Chronic Pelvic Pain SyndromeNCT05546203
Trigger Point Treatment in Chronic Pelvic Pain
A study testing Ischemic compression, Low-level laser therapy and Standardized exercise program in people with Chronic Pelvic Pain Syndrome and Myofascial Trigger Point Pain, run by Munzur University at 1 site in Turkey (Türkiye).
Trial summary
Objective: To investigate the effectiveness of ischemic compression and low-level laser therapy methods combined with exercise on the myofascial trigger points in women with Chronic Pelvic Pain and to determine which method is more effective. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Pelvic Pain Syndrome, Myofascial Trigger Point Pain
- What is being tested?
- Ischemic compression, Low-level laser therapy and Standardized exercise program
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 1 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- participants had to be between 18-50 years of age,
- had pain/discomfort in the lower abdominal and pelvic region lasting for 3 months in the last 6 months.
- Patients with MTrPs in at least two of the examined muscles (rectus abdominis, piriformis, quadratus lumborum, gluteus maximus-medius, adductor magnus, hamstring) were included in order to perform statistical analysis.
Who cannot join
- anticoagulation or bleeding disorders,
- neuropathy, central nervous system disorders,
- advanced psychiatric disorders,
- significant pelvic pathology or abnormality, severe prolapse, pregnancy,
- to have undergone major surgery and pelvic surgery with general anesthesia in the last 3 months,
- to have received treatment including electrotherapy and manual therapy for the pelvic region in the last 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Trigger Point Treatment in Chronic Pelvic Pain; A Pilot Randomized Controlled Trail
Objective: To investigate the effectiveness of ischemic compression and low-level laser therapy methods combined with exercise on the myofascial trigger points in women with Chronic Pelvic Pain and to determine which method is more effective.
Methods: It was a parallel designed, single-blind pilot randomized clinical trial. Patients were enrolled in the Department of Obstetrics and Gynecology (at Istanbul University-Cerrahpasa). The patients were diagnosed by a gynecologist (F.G.U and C. Y.), referred to the clinical laboratory of physiotherapy and rehabilitation to participate (by physiotherapists K.S. and E.K.M.) in the trial from September 2017 to June 2019. Twenty-eight women patients with Chronic Pelvic Pain were included into the trial. Patients were randomized into two groups. Group 1 received ischemic compression and Group 2 received low-level laser therapy twice a week for 6 weeks. Both groups received the same standard exercise program. Pain, range of motion, pelvic floor symptom severity, quality of life, satisfaction, anxiety, and depression were assessed after 6 weeks and 1-year follow up.
Read the detailed description
Chronic pelvic pain (CPP) is chronic or persistent pain perceived in structures related to the pelvic region. CPP prevalence range between 5.7 % and 26.6 % in women. CPP is associated with symptoms suggestive of the lower urinary tract, sexual, bowel, pelvic floor, or gynecological dysfunction. It is often associated with negative emotional consequences and impaired quality of life (QoL) Analgesics, hormone therapy, physiotherapy, psychological treatment, and surgical methods are widely used in the treatment of CPP. Medications provide pain and visceral management, surgery provides correction of structure, but physiotherapy approachs provides functional restoration. Musculoskeletal pelvic pain is commonly originated myofascial, musculoskeletal, neuromuscular structures. CPP patients have myofascial trigger points (MTrPs) located in the lower back, abdominal wall, and pelvic girdle, which may be the primary source of pain. These MTrPs are usually located in levator ani, obturator internus, piriformis, gluteal muscles, quadratus lumborum and abdominal wall muscles. The MTrPs are hyperirritable spots within a taut band, activated by repeated or chronic muscular overload.
Ischemic compression (IC), in the other words trigger point compression, is an effective method in the treatment of MTrPs in many musculoskeletal problems. IC changes the circulatory perfusion of skin and is especially valuable in muscles that are not suitable for stretch. It is less common to use pelvic floor rehabilitation, urological CPP, interstitial cystitis and painful bladder syndrome and CPP yet. Low-level laser therapy (LLLT) reduces pain in MTrPs lead to musculoskeletal system disorders. LLLT increases oxygen supply to hypoxic cells in MTrPs areas by regulating microcirculation as well as it has analgesic, biostimulation, and wound healing effects . In the literature, it is seen that IC and LLLT are effective on MTrPs, and IC is used in pelvic pain in a few studies. But the use of LLLT in pelvic pain has not been found. It is a known fact that exercise is the basis for these MTrPs treatments. In light of this knowledge, investigetors hypothesized that both IC and LLLT combined with exercise would be an effective methods in the management of CPP.
- Being tested
- Ischemic compression, Low-level laser therapy, Standardized exercise program
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ischemic compressionOther
IC was applied over the detected MTrPs and the participant was asked to describe the pressure and pain she felt . It was started with moderate tolerable pressure (7/10) and then severity was increased. The color of the thumb pulp was observed to control the pressure. The pressure was continued for 90 sec. The patient's pain sensation continued to be questioned and the pressure was controlled to a level at "comfortable pain"
Low-level laser therapyDevice
LLLT was applied for 90 sec at each MTrPs with a frequency of 2000 Hz (3 J) using a GaAs diode laser instrument (Roland Serie Elettronica Pagani, wavelength 904 nm, the frequency range of 5-7000 Hz and maximum peak power of 27, 50 or 2764 W) . The laser probe was held perpendicular to the MTrPs in skin contact without pressure.
Standardized exercise programBehavioural
The standardized exercise program included stretching and pilates exercises for core stabilization. All exercises were supervised by the same physiotherapist whom certificated by The Australian Physiotherapy and Pilates Institute (APPI). Pilates exercises were selected from APPI's mat-work exercises and performed in accordance with APPI principles. In addition, patients performed stretching exercises for 5 days a week and pilates exercises for 3 days a week at home.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic compression (IC) group | Experimental | Ischemic compression group received ischemic compression and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes. Receives: Other: Ischemic compression; Behavioral: Standardized exercise program |
| Low-level laser therapy (LLLT) group | Experimental | Low-level laser therapy group received Low-level laser therapy and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes. Receives: Device: Low-level laser therapy; Behavioral: Standardized exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale (VAS)
Pain intensity was assessed using the VAS, in which the patients were asked to indicate their perceived pain during rest, activity and at night (0-10 numeric pain rating scale, with 0 as no pain and 10 as worst imaginable pain) .
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Pressure Pain Threshold (PPT)
Handheld pressure algometer (Commander Algometer, J Tech Medical Industries, Midvale, Utah; maximum output=111.6N/cm2) was used to measure PPT on the MTrPs determined by clinical examination. Investigetors asked the subjects to say "stop" as soon as a discernible sensation of pain was felt. When the subject lying on loose position, a 1-cm2 algometer probe was placed perpendicularly on the MTrPs, and the pressure was increased gradually (1 lb/s). First painful threshold was recorded, mean value of two measurements, with 3 minutes interval, was used for analysis .
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Secondary outcomes (6)
Range of Motion (ROM)
Lumbar spine active ROM from full extension to full flexion, and hip active ROM on flexion, extension and mediolateral rotation was measured using a digital goniometer (Baseline Evaluation Instrument®, Fabrication Enterprises, Inc.). Average of 3 repetitions was recorded for analysis.
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
The Pelvic Floor Bother Questionnaire (PFBQ)
The Pelvic Floor Bother Questionnaire (PFBQ) was used to identify the presence and degree of bother related to common pelvic floor problems. It had excellent test-retest reliability (0.998, p<0.0001).
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Urogenital Distress Inventory (UDI-6)
Urogenital Distress Inventory (UDI-6) was used to assess urinary symptoms related QoL. It consists of 6 questions covering three domains: stress urinary incontinence, detrusor overactivity, bladder outlet obstruction. It had high internal consistency (Cronbach's alpha: 0.74) and test-retest reliability (Spearman's rho:0.99, p<0.001).
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Short Form Health Survey-36 (SF-36)
Short Form Health Survey-36 (SF-36) was used to assess the general QoL. It consists of 36 items, 8 sub-scales; physical and social functioning, role limitations due to physical health and emotional problems, emotional well-being, pain, energy-fatigue, general health status. It has recently been shown to be highly reliable (Cronbach alpha value of the subscales varied in the range 0.792-0.992) in chronic pain.
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
The Hospital Anxiety and Depression Scale (HADS)
The Hospital Anxiety and Depression Scale (HADS) was used to identify the anxiety disorders and depression among patients. It has anxiety and depression subscale, both containing seven items. It had high internal consistency (Cronbach's alpha coefficient: 0.8525 for anxiety subscale and 0.7784 for depression subscale)
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Patient Global Impression of Improvement (PGII)
Patient Global Impression of Improvement (PGII) used to assess patient satisfaction. It consists of 7-point question (1=very much better, 7=very much worse) asking the patient's level of recovery after treatment. PGII have a significant correlation with incontinence episode frequency, stress pad test, and incontinence-related quality of life .
Measured: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Sep 2017
- Primary completion1 Jun 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pelvic Pain SyndromeStudies 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
- Randomized parallel designed two arm clinical study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Munzur University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Kubra Sagır, Munzur University
- Investigators
- Kübra Sağır Ataş, MSC, Principal investigator, Munzur University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546203
- Sponsor's protocol ID
- Kubra_2018
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Trigger Point Treatment in Chronic Pelvic Pain; A Pilot Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05546203
- Acronym / sponsor ID
- Kubra_2018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Munzur UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 19 Sep 2022 (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.
Objective: To investigate the effectiveness of ischemic compression and low-level laser therapy methods combined with exercise on the myofascial trigger points in women with Chronic Pelvic Pain and to determine which method is more effective.
Methods: It was a parallel designed, single-blind pilot randomized clinical trial. Patients were enrolled in the Department of Obstetrics and Gynecology (at Istanbul University-Cerrahpasa). The patients were diagnosed by a gynecologist (F.G.U and C. Y.), referred to the clinical laboratory of physiotherapy and rehabilitation to participate (by physiotherapists K.S. and E.K.M.) in the trial from September 2017 to June 2019. Twenty-eight women patients with Chronic Pelvic Pain were included into the trial. Patients were randomized into two groups. Group 1 received ischemic compression and Group 2 received low-level laser therapy twice a week for 6 weeks. Both groups received the same standard exercise program. Pain, range of motion, pelvic floor symptom severity, quality of life, satisfaction, anxiety, and depression were assessed after 6 weeks and 1-year follow up.
Detailed description
Chronic pelvic pain (CPP) is chronic or persistent pain perceived in structures related to the pelvic region. CPP prevalence range between 5.7 % and 26.6 % in women. CPP is associated with symptoms suggestive of the lower urinary tract, sexual, bowel, pelvic floor, or gynecological dysfunction. It is often associated with negative emotional consequences and impaired quality of life (QoL) Analgesics, hormone therapy, physiotherapy, psychological treatment, and surgical methods are widely used in the treatment of CPP. Medications provide pain and visceral management, surgery provides correction of structure, but physiotherapy approachs provides functional restoration. Musculoskeletal pelvic pain is commonly originated myofascial, musculoskeletal, neuromuscular structures. CPP patients have myofascial trigger points (MTrPs) located in the lower back, abdominal wall, and pelvic girdle, which may be the primary source of pain. These MTrPs are usually located in levator ani, obturator internus, piriformis, gluteal muscles, quadratus lumborum and abdominal wall muscles. The MTrPs are hyperirritable spots within a taut band, activated by repeated or chronic muscular overload.
Ischemic compression (IC), in the other words trigger point compression, is an effective method in the treatment of MTrPs in many musculoskeletal problems. IC changes the circulatory perfusion of skin and is especially valuable in muscles that are not suitable for stretch. It is less common to use pelvic floor rehabilitation, urological CPP, interstitial cystitis and painful bladder syndrome and CPP yet. Low-level laser therapy (LLLT) reduces pain in MTrPs lead to musculoskeletal system disorders. LLLT increases oxygen supply to hypoxic cells in MTrPs areas by regulating microcirculation as well as it has analgesic, biostimulation, and wound healing effects . In the literature, it is seen that IC and LLLT are effective on MTrPs, and IC is used in pelvic pain in a few studies. But the use of LLLT in pelvic pain has not been found. It is a known fact that exercise is the basis for these MTrPs treatments. In light of this knowledge, investigetors hypothesized that both IC and LLLT combined with exercise would be an effective methods in the management of CPP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized parallel designed two arm clinical study
| Arm | Type | Receives |
|---|---|---|
| Ischemic compression (IC) group | Experimental | Other: Ischemic compression, Behavioral: Standardized exercise programIschemic compression group received ischemic compression and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes. |
| Low-level laser therapy (LLLT) group | Experimental | Device: Low-level laser therapy, Behavioral: Standardized exercise programLow-level laser therapy group received Low-level laser therapy and standardized exercise program twice a week for 6 weeks. Each session takes 50 minutes. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- participants had to be between 18-50 years of age,
- had pain/discomfort in the lower abdominal and pelvic region lasting for 3 months in the last 6 months.
- Patients with MTrPs in at least two of the examined muscles (rectus abdominis, piriformis, quadratus lumborum, gluteus maximus-medius, adductor magnus, hamstring) were included in order to perform statistical analysis.
Key exclusion criteria (6 listed)
- anticoagulation or bleeding disorders,
- neuropathy, central nervous system disorders,
- advanced psychiatric disorders,
- significant pelvic pathology or abnormality, severe prolapse, pregnancy,
- to have undergone major surgery and pelvic surgery with general anesthesia in the last 3 months,
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 |
|---|---|---|
| Ischemic compressionIC was applied over the detected MTrPs and the participant was asked to describe the pressure and pain she felt . It was started with moderate tolerable pressure (7/10) and then severity was increased. The color of the thumb pulp was observed to control the pressure. The pressure was continued for 90 sec. The patient's pain sensation continued to be questioned and the pressure was controlled to a level at "comfortable pain" | Other | Ischemic compression (IC) group |
| Low-level laser therapyLLLT was applied for 90 sec at each MTrPs with a frequency of 2000 Hz (3 J) using a GaAs diode laser instrument (Roland Serie Elettronica Pagani, wavelength 904 nm, the frequency range of 5-7000 Hz and maximum peak power of 27, 50 or 2764 W) . The laser probe was held perpendicular to the MTrPs in skin contact without pressure. | Device | Low-level laser therapy (LLLT) group |
| Standardized exercise programThe standardized exercise program included stretching and pilates exercises for core stabilization. All exercises were supervised by the same physiotherapist whom certificated by The Australian Physiotherapy and Pilates Institute (APPI). Pilates exercises were selected from APPI's mat-work exercises and performed in accordance with APPI principles. In addition, patients performed stretching exercises for 5 days a week and pilates exercises for 3 days a week at home. | Behavioural | Ischemic compression (IC) group, Low-level laser therapy (LLLT) group |
Primary outcome
Visual analog scale (VAS)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Pain intensity was assessed using the VAS, in which the patients were asked to indicate their perceived pain during rest, activity and at night (0-10 numeric pain rating scale, with 0 as no pain and 10 as worst imaginable pain) .
Pressure Pain Threshold (PPT)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Handheld pressure algometer (Commander Algometer, J Tech Medical Industries, Midvale, Utah; maximum output=111.6N/cm2) was used to measure PPT on the MTrPs determined by clinical examination. Investigetors asked the subjects to say "stop" as soon as a discernible sensation of pain was felt. When the subject lying on loose position, a 1-cm2 algometer probe was placed perpendicularly on the MTrPs, and the pressure was increased gradually (1 lb/s). First painful threshold was recorded, mean value of two measurements, with 3 minutes interval, was used for analysis .
6 secondary outcomes
Range of Motion (ROM)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
The Pelvic Floor Bother Questionnaire (PFBQ)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Urogenital Distress Inventory (UDI-6)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Short Form Health Survey-36 (SF-36)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
The Hospital Anxiety and Depression Scale (HADS)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
Patient Global Impression of Improvement (PGII)
Time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up
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 22 Sep 2022.
- Laser therapy and needling in myofascial trigger point deactivationLink provided by the sponsor.
- Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Chronic Pelvic Pain Syndrome
Not yet recruiting
Focused Ultrasound Neuromodulation for Chronic Pain
Chronic Pain, Sickle Cell Disease
Not yet recruiting
Pregabalin for Chronic Pelvic Pain in Women
Chronic Pelvic Pain, Chronic Pelvic Pain Syndrome
Recruiting
Trial of Ovarian Vein and Pelvic Vein Embolization in Women With Chronic Pelvic Pain and Pelvic Varices
Chronic Pelvic Pain Syndrome, Pelvic Pain
Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
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.
Kübra Sağır Ataş, MSC principal investigator
Munzur 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 Ischemic compression, Low-level laser therapy and Standardized exercise program in people with Chronic Pelvic Pain Syndrome and Myofascial Trigger Point Pain, run by Munzur University at 1 site in Turkey (Türkiye).
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 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 22 Sep 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 Turkey (Türkiye). 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?
Visual analog scale (VAS) (time frame: 1- a day before the treatment program 2- at the time of discharge (end of the 6 weeks program) 3- at the 1 year follow-up). The study lists 2 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 22 Sep 2022.