TenosynovitisPhase 4NCT03704584
Corticosteroid(CS) + Lido or Corticosteroid(CS) Alone
A Phase 4 study testing Treatment Group: Corticosteroid injection and Treatment Group: Lidocaine in people with Tenosynovitis, run by Emory University at 3 sites in United States.
Trial summary
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Tenosynovitis
- What is being tested?
- Treatment Group: Corticosteroid injection and Treatment Group: Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 May 2019to 14 Jan 2020
- Phase
- Phase 4
- 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 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult clinical patients of Emory upper extremity surgeons undergoing injection for treatment of the following who are willing to participate in the study will be included in the study: Tenosynovitis of the upper extremity, including but not limited to, the shoulder, biceps, elbow, wrist, thumb, carpometacarpal, midcarpal, elbow, and small joints of the hand.
- Between the ages of 18 years and 95 years.
- For trigger finger: patients with a diagnosis of stenosing tenosynovitis based on a history of triggering and the presence of tenderness over the A1 pulley upon clinical examination. All patients, based on the Quinnell grading of trigger finger will be included.
Who cannot join
- Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study.
- Allergies to glucocorticoids, current daily use of glucocorticoids or strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, and meperidine), severe diabetic neuropathy of the hand influencing pain perception, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory Clinic A, Clifton Road Clinic
Atlanta, Georgia, 30322
12 Executive Park Drive
Atlanta, Georgia, 30329
Emory Healthcare Orthopaedics and Spine Center
Atlanta, Georgia, 30329
About this study
Official title: Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that are often treated with a combination of these injectates.
Read the detailed description
A tendon is a type of tissue that connects your muscles to your bones. These tissues help control actions such as running, jumping, grasping, and lifting. Without tendons it would be difficult to control the movement of your body. A protective layer known as synovium covers tendons. This sheath produces fluid, which keeps the tendon lubricated and moving properly. Inflammation or swelling of the sheath is known as tendon sheath inflammation or tenosynovitis. This condition is often treated with an injection into or around the sheath. This injection often consists of a corticosteroid with or without lidocaine. Corticosteroid(CS) are drugs that decrease inflammation and are given for a number of orthopaedic conditions to decrease symptoms of the underlying disease. Lidocaine is also a drug that blocks the pain response, although it only blocks it momentarily. The study aims to determine if corticosteroid injection alone is as effective as corticosteroid combined with lidocaine for the relief of tenosynovitis of the upper extremity.
The study plans to enroll 1000 pts with tendinopathies of upper extremities and nerve entrapments and will be followed up in clinic 2 weeks and 6 weeks after the injection. During the clinic visits the Visual Analog Scale for pain (VAS-pain), range of motion (ROM), strength, and patient reported outcome data will be collected and any complications will be noted. Patients will also utilize a pain journal to track VAS-pain over the first 7 post-injection days.
- Conditions
- Tenosynovitis
- Being tested
- Treatment Group: Corticosteroid injection, Control Group (corticosteroid alone), Treatment Group: Lidocaine
- Keywords
- orthopedic disorders, corticosteroids(CS), Lidocaine, Injections
- Medical subject headings
- Tenosynovitis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Group: Corticosteroid injectionDrug
Also called depo-medrol, kenalog
Subjects will receive a corticosteroid injection that is 40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone.
Control Group (corticosteroid alone)Drug
Also called Methylprednisolone acetate injectable suspension
Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
Treatment Group: LidocaineDrug
Also called Xylocaine
Subjects will receive an injection of lidocaine (1% lidocaine HCl).
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group (corticosteroid injection plus lidocaine) | Active comparator | Treatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition Receives: Drug: Treatment Group: Corticosteroid injection; Drug: Treatment Group: Lidocaine |
| Control Group (corticosteroid alone) | Other | Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition Receives: Drug: Control Group (corticosteroid alone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.
Measured: Pre injection, Post injection day, 2 weeks and at 6 weeks
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented.
Measured: Post injection day (1-7), 2 weeks and at 6 weeks post intervention
Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.
Measured: 2 weeks and at 6 weeks post intervention
Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100).
Measured: 2 weeks and at 6 weeks post intervention
American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
Measured: 2 weeks and at 6 weeks post intervention
Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Measured: 2 weeks and at 6 weeks post intervention
Number of Patients With Subsequent Reinjection and Surgical Operation
The number of patients with subsequent reinjection and surgical operation was collected during follow up.
Measured: End of follow up (6 weeks post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start14 May 2019
- Primary completion14 Jan 2020
- Study completion14 Jan 2020
Why it stopped: Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.
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.
- Other trials for TenosynovitisStudies of the same condition, open and under way.
- More trials run by Emory 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, unblinded controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles A Daly, Emory University
- Investigators
- Charles Daly, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704584
- Sponsor's protocol ID
- IRB00104900
- Status last verified
- Sep 2022
- First submitted
- 10 Oct 2018
- Last updated
- 12 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corticosteroid(CS) Injections for the Treatment of Common Upper Extremity Pathologies, With or Without Lidocaine
- ClinicalTrials.gov ID
- NCT03704584
- Acronym / sponsor ID
- IRB00104900
- Conditions
- Tenosynovitis
- Keywords
- orthopedic disorders, corticosteroids(CS), Lidocaine, Injections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment and study activities were initially suspended due to COVID-19. The investigator has also left Emory and the study will not resume.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- 14 Jan 2020 (actual)
- Study completion
- 14 Jan 2020 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 12 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial is a randomized control trial to compare the efficacy of a combined lidocaine and corticosteroid (CS) injection versus a corticosteroid injection (CS) alone on pain, range of motion, and patient reported outcomes for the treatment of common upper extremity tendinopathies and nerve entrapments that are often treated with a combination of these injectates.
Detailed description
A tendon is a type of tissue that connects your muscles to your bones. These tissues help control actions such as running, jumping, grasping, and lifting. Without tendons it would be difficult to control the movement of your body. A protective layer known as synovium covers tendons. This sheath produces fluid, which keeps the tendon lubricated and moving properly. Inflammation or swelling of the sheath is known as tendon sheath inflammation or tenosynovitis. This condition is often treated with an injection into or around the sheath. This injection often consists of a corticosteroid with or without lidocaine. Corticosteroid(CS) are drugs that decrease inflammation and are given for a number of orthopaedic conditions to decrease symptoms of the underlying disease. Lidocaine is also a drug that blocks the pain response, although it only blocks it momentarily. The study aims to determine if corticosteroid injection alone is as effective as corticosteroid combined with lidocaine for the relief of tenosynovitis of the upper extremity.
The study plans to enroll 1000 pts with tendinopathies of upper extremities and nerve entrapments and will be followed up in clinic 2 weeks and 6 weeks after the injection. During the clinic visits the Visual Analog Scale for pain (VAS-pain), range of motion (ROM), strength, and patient reported outcome data will be collected and any complications will be noted. Patients will also utilize a pain journal to track VAS-pain over the first 7 post-injection days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, unblinded controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment Group (corticosteroid injection plus lidocaine) | Active comparator | Drug: Treatment Group: Corticosteroid injection, Drug: Treatment Group: LidocaineTreatment Group (corticosteroid injection plus lidocaine) subjects will receive (Methylprednisolone acetate injectable suspension and Lidocaine HCl) for their upper extremity condition |
| Control Group (corticosteroid alone) | Other | Drug: Control Group (corticosteroid alone)Control Group (corticosteroid alone) subjects will receive (Methylprednisolone acetate injectable suspension) for their upper extremity condition |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All adult clinical patients of Emory upper extremity surgeons undergoing injection for treatment of the following who are willing to participate in the study will be included in the study: Tenosynovitis of the upper extremity, including but not limited to, the shoulder, biceps, elbow, wrist, thumb, carpometacarpal, midcarpal, elbow, and small joints of the hand.
- Between the ages of 18 years and 95 years.
- For trigger finger: patients with a diagnosis of stenosing tenosynovitis based on a history of triggering and the presence of tenderness over the A1 pulley upon clinical examination. All patients, based on the Quinnell grading of trigger finger will be included.
Key exclusion criteria (3 listed)
- Patients who are minors, vulnerable subjects, or who are not willing to consent to participate in the study.
- Allergies to glucocorticoids, current daily use of glucocorticoids or strong opioids (morphine, fentanyl, hydromorphone, ketobemidone, methadone, nicomorphine, oxycodone, and meperidine), severe diabetic neuropathy of the hand influencing pain perception, rheumatoid arthritis, and neurological or psychiatric diseases, potentially influencing pain perception.
- Subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.
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 |
|---|---|---|
| Treatment Group: Corticosteroid injectionAlso: depo-medrol, kenalogSubjects will receive a corticosteroid injection that is 40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone. | Drug | Treatment Group (corticosteroid injection plus lidocaine) |
| Control Group (corticosteroid alone)Also: Methylprednisolone acetate injectable suspensionControl Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) . | Drug | Control Group (corticosteroid alone) |
| Treatment Group: LidocaineAlso: XylocaineSubjects will receive an injection of lidocaine (1% lidocaine HCl). | Drug | Treatment Group (corticosteroid injection plus lidocaine) |
Primary outcome
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time frame: Pre injection, Post injection day, 2 weeks and at 6 weeks
Pain will be assessed with a 10-point scale (0: no pain, 10: highest amount of pain) of anticipated pain and anxiety before injection and a 10-point pain scale of the pain of the needle, medication, overall pain and anxiety after the injection was administered to the participants.
Visual Analog Pain Scale (VAS-pain) Daily Until Post-injection Day 7
Time frame: Post injection day (1-7), 2 weeks and at 6 weeks post intervention
Participants were instructed to log their pain twice daily (morning and night) using a VAS pain scale of 0-10 (0: no pain, 10: highest amount of pain) for the first 7 days after injection. Participants were instructed to bring that pain journal to their 2-week visit. Average daily scores are presented.
Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time frame: 2 weeks and at 6 weeks post intervention
The domains explored by the Quick DASH are: (1) physical arm, shoulder or hand activity problems (6 items); (2) severity of pain and tingling (2 items); (3) social activities, work, and sleep (3 items). Each item has five response options, ranging from 1, ''no difficulty or no symptom,'' to 5, ''unable to perform activity or very severe symptom.'' If at least 10 of the 11 items are completed, a score ranging from 0 (no disability) to 100 (most severe disability) can be calculated [(sum of n responses/n) - 1] x 25.the effect size and the percentage of patients reaching Minimal Clinical Important Improvement was determined.
Patient-Rated Wrist Evaluation (PRWE) Score at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time frame: 2 weeks and at 6 weeks post intervention
The Patient-Related Wrist Evaluation is a score for the measurement of pain and function after injury to the wrist. The PRWE is a 15-item questionnaire that allows patients to rate their levels of wrist pain and disability from 0 to 10, and consists of 2 subscales Pain subscale: contains 5 items each of which is further rated from 1-10. The maximum score in this section is 50 and minimum 0 Function subscale: contains total 10 items which are further divided into 2 sections i.e specific activities (having 6 items) and usual activities (having 4 items). The maximum score in this section is 50 and minimum 0. Total Score = Sum of pain+ function scores (Best Score = 0, Worst Score = 100).
American Shoulder and Elbow Surgeons Shoulder Score (ASES) at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time frame: 2 weeks and at 6 weeks post intervention
The American Shoulder and Elbow Surgeons Shoulder Score (ASES) is a mixed outcome reporting measure, applicable for use in all patients with shoulder pathology for the assessment of shoulder function. The ASES questionnaire is composed of 17 questions. The questions focus on joint pain, instability, and activities of daily living. It is a 100 point scale (Pain scale= 50 points, 10 activities of daily living = 50 points).Score range: Pain subscale 0-50 ASES points; function/disability subscale 0-50 ASES points. Total score 0-100 ASES points (0 = worse pain and functional loss/disability)
Short Form Health Survey (SF-12) Scores at Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group
Time frame: 2 weeks and at 6 weeks post intervention
The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. SF-12 is a standardized self-report questionnaire that assesses mental and physical functioning. The SF-12 consists of 12 items with a Likert-type response format that measures quality of life with a Physical Component Summary (PCS) and Mental Component Summary (MCS). Subscales associated with the PCS include physical functioning, role limitations due to physical problems, bodily pain, and general health perceptions. Subscales associated with the MCS include vitality (energy and fatigue), social functioning, role limitations due to emotional problems, and mental health. A scoring algorithm is used to generate a total score for each component ranging from 0 to 100. Low values represent a poor health state while high values represent a good health state.
Number of Patients With Subsequent Reinjection and Surgical Operation
Time frame: End of follow up (6 weeks post intervention)
The number of patients with subsequent reinjection and surgical operation was collected during follow up.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Charles Daly, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Treatment Group: Corticosteroid injection and Treatment Group: Lidocaine in people with Tenosynovitis, run by Emory University at 3 sites 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2022). 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?
10 Point Likert Scale of Pain Scores Before the Injection and After the Injection and During Follow up in the Corticosteroid Plus Lidocaine Group as Compared to the Corticosteroid Alone Group (time frame: Pre injection, Post injection day, 2 weeks and at 6 weeks). The study lists 7 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 12 Oct 2022.