Localized Provoked VulvodyniaNCT02892214
The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia
An observational study of Localized Provoked Vulvodynia, run by Meir Medical Center at 1 site in Israel.
Trial summary
The proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Localized Provoked Vulvodynia
- What is being tested?
- Pelvic floor physical therapy, estriol cream (ovestin) and Low-level-laser therapy
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Nov 2016to Dec 2021
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem.
Who may be able to join
- A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
- On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
- No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.
Who cannot join
- other causes for vulvar pain
- pregnancy or a planned pregnancy in the upcoming year
- diagnosis of chronic disease that may affect central nervous system or general function.
- usage of psychiatric medications or those affecting pain modulation.
- unprovoked or mixed vulvodynia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient
The proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional health and sexual functioning.
Read the detailed description
Provoked vestibulodynia (PVD) is the term describing a syndrome of provoked, localized allodynia of the vestibule of the vulva, not explained by another condition, and lasting more than 3 months. PVD is not a defined disease but rather a symptom. It is thought that PVD represent a group of distinct disorders that have been classified together because they produce pain in the same anatomic location.
Studies found that different factors such as genetic, inflammation, recurrent vaginitis, allergy, trauma, emotional and neural may be involved in the development of PVD.
Treatment of PVD is generally predicated on a trial and error basis, because the pathogenesis is not defined. The result is that many forms of therapeutic interventions have been used, yet the evidence remains largely inconclusive, the response rates varies considerably, and many women do not respond to any of the treatments. It is therefore important to recognize which factors mediate the syndrome's severity, and influence the effectiveness of treatments.
The proposed study will evaluate how different patients' characteristics (personality, cognitive) and responses (emotional and behavioral) influence the natural history of the syndrome and the response to treatment. The study is based on the bio-psycho-social model and the adult attachment theory, which integrates psychosocial factors to define susceptibility to acquire pain disorders and predict response to therapy. According to this model, choosing effective coping strategy during a crisis and receiving support from a spouse are vital for recovery.
The study aim to:
- Characterize interactions between attachment patterns, personality types, cognitive factors (catastrophization, coherence, and partner's support), emotional factors (coping strategies, emotional stress and satisfaction from intimate relationship) to pain levels, pelvic floor hypertonicity, sexual function and patient's emotional health.
- Examine whether treatments' results are influenced by personality, relationship, cognitive, emotional and behavioral characteristics of the patient.
- Recognize factors that influence the extent of adherence to treatment.
- Characterize patients' profile in regard to successful outcome.
Methods Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem. The diagnostic procedures, patients' sub-classification and the proposed treatments in the current protocol are identical to those currently used in the clinic. Each patient will undergo a standard evaluation which includes: detailed history intake, vulvar and vaginal examination, evaluation of vestibular tenderness (Q tip test), pelvic floor musculature tenderness examination, vaginal pH measurement, saline and 10% potassium hydroxide microscopy, yeast and bacterial cultures and STD screening.
Patients who fulfill diagnostic criteria of PVD and who will be willing to participate in the study will be asked to sign an informed consent and complete the following self-administered intake questionnaires:
- Socio-demographic questionnaire (age, marital status, religios, PVD onset, health status, education etc.)
- Close Relations Experiences questionnaire
- Five Factor Inventory -NEO-FFI
- Pain catastrophizing questionnaire
- Sense of Coherence Scale
- Ways of giving support questionnaire
- COPE -Multidimensional Coping Inventory
- Semantic Differential Measure of Marital Satisfaction
- PSS-10 - Perceived Stress Scale
- FSFI-Female Sexual Function Index
Instructions for treatment will be given in regards to the diagnosis. Patients will be instructed to schedule follow-up appointments at 3,6,9, and 12 months. During follow-up appointments they will be assessed in regard to vestibular tenderness (using various parameters), as well as by the same questionnaires. Additional treatment will be recommended according to medical status, in an identical way to this routinely used in the clinic.
- Conditions
- Localized Provoked Vulvodynia
- Being tested
- Pelvic floor physical therapy, estriol cream (ovestin), Low-level-laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor physical therapyProcedure or surgery
estriol cream (ovestin)Drug
Low-level-laser therapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic pelvic muscle dysfunction | In this subgroup, pelvic floor (PF) muscles become tight and tender. Typically, the pain is much worse at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule. Receives: Procedure: Pelvic floor physical therapy | |
| Hormonally mediated PVD | The pain began while taking hormonal contraceptive or other medications that affect hormones, after removal of ovaries, breastfeeding or menopause. The entire vestibule is tender and vestibular mucosa is often dry and thin. Receives: Drug: estriol cream (ovestin) | |
| Neuroproliferative PVD | In this condition, we speculate that women have an increased number of nociceptors in the vestibular mucosa. Pain is primary and there is tenderness of the entire vestibule. Receives: Procedure: Low-level-laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of measure of Q tip test assessing pain intensity
The exam is performed by touching the vestibule with a cotton-tip applicator in 6 defined points (2,5,6,7, 10 and 12),while the patient is being asked to rate the intensity of pain verbally from 0 to 10 at each point.
Measured: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months
Secondary outcomes (6)
Measurement of vestibular tenderness using a vulvar algesiometer
Measured: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Change of pain using Visual analog scale
Measured: Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months
Adherence to therapy
Adherence to therapy will be assessed by calculating attendance to planed appointments (physical therapy, medical appointments and LLL treatments)
Measured: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Female sexual function index questionnaire
Measured: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Pelvic floor hypertonicity measurements
Pelvic floor muscle tonicity will be evaluated using manual palpation of the muscles by the physician.
Measured: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Brief Symptom Inventory-18 questionnaire (evaluating emotional symptoms)
Measured: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start30 Nov 2016
- Primary completionDec 2020
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Localized Provoked VulvodyniaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahinoam Lev-Sagie, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892214
- Sponsor's protocol ID
- 0089-16-COM1
- Status last verified
- Apr 2022
- First submitted
- 2 Sep 2016
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Andrews JC. Vulvodynia interventions--systematic review and evidence grading. Obstet Gynecol Surv. 2011 May;66(5):299-315. doi: 10.1097/OGX.0b013e3182277fb7.
PubMed 21794194Antonovsky, A. (1987). How people manage stress and stay well. San Francisco, CA, US: Jossey-Bass Unraveling the mystery of health.
Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer HI, Meana M, Amsel R. A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001 Apr;91(3):297-306. doi: 10.1016/S0304-3959(00)00449-8.
PubMed 11275387Bergeron S, Brown C, Lord MJ, Oala M, Binik YM, Khalife S. Physical therapy for vulvar vestibulitis syndrome: a retrospective study. J Sex Marital Ther. 2002 May-Jun;28(3):183-92. doi: 10.1080/009262302760328226.
PubMed 11995597Brennan, K.A., Clark, C.L., & Shaver P.R. (1998). Self-report measurement of adult attachment: An integrative overview. In J.A. Simpson & W.S. Rholes (Eds.), Attachment theory and close relationships, (pp. 46-76). NY,US: Guilford Press.
Buunk, B. P., Berkhuysen, M. A., Sanderman, R., Nieuwland, W., & Ranchor, A. V. (1996). Active engagement, protective buffering and overprotection: Instruments to measure the role of the spouse in heart rehabilitation. Gedrag & Gezondheid, 24, 304- 113.
Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
PubMed 2926629Cohen, S., & Spacapan, S. (1978). The aftereffects of stress: An attentional interpretation. Environmental Psychology and Nonverbal Behavior, 3(1), 43-57.
Meredith P, Ownsworth T, Strong J. A review of the evidence linking adult attachment theory and chronic pain: presenting a conceptual model. Clin Psychol Rev. 2008 Mar;28(3):407-29. doi: 10.1016/j.cpr.2007.07.009. Epub 2007 Jul 19.
PubMed 17719157Sadownik LA. Clinical profile of vulvodynia patients. A prospective study of 300 patients. J Reprod Med. 2000 Aug;45(8):679-84.
PubMed 10986689Sullivan, M. J. L., Bishop, S., & Pivic, J. (1995). The pain catastrophizing scale: Development and validation. Psychological Assessment, 7, 524-532.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reciprocal Relations Between Psychosocial Characteristics and the Progression of Vestibulodynia, and the Mental Health of the Patient
- ClinicalTrials.gov ID
- NCT02892214
- Acronym / sponsor ID
- 0089-16-COM1
- Conditions
- Localized Provoked Vulvodynia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 8 Sep 2016 (estimated)
- 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 proposed study will evaluate how personality characteristics, cognitive factors and the emotional and behavioral responses of patients with provoked vestibulodynia (localized provoked vulvodynia) influence the natural history of the syndrome, patients' adherence to therapeutic interventions, provoked pain levels, pelvic floor rehabilitation, emotional health and sexual functioning.
Detailed description
Provoked vestibulodynia (PVD) is the term describing a syndrome of provoked, localized allodynia of the vestibule of the vulva, not explained by another condition, and lasting more than 3 months. PVD is not a defined disease but rather a symptom. It is thought that PVD represent a group of distinct disorders that have been classified together because they produce pain in the same anatomic location.
Studies found that different factors such as genetic, inflammation, recurrent vaginitis, allergy, trauma, emotional and neural may be involved in the development of PVD.
Treatment of PVD is generally predicated on a trial and error basis, because the pathogenesis is not defined. The result is that many forms of therapeutic interventions have been used, yet the evidence remains largely inconclusive, the response rates varies considerably, and many women do not respond to any of the treatments. It is therefore important to recognize which factors mediate the syndrome's severity, and influence the effectiveness of treatments.
The proposed study will evaluate how different patients' characteristics (personality, cognitive) and responses (emotional and behavioral) influence the natural history of the syndrome and the response to treatment. The study is based on the bio-psycho-social model and the adult attachment theory, which integrates psychosocial factors to define susceptibility to acquire pain disorders and predict response to therapy. According to this model, choosing effective coping strategy during a crisis and receiving support from a spouse are vital for recovery.
The study aim to:
- Characterize interactions between attachment patterns, personality types, cognitive factors (catastrophization, coherence, and partner's support), emotional factors (coping strategies, emotional stress and satisfaction from intimate relationship) to pain levels, pelvic floor hypertonicity, sexual function and patient's emotional health.
- Examine whether treatments' results are influenced by personality, relationship, cognitive, emotional and behavioral characteristics of the patient.
- Recognize factors that influence the extent of adherence to treatment.
- Characterize patients' profile in regard to successful outcome.
Methods Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem. The diagnostic procedures, patients' sub-classification and the proposed treatments in the current protocol are identical to those currently used in the clinic. Each patient will undergo a standard evaluation which includes: detailed history intake, vulvar and vaginal examination, evaluation of vestibular tenderness (Q tip test), pelvic floor musculature tenderness examination, vaginal pH measurement, saline and 10% potassium hydroxide microscopy, yeast and bacterial cultures and STD screening.
Patients who fulfill diagnostic criteria of PVD and who will be willing to participate in the study will be asked to sign an informed consent and complete the following self-administered intake questionnaires:
- Socio-demographic questionnaire (age, marital status, religios, PVD onset, health status, education etc.)
- Close Relations Experiences questionnaire
- Five Factor Inventory -NEO-FFI
- Pain catastrophizing questionnaire
- Sense of Coherence Scale
- Ways of giving support questionnaire
- COPE -Multidimensional Coping Inventory
- Semantic Differential Measure of Marital Satisfaction
- PSS-10 - Perceived Stress Scale
- FSFI-Female Sexual Function Index
Instructions for treatment will be given in regards to the diagnosis. Patients will be instructed to schedule follow-up appointments at 3,6,9, and 12 months. During follow-up appointments they will be assessed in regard to vestibular tenderness (using various parameters), as well as by the same questionnaires. Additional treatment will be recommended according to medical status, in an identical way to this routinely used in the clinic.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertonic pelvic muscle dysfunction | – | Procedure: Pelvic floor physical therapyIn this subgroup, pelvic floor (PF) muscles become tight and tender. Typically, the pain is much worse at 4-8 o'clock position of the vestibule with minimal or no pain in the upper vestibule. |
| Hormonally mediated PVD | – | Drug: estriol cream (ovestin)The pain began while taking hormonal contraceptive or other medications that affect hormones, after removal of ovaries, breastfeeding or menopause. The entire vestibule is tender and vestibular mucosa is often dry and thin. |
| Neuroproliferative PVD | – | Procedure: Low-level-laser therapyIn this condition, we speculate that women have an increased number of nociceptors in the vestibular mucosa. Pain is primary and there is tenderness of the entire vestibule. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the clinic for vulvovaginal disorders in Clalit Healthcare services in Jerusalem.
Key inclusion criteria (3 listed)
- A history of 3 months or more of vulvar pain suggestive of PVD, i.e. symptoms of pain on vaginal penetration (insertional dyspareunia and/or pain with tampon insertion).
- On exam, tenderness localized within the vestibule when being touched with a cotton-tip applicator.
- No identifiable cause for the pain, such as vulvovaginal candidiasis, vaginal atrophy, desquamative inflammatory vaginitis (DIV), herpes, dermatitis or vulvar dystrophy.
Key exclusion criteria (5 listed)
- other causes for vulvar pain
- pregnancy or a planned pregnancy in the upcoming year
- diagnosis of chronic disease that may affect central nervous system or general function.
- usage of psychiatric medications or those affecting pain modulation.
- unprovoked or mixed vulvodynia
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 |
|---|---|---|
| Pelvic floor physical therapy | Procedure or surgery | Hypertonic pelvic muscle dysfunction |
| estriol cream (ovestin) | Drug | Hormonally mediated PVD |
| Low-level-laser therapy | Procedure or surgery | Neuroproliferative PVD |
Primary outcome
Change of measure of Q tip test assessing pain intensity
Time frame: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months
The exam is performed by touching the vestibule with a cotton-tip applicator in 6 defined points (2,5,6,7, 10 and 12),while the patient is being asked to rate the intensity of pain verbally from 0 to 10 at each point.
6 secondary outcomes
Measurement of vestibular tenderness using a vulvar algesiometer
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Change of pain using Visual analog scale
Time frame: Change in VAS between recruitment to 3 months, 6 months , 9 months and 12 months
Adherence to therapy
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Female sexual function index questionnaire
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Pelvic floor hypertonicity measurements
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
Brief Symptom Inventory-18 questionnaire (evaluating emotional symptoms)
Time frame: Every 3 months for 1 year- 0, 3 months, 6 months, 9 months and 12 months.
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 8 Apr 2022.
- Background: PubMed 21794194Andrews JC. Vulvodynia interventions--systematic review and evidence grading. Obstet Gynecol Surv. 2011 May;66(5):299-315. doi: 10.1097/OGX.0b013e3182277fb7.
- BackgroundAntonovsky, A. (1987). How people manage stress and stay well. San Francisco, CA, US: Jossey-Bass Unraveling the mystery of health.
- Background: PubMed 11275387Bergeron S, Binik YM, Khalife S, Pagidas K, Glazer HI, Meana M, Amsel R. A randomized comparison of group cognitive--behavioral therapy, surface electromyographic biofeedback, and vestibulectomy in the treatment of dyspareunia resulting from vulvar vestibulitis. Pain. 2001 Apr;91(3):297-306. doi: 10.1016/S0304-3959(00)00449-8.
- Background: PubMed 11995597Bergeron S, Brown C, Lord MJ, Oala M, Binik YM, Khalife S. Physical therapy for vulvar vestibulitis syndrome: a retrospective study. J Sex Marital Ther. 2002 May-Jun;28(3):183-92. doi: 10.1080/009262302760328226.
- BackgroundBrennan, K.A., Clark, C.L., & Shaver P.R. (1998). Self-report measurement of adult attachment: An integrative overview. In J.A. Simpson & W.S. Rholes (Eds.), Attachment theory and close relationships, (pp. 46-76). NY,US: Guilford Press.
- BackgroundBuunk, B. P., Berkhuysen, M. A., Sanderman, R., Nieuwland, W., & Ranchor, A. V. (1996). Active engagement, protective buffering and overprotection: Instruments to measure the role of the spouse in heart rehabilitation. Gedrag & Gezondheid, 24, 304- 113.
- Background: PubMed 2926629Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.
- BackgroundCohen, S., & Spacapan, S. (1978). The aftereffects of stress: An attentional interpretation. Environmental Psychology and Nonverbal Behavior, 3(1), 43-57.
- Background: PubMed 17719157Meredith P, Ownsworth T, Strong J. A review of the evidence linking adult attachment theory and chronic pain: presenting a conceptual model. Clin Psychol Rev. 2008 Mar;28(3):407-29. doi: 10.1016/j.cpr.2007.07.009. Epub 2007 Jul 19.
- Background: PubMed 10986689Sadownik LA. Clinical profile of vulvodynia patients. A prospective study of 300 patients. J Reprod Med. 2000 Aug;45(8):679-84.
- BackgroundSullivan, M. J. L., Bishop, S., & Pivic, J. (1995). The pain catastrophizing scale: Development and validation. Psychological Assessment, 7, 524-532.
- 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.
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?
An observational study of Localized Provoked Vulvodynia, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 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 8 Apr 2022. 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 Israel. 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?
Change of measure of Q tip test assessing pain intensity (time frame: Change in measure between recruitment to 3 months, 6 months , 9 months and 12 months). 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 NCT02892214, which also lists 11 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 8 Apr 2022.