Subacromial Impingement SyndromeTENSICNCT02110030
Effectiveness of Two Electrotherapy Techniques to Treat Subacromial Impingement Syndrome
A study testing Transcutaneous nerve stimulation and Interferential Currents in people with Subacromial Impingement Syndrome, run by Camilo Jose Cela University at 1 site in Spain.
Trial summary
Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality and to reduce perceived pain in patients with subacromial impingement syndrome (SIS). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Transcutaneous nerve stimulation and Interferential Currents
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2014to Jun 2014
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subjects for this study were recruited from a waiting list from patients with acute shoulder pain at the Almendrales Medicine and Physiotherapy Center (Madrid, Spain).
- To be included in the list they had to be older than 18 years and have had unilateral shoulder pain for more than 1 month.
- Potential participants were then examined by an independent specialist and the diagnosis of SIS was made according to the Hawkins and Jobe tests.
- The use of X-ray, ultrasonography and magnetic resonance imaging permitted objective diagnoses of shoulder impingement syndrome and the exclusion of patients with other shoulder pathologies.
Who cannot join
- The following participants were excluded from the investigation: individuals with rotator cuff tears or calcification; individuals with the presence of acute trauma; patients who were receiving treatment for their shoulder pain with another method; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality and to reduce perceived pain in patients with subacromial impingement syndrome (SIS). Design: Thirty-six patients with unilateral shoulder pain and diagnosed as having SIS were randomly assigned into two groups: TENS (n=18; 51±7 years) and IC (n=18; 47±6 years). Patients in both groups received fifteen 30-min sessions of the assigned treatment for a period of 3 weeks. Before and after the treatment, shoulder pain was measured using a 100-mm visual analog scale and shoulder functionality was measured using the Constant-Murley scale.
Read the detailed description
Subjects
The subjects for this study were recruited from a waiting list from patients with acute shoulder pain at the Almendrales Medicine and Physiotherapy Center (Madrid, Spain). To be included in the list they had to be older than 18 years and have had unilateral shoulder pain for more than 1 month. Potential participants were then examined by an independent specialist and the diagnosis of SIS was made according to the Hawkins and Jobe tests. The use of X-ray, ultrasonography and magnetic resonance imaging permitted objective diagnoses of SIS and the exclusion of patients with other shoulder pathologies. With these inclusion criteria, a total of 63 patients were recruited for the experiment. The following participants were excluded from the investigation: individuals with rotator cuff tears or calcification; individuals with the presence of acute trauma; patients who were receiving treatment for their SIS with another method; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy. Ethical approval for this experiment was previously obtained by the local Institutional Review and all participants signed an informed consent prior to enrolling in the investigation.
Treatment groups
The experimental design was a randomized and double-blind clinical trial. After preliminary examination, the patients were randomly assigned into two groups: transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC). A set of sealed and sequentially numbered opaque envelopes was used for group assignment. The study was double-blind because the examiner had no contact with the patient during the duration of the treatment and patients were not informed about the electrotherapy technique they received during the investigation.
Intervention
For both experimental groups, the treatments were applied over a period of 3 weeks, including a total of 15 sessions (approximately 5 sessions per week). In each session, the electrical stimulation technique was administered for 30 minutes while the subjects were comfortable seated in an adjustable chair. The group with TENS received electrical stimulation (Endomed 182, Enraf-nonius, Germany) at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). The current intensity was set 3 times during each session according to each patient's sensitivity. Current was strong but it did not exceed the threshold of pain. The group with IC received a base frequency of 4000 Hz (Endomed 182, Enraf-nonius, Germany) with an amplitude-modulated frequency (AMF) and slope of 1/1 in tetrapolar mode, as previously indicated. For IC, the same number and type of surface electrodes (5x5 cm Prim-Trode, Spain) were placed onto the anterior and posterior deltoid, supraspinatus fossa and "V" deltoid. Similarly, the intensity of the current was set 3 times per session and the stimulation was strong but comfortable (without exceeding the threshold of pain). The treatments were administered by an experienced physiotherapist blinded to the aim of this investigation.
Outcome measurements
Shoulder pain was evaluated before and the day after the end of treatments by using a 100 mm visual analog pain scale. Functional status in the shoulder joint was evaluated two days before, after 8 sessions of treatment and the day after the end of the treatment by using the Constant-Murley scale. This scale is valid to assess the overall functionality of a normal, a diseased or a treated shoulder. In this scale, 35% of the total value was allocated from subjective assessments of pain (20%) and self-evaluation of activities of daily living (15%; including shoulder pain during sleeping, dysfunction during free time or sports and dysfunction during working activities). The remaining 65% of the total value came from objective measures of range of movement and shoulder strength. Within the objective evaluation, the range of motion during internal and external rotation, arm flexion and lateral elevation (all measured by using an inclinometer) amounted to 10% each of the total score. Strength was measured using the muscular balance system by Daniels30 and counted for 25% of the total score. Thus, a young and healthy patient can have a maximal punctuation of 100 points. The pre-to-post treatment shoulder evaluation was performed by the same independent experimenter using the same instruments. This experimenter was blinded to the treatment assigned to each participant.
Statistical analysis
All the data were analyzed using SPSS v.20 statistical package. Descriptive statistics were calculated for each group (mean and standard deviation). Normality was tested with the Shapiro-Wilk test. All the variables presented a normal distribution in this test (P > 0.05). Baseline characteristics were compared using the analysis of variance (ANOVA) for measuring independent data. Pre-to-post treatment data and the comparison between groups were performed by using two-way ANOVA (group x time). After a significant F test, differences between means were identified using Tukey's HSD post hoc procedure. The level of significance was established at P < 0.05.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Transcutaneous nerve stimulation, Interferential Currents
- Keywords
- Transcutaneous electrical nerve stimulation (TENS), Ultrasound, Interferential current therapy, Rehabilitation, Shoulder pain
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous nerve stimulationDevice
Also called TENS
The group with TENS received electrical stimulation (Endomed 182, Enraf-nonius, Germany) at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). The current intensity was set 3 times during each session according to each patient's sensitivity. Current was strong but it did not exceed the threshold of pain.
Interferential CurrentsDevice
Also called IC
The group with IC received a base frequency of 4000 Hz (Endomed 182, Enraf-nonius, Germany) with an amplitude-modulated frequency (AMF) and slope of 1/1 in tetrapolar mode, as previously indicated. For IC, the same number and type of surface electrodes (5x5 cm Prim-Trode, Spain) were placed onto the anterior and posterior deltoid, supraspinatus fossa and "V" deltoid. Similarly, the intensity of the current was set 3 times per session and the stimulation was strong but comfortable (without exceeding the threshold of pain).
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous nerve stimulation | Experimental | The group with transcutaneous nerve stimulation (TENS) received electrical stimulation for 15 sessions at a frequency of 80 Hz and with a pulse width of 150 ns.
The group with TENS received electrical stimulation by using an approved electrotherapy device (Endomed 182, Enraf-nonius, Germany). The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). Receives: Device: Transcutaneous nerve stimulation |
| Interferential Currents | Active comparator | The group with Interferential Currents (IC) received a base frequency of 4000 Hz by using the same approved electrotherapy device than the TENS group (Endomed 182, Enraf-nonius, Germany). Receives: Device: Interferential Currents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder functionality
Functional status in the shoulder joint was evaluated by using the Constant-Murley scale. This scale is valid to assess the overall functionality of a normal, a diseased or a treated shoulder. In this scale, 35% of the total value was allocated from subjective assessments of pain (20%) and self-evaluation of activities of daily living (15%; including shoulder pain during sleeping, dysfunction during free time or sports and dysfunction during working activities). The remaining 65% of the total value came from objective measures of range of movement and shoulder strength.
Shoulder functionality was measured by using a 0-100 point scale.
The pre-to-post treatment shoulder evaluation was performed by the same independent experimenter using the same instruments.
Measured: Before and after the 3 weeks of electrotherpy treatment
Shoulder pain
Shoulder pain was evaluated before and the day after the end of treatments by using a 100 mm visual analog pain scale.
Measured: Before and after the 3 weeks of electrotherpy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Collaborators
- Public Health Service of Madrid
- Responsible party
- Sponsor
- Investigators
- Juan Del Coso, PhD, Principal investigator, Camilo Jose Cela University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110030
- Sponsor's protocol ID
- UCJC-13
- Acronym
- TENSIC
- Status last verified
- Jul 2019
- First submitted
- 4 Apr 2014
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
PubMed 18218327
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Electrotherapy Techniques to Treat Subacromial Impingement Syndrome
- ClinicalTrials.gov ID
- NCT02110030
- Acronym / sponsor ID
- TENSIC / UCJC-13
- Conditions
- Subacromial Impingement Syndrome
- Keywords
- Transcutaneous electrical nerve stimulation (TENS), Ultrasound, Interferential current therapy, Rehabilitation, Shoulder pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Collaborators
- Public Health Service of Madrid
- Study start
- Apr 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Apr 2014 (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.
Objective: The investigators aimed to compare the effectiveness of transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC) to improve shoulder functionality and to reduce perceived pain in patients with subacromial impingement syndrome (SIS). Design: Thirty-six patients with unilateral shoulder pain and diagnosed as having SIS were randomly assigned into two groups: TENS (n=18; 51±7 years) and IC (n=18; 47±6 years). Patients in both groups received fifteen 30-min sessions of the assigned treatment for a period of 3 weeks. Before and after the treatment, shoulder pain was measured using a 100-mm visual analog scale and shoulder functionality was measured using the Constant-Murley scale.
Detailed description
Subjects
The subjects for this study were recruited from a waiting list from patients with acute shoulder pain at the Almendrales Medicine and Physiotherapy Center (Madrid, Spain). To be included in the list they had to be older than 18 years and have had unilateral shoulder pain for more than 1 month. Potential participants were then examined by an independent specialist and the diagnosis of SIS was made according to the Hawkins and Jobe tests. The use of X-ray, ultrasonography and magnetic resonance imaging permitted objective diagnoses of SIS and the exclusion of patients with other shoulder pathologies. With these inclusion criteria, a total of 63 patients were recruited for the experiment. The following participants were excluded from the investigation: individuals with rotator cuff tears or calcification; individuals with the presence of acute trauma; patients who were receiving treatment for their SIS with another method; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy. Ethical approval for this experiment was previously obtained by the local Institutional Review and all participants signed an informed consent prior to enrolling in the investigation.
Treatment groups
The experimental design was a randomized and double-blind clinical trial. After preliminary examination, the patients were randomly assigned into two groups: transcutaneous electrical nerve stimulation (TENS) and interferential currents (IC). A set of sealed and sequentially numbered opaque envelopes was used for group assignment. The study was double-blind because the examiner had no contact with the patient during the duration of the treatment and patients were not informed about the electrotherapy technique they received during the investigation.
Intervention
For both experimental groups, the treatments were applied over a period of 3 weeks, including a total of 15 sessions (approximately 5 sessions per week). In each session, the electrical stimulation technique was administered for 30 minutes while the subjects were comfortable seated in an adjustable chair. The group with TENS received electrical stimulation (Endomed 182, Enraf-nonius, Germany) at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). The current intensity was set 3 times during each session according to each patient's sensitivity. Current was strong but it did not exceed the threshold of pain. The group with IC received a base frequency of 4000 Hz (Endomed 182, Enraf-nonius, Germany) with an amplitude-modulated frequency (AMF) and slope of 1/1 in tetrapolar mode, as previously indicated. For IC, the same number and type of surface electrodes (5x5 cm Prim-Trode, Spain) were placed onto the anterior and posterior deltoid, supraspinatus fossa and "V" deltoid. Similarly, the intensity of the current was set 3 times per session and the stimulation was strong but comfortable (without exceeding the threshold of pain). The treatments were administered by an experienced physiotherapist blinded to the aim of this investigation.
Outcome measurements
Shoulder pain was evaluated before and the day after the end of treatments by using a 100 mm visual analog pain scale. Functional status in the shoulder joint was evaluated two days before, after 8 sessions of treatment and the day after the end of the treatment by using the Constant-Murley scale. This scale is valid to assess the overall functionality of a normal, a diseased or a treated shoulder. In this scale, 35% of the total value was allocated from subjective assessments of pain (20%) and self-evaluation of activities of daily living (15%; including shoulder pain during sleeping, dysfunction during free time or sports and dysfunction during working activities). The remaining 65% of the total value came from objective measures of range of movement and shoulder strength. Within the objective evaluation, the range of motion during internal and external rotation, arm flexion and lateral elevation (all measured by using an inclinometer) amounted to 10% each of the total score. Strength was measured using the muscular balance system by Daniels30 and counted for 25% of the total score. Thus, a young and healthy patient can have a maximal punctuation of 100 points. The pre-to-post treatment shoulder evaluation was performed by the same independent experimenter using the same instruments. This experimenter was blinded to the treatment assigned to each participant.
Statistical analysis
All the data were analyzed using SPSS v.20 statistical package. Descriptive statistics were calculated for each group (mean and standard deviation). Normality was tested with the Shapiro-Wilk test. All the variables presented a normal distribution in this test (P > 0.05). Baseline characteristics were compared using the analysis of variance (ANOVA) for measuring independent data. Pre-to-post treatment data and the comparison between groups were performed by using two-way ANOVA (group x time). After a significant F test, differences between means were identified using Tukey's HSD post hoc procedure. The level of significance was established at P < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous nerve stimulation | Experimental | Device: Transcutaneous nerve stimulationThe group with transcutaneous nerve stimulation (TENS) received electrical stimulation for 15 sessions at a frequency of 80 Hz and with a pulse width of 150 ns. The group with TENS received electrical stimulation by using an approved electrotherapy device (Endomed 182, Enraf-nonius, Germany). The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). |
| Interferential Currents | Active comparator | Device: Interferential CurrentsThe group with Interferential Currents (IC) received a base frequency of 4000 Hz by using the same approved electrotherapy device than the TENS group (Endomed 182, Enraf-nonius, Germany). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subjects for this study were recruited from a waiting list from patients with acute shoulder pain at the Almendrales Medicine and Physiotherapy Center (Madrid, Spain).
- To be included in the list they had to be older than 18 years and have had unilateral shoulder pain for more than 1 month.
- Potential participants were then examined by an independent specialist and the diagnosis of SIS was made according to the Hawkins and Jobe tests.
- The use of X-ray, ultrasonography and magnetic resonance imaging permitted objective diagnoses of shoulder impingement syndrome and the exclusion of patients with other shoulder pathologies.
Key exclusion criteria (1 listed)
- The following participants were excluded from the investigation: individuals with rotator cuff tears or calcification; individuals with the presence of acute trauma; patients who were receiving treatment for their shoulder pain with another method; patients with previous surgery or intra-articular injections; individuals with contraindications against electrotherapy
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 |
|---|---|---|
| Transcutaneous nerve stimulationAlso: TENSThe group with TENS received electrical stimulation (Endomed 182, Enraf-nonius, Germany) at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and "V" deltoid " (channel 2). The current intensity was set 3 times during each session according to each patient's sensitivity. Current was strong but it did not exceed the threshold of pain. | Device | Transcutaneous nerve stimulation |
| Interferential CurrentsAlso: ICThe group with IC received a base frequency of 4000 Hz (Endomed 182, Enraf-nonius, Germany) with an amplitude-modulated frequency (AMF) and slope of 1/1 in tetrapolar mode, as previously indicated. For IC, the same number and type of surface electrodes (5x5 cm Prim-Trode, Spain) were placed onto the anterior and posterior deltoid, supraspinatus fossa and "V" deltoid. Similarly, the intensity of the current was set 3 times per session and the stimulation was strong but comfortable (without exceeding the threshold of pain). | Device | Interferential Currents |
Primary outcome
Shoulder functionality
Time frame: Before and after the 3 weeks of electrotherpy treatment
Functional status in the shoulder joint was evaluated by using the Constant-Murley scale. This scale is valid to assess the overall functionality of a normal, a diseased or a treated shoulder. In this scale, 35% of the total value was allocated from subjective assessments of pain (20%) and self-evaluation of activities of daily living (15%; including shoulder pain during sleeping, dysfunction during free time or sports and dysfunction during working activities). The remaining 65% of the total value came from objective measures of range of movement and shoulder strength. Shoulder functionality was measured by using a 0-100 point scale. The pre-to-post treatment shoulder evaluation was performed by the same independent experimenter using the same instruments.
Shoulder pain
Time frame: Before and after the 3 weeks of electrotherpy treatment
Shoulder pain was evaluated before and the day after the end of treatments by using a 100 mm visual analog pain scale.
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 24 Jul 2019.
- Background: PubMed 18218327Constant CR, Gerber C, Emery RJ, Sojbjerg JO, Gohlke F, Boileau P. A review of the Constant score: modifications and guidelines for its use. J Shoulder Elbow Surg. 2008 Mar-Apr;17(2):355-61. doi: 10.1016/j.jse.2007.06.022. Epub 2008 Jan 22. No abstract available.
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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.
Juan Del Coso, PhD principal investigator
Camilo Jose Cela 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 Transcutaneous nerve stimulation and Interferential Currents in people with Subacromial Impingement Syndrome, run by Camilo Jose Cela University at 1 site in Spain.
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 4 inclusion and 1 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 24 Jul 2019. 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 Spain. 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?
Shoulder functionality (time frame: Before and after the 3 weeks of electrotherpy treatment). 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?
On the ClinicalTrials.gov record for NCT02110030, which also lists 1 linked publication.
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 24 Jul 2019; AzTrials last refreshed its copy on 8 Nov 2026.