Anesthetic Required
Volume of 1% lidocaine used to complete the skin wheel prior to the procedure.
Measured: At the start of the procedure
Subcutaneous Skin Wheal Pain Score
0-10 verbal rating scale (higher scores indicate greater pain)
Measured: Immediately after skin wheal
Procedure Satisfaction
This outcome was measured using a standalone question using the 1-5 Likert scale (1= very unsatisfied, 3= neither satisfied nor dissatisfied, 5= very satisfied). A mean of the participant selection is reported.
Measured: In postanesthetic care unit (within 1 hour)
Ability to Communicate
This outcome was measured using a standalone question using the 1-5 Likert scale (1= complete inability to communicate, 2= markedly decreased ability to communicate, 3= slightly decreased ability to communicate, 4= no change in ability to communicate, 5= improved ability to communicate). A mean of the participant selection is reported.
Measured: In postanesthetic care unit (within 1 hour)
Procedure-related Anxiety
This outcome was measured using a standalone question using the 1-5 Likert scale (1=extreme anxiety, 2=high anxiety, 3=average or expected anxiety, 4=minimal or mild anxiety, 5=no anxiety. A mean of the participant selection is reported.
Measured: In postanesthetic care unit (within 1 hour)
Time to Discharge From Postanesthetic Care Unit
Time to discharge from postanesthetic care unit, in minutes
Measured: At discharge from postanesthetic care unit assessed up to 6 hours
Participants With Positive Categorical Outcome
This outcome measure is either positive or negative. A positive outcome is measured by participants with a 2-point or greater reduction in average leg pain score coupled with participants with a score of 5 or greater score on the Patient Global Impression of Change (PGIC), or negative is measure by a 1 or no point reduction in the average leg pain score couple with a 4 or less score on the Patient Global Impression of Change (PGIC). The average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain). The Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference). Participants with positive outcome are reported.
Measured: 4 weeks
Average Leg Pain Score
Average leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Measured: 4 weeks
Worst Leg Pain Score
Worst leg pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Measured: 4 weeks
Average Back Pain Score
Average back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Measured: 4 weeks
Worst Back Pain Score
Worst back pain score on 0-10 numerical rating scale over the last week (higher pain scores indicate greater pain)
Measured: 4 weeks
Patient Global Impression of Change (PGIC)
Patient global impression of change on 7-point Likert scale (from 1= no change, 3= a little better 5= moderately better, a slight but noticeable change, to 7=a great deal better, a considerable improvement that has made all the difference)
Measured: 4 weeks
Number of Participants With Analgesic Reduction
Categorical reduction in analgesic usage (cessation of non-opioid analgesic and/ or > 20% reduction in opioid use)
Measured: 4 weeks
Oswestry Disability Index (ODI) Score
Functional measurement of back and leg pain disability on 0-100% scale (higher levels indicate greater disability)
Measured: 4 weeks
Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions
The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Anxiety score is reported.
Measured: 4 weeks
Number of Participants With Complications
Number of Participants With Complications related to the procedure, sedation or use of virtual reality
Measured: 4 weeks
Percentage Change of the Spectral Edge Frequency (SEF)
Frontal EEG sensor will be placed with electrode positions corresponding to Fp1, Fp2, F7, and F8 in the international 10-20 system. The spectral edge frequency (SEF) on the Sedline monitor ranges in frequency from 0 to 30 Hz.
Measured: During the procedure for up to 20 minutes
Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety
The Hospital anxiety and depression scale (HADS) is an instrument used to measure depression and anxiety. Anxiety and depression are scored separately, each on a subscale. The score on each subscale ranges from 0 to 21 score on a scale. A score of 0 indicates the absence of depression or anxiety. A score of 21 indicated severe depression or anxiety. The subscales are not combined for a total score. Depression score is reported.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start28 Mar 2022
- Primary completion15 Aug 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel study comparing virtual reality to sedation to standard care (no sedation or virtual reality) for procedure-related pain in patients undergoing lumbar epidural steroid injections.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Geneva Foundation, Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, Brigham and Women's Hospital
- Responsible party
- Sponsor
- Investigators
- Whitley Lucio, Study director, Walter Reed National Military Medical CenterSteven P Cohen, MD, Principal investigator, Johns Hopkins Uinversity - SOM Ane PainNuj Tontisirin, MD, Study director, Ramathibodi Hospital, Mahidol UniversityPornpan Chalermkitpanit, MD, Study director, King Chulalongkorn Memorial Hospital, Chulalongkorn UniversityPramote Euasobhon, MD, Study director, Siriraj HospitalSithapan Munjupong, MD, Study director, Phramongkutklao College of MedicineQian Chen, MD, Study director, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04887285
- Sponsor's protocol ID
- IRB00255275
- Other IDs
- HU00011920011
- Status last verified
- Nov 2024
- First submitted
- 7 May 2021
- Last updated
- 2 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Protocol, Informed Consent Form, deidentified data and statistical code.
Publications
Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
PubMed 29485536Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
PubMed 31308733
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Distraction Substitute for Procedural Sedation and Improve Tolerance in Patients Receiving Epidural Steroid Injection for Pain? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04887285
- Acronym / sponsor ID
- IRB00255275
- Conditions
- Lower Back Pain, Lumbar Radiculopathy
- Keywords
- epidural steroid injection, virtual reality, distraction, sedation, lumbar radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Geneva Foundation, Walter Reed National Military Medical Center, United States Naval Medical Center, San Diego, Brigham and Women's Hospital
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 14 May 2021 (actual)
- Results
- Posted 26 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the impact of virtual reality compared to sedation (midazolam and/or fentanyl) and no intervention on pain experienced from an epidural steroid injection (ESI). The intervention group (who receive virtual reality as a distraction modality) is compared to a sedation group and a control group.
Detailed description
All patients enrolled in the study will already be undergoing lumbar epidural steroid injections for lumbar radicular pain as part of their clinical care. The epidural approach will either be transforaminal or interlaminar depending on clinical judgment (i.e. transforaminal ESI for unilateral pain, interlaminar ESI for bilateral pain). The study will consist of 3 groups: virtual reality, sedation, and a control group which receives no intervention (i.e. standard of care). The virtual reality group will receive virtual reality via a headset containing a menu of 6 programs that the subject can choose; the sedation group will receive from 1-5 mg of midazolam and up to 150 mcg of fentanyl as clinically indicated, and the control group will not receive an intervention (standard of care). All subjects will also receive 1% lidocaine local anesthetic through a 25-gauge needle for superficial anesthesia, which is standard of care. Subjects will be randomized to each of these groups, with sub-allocation being done stratified by the type of ESI (transforaminal vs. interlaminar).
A secondary pilot study will evaluate whether a processed electroencephalogram (pEEG) and continuous colored density spectral array monitored via a four-channel Masimo SEDLine frontal EEG sensor can serve as a biomarker for painful stimulation and the effectiveness of distraction and sedation to reduce acute pain.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel study comparing virtual reality to sedation to standard care (no sedation or virtual reality) for procedure-related pain in patients undergoing lumbar epidural steroid injections.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality (VR) | Experimental | Device: Virtual realitySubjects in the VR group will be fitted with an HTC headset and headphones with disposable ear covers. They will choose from a menu of 6 different programs. They will also receive 1% superficial anesthesia. |
| Sedation | Active comparator | Drug: Intravenous sedationConscious sedation will be accomplished by the use of midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). All medications will be titrated to conscious sedation by a board-certified anesthesiologist. Subjects will also receive 1% superficial anesthesia. |
| Standard care | Other | Other: Standard carePatients in this arm will be administered only 1% lidocaine as superficial anesthesia, similar to the other 2 arms. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males and females; ages 18-90 years
- Lumbosacral radicular pain with a baseline average of leg pain score of > 4/10, MRI findings (if available) consistent with symptoms, duration of pain > 6 weeks, and no previous lumbar spine surgery.
- Documented diagnosis of radicular pain caused by herniated disc, central stenosis, foraminal stenosis, degenerative disk disease
- Willingness to adhere to undergo ESI with either sedation (midazolam and or fentanyl) or with virtual reality
- Able to appear for a follow up visit between 24-40 days following the intervention
Key exclusion criteria (6 listed)
- MRI findings discordant with symptoms (absence of herniated disc, spinal stenosis or severe disc degeneration without nerve root impingement (e.g. annular tears) that could explain symptoms)
- Previous lumbosacral spine surgery at the area affected
- Prior ESI within the past 6 months
- Allergy to contrast dye
- Poorly controlled psychiatric conditions that could affect outcomes (e.g. active substance abuse) or impose a barrier to participation (e.g. anxiety disorder requiring procedural sedation)
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 realitySubjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic. | Device | Virtual reality (VR) |
| Intravenous sedationSedation will be administered using low-dose midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli. | Drug | Sedation |
| Standard careAlso: Local anesthetic onlyPatients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort. | Other | Standard care |
Primary outcome
Pain Score During Procedure
Time frame: Immediately after procedure
0-10 verbal rating scale (higher scores indicate greater pain)
18 secondary outcomes
Amount of Local Anesthetic Required
Time frame: At the start of the procedure
Subcutaneous Skin Wheal Pain Score
Time frame: Immediately after skin wheal
Procedure Satisfaction
Time frame: In postanesthetic care unit (within 1 hour)
Ability to Communicate
Time frame: In postanesthetic care unit (within 1 hour)
Procedure-related Anxiety
Time frame: In postanesthetic care unit (within 1 hour)
Time to Discharge From Postanesthetic Care Unit
Time frame: At discharge from postanesthetic care unit assessed up to 6 hours
Participants With Positive Categorical Outcome
Time frame: 4 weeks
Average Leg Pain Score
Time frame: 4 weeks
Worst Leg Pain Score
Time frame: 4 weeks
Average Back Pain Score
Time frame: 4 weeks
Worst Back Pain Score
Time frame: 4 weeks
Patient Global Impression of Change (PGIC)
Time frame: 4 weeks
Number of Participants With Analgesic Reduction
Time frame: 4 weeks
Oswestry Disability Index (ODI) Score
Time frame: 4 weeks
Hospital Anxiety and Depression Scale (HADS) Scores for Anxiety and Depressions
Time frame: 4 weeks
Number of Participants With Complications
Time frame: 4 weeks
Percentage Change of the Spectral Edge Frequency (SEF)
Time frame: During the procedure for up to 20 minutes
Hospital Anxiety and Depression Scale (HADS) Scores for Depression and Anxiety
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29485536Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599.
- Results publication: PubMed 31308733Mallari B, Spaeth EK, Goh H, Boyd BS. Virtual reality as an analgesic for acute and chronic pain in adults: a systematic review and meta-analysis. J Pain Res. 2019 Jul 3;12:2053-2085. doi: 10.2147/JPR.S200498. eCollection 2019.
- Individual participant dataSharing planned: Yes. Protocol, Informed Consent Form, deidentified data and statistical code.
Related trials for Lower Back Pain
Not yet recruitingPhase 3
Veterans' Intervention Blending NeuRomodulation and YogA for Chronic Low BackPaiN Treatment: VIBRANT
Chronic Low Back Pain, Musculoskeletal Pain
Not yet recruitingPhase 2
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
Chronic Low Back Pain (CLBP), Physical Therapy
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
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.
Whitley Lucio study director
Walter Reed National Military Medical Center
Steven P Cohen, MD principal investigator
Johns Hopkins Uinversity - SOM Ane Pain
Nuj Tontisirin, MD study director
Ramathibodi Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality and Intravenous sedation in people with Lower Back Pain and Lumbar Radiculopathy, run by Johns Hopkins University at 1 site in United States.
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 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 26 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Score During Procedure (time frame: Immediately after procedure). 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 NCT04887285, which also lists 2 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 2 Dec 2024.