Lumbar Disc HerniationNCT04653870
Comparison of Cyriax Manipulation and Decompression in LDP
A study testing cyriax manipulation lumber and lumber decompression in people with Lumbar Disc Herniation, run by Riphah International University at 1 site in Pakistan.
Trial summary
In this study, compare the effects of Cyriax manipulation and Decompression in patient with lumber disc prolapseThis research will provide an important addition to the evidence based treatment intervention in physical therapy in the field of manipulation as there is no such research work have been done on comparative… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- cyriax manipulation lumber and lumber decompression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Feb 2020to 8 Sep 2020
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients having Lumber disc prolapse of L1-L5 and S1 (both gender)
- Patients having MRI reports of protruded disc
Who cannot join
- Inflammatory condition( systemic inflammatory disease of spine)
- Spinal diseases (other than Musculoskeletal)
- Severe radiculopathies (bilateral)
- Operated patients (spine)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Max health hospital and rehab center G8 islamabad
Islamabad, Punjab Province, 44080
About this study
Official title: Comparison the Effect of Cyriax Manipulation and Decompression in Patient With Lumber Disc Protrusion
In this study, compare the effects of Cyriax manipulation and Decompression in patient with lumber disc prolapseThis research will provide an important addition to the evidence based treatment intervention in physical therapy in the field of manipulation as there is no such research work have been done on comparative study of cyriax manipulation and decompression in lumber disc protrusion.
Read the detailed description
According to an estimate, 70 to 80% of the adult population will experience a clinically relevant episode of LBP at some time in their lives. Within the vast differential of LBP, the most common source is intervertebral degeneration leading to degenerative disc disease and LDH. The efficacy of manipulative physical therapy, physical therapy intervention and therapy by general practitioner (GP) for persistent general LBP and neck pain was investigated on 256 patients how didn't received any of the above therapy in last two years were contained in this study. Physical therapy included workout exercises, massage, and physical therapy (related to hot pack, different pain modalities like therapeutic ultrasound, shortwave diathermy, and electrotherapy). Manual therapy includes manual reduction by manipulation and mobilization of the back. Interventions received by GP is medicine related (different types of pain killer and muscles relaxant), guidance about the posture, home plan exercises and different healthy activities and proper rest. Placebo intervention included adjustable shortwave diathermy session for (10 minutes), and adjusted therapeutic ultrasound session for (10 minutes). Recovery rate in the leading complaint was increased with the group receiving manual therapy intervention (4.5) as compare to physical therapy (3.8), after a detailed one year of continuous therapy. There is a great progression seen in physical work by manual therapy. Moreover, manipulation is get going improved gradually, as compare to physiotherapy following in period of 12 months.
The first meta-analysis estimated the efficacy of SMT for LBP due to LDH with other therapies come to the result that SMT was equally effective when compare to other traditional therapies. However a past systematic review was come to the conclusion that SMT was secure and effective in relation to its costs for managing SLDD like LDH, that conclusion was quoted to promote by a very few publications.
One of the present research studies after one year of continuation showed decrease in pain and increase in recreational activities to a long period of time, an additional research work in 2016 described, a remarkable progression in sciatica after 30 days, in patients with lumber discs extrusion and sequestration, as a result of HVLA thrust.
In spite of the factor that there is only average numbers of documentation in the written work which promoted the utilization of SMT to manage LDH, it is extensively applied by therapist.
the comparison of cyriax manipulation and decompresion is an important adding to the researches in evidence based practices. there is no such work done before on comparison of both intervention.
- Conditions
- Lumbar Disc Herniation
- Being tested
- cyriax manipulation lumber, lumber decompression
- Keywords
- Herniation, Cyriax manipulation, decompression, bulge, protruded, extruded
- Medical subject headings
- Intervertebral Disc Displacement, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyriax manipulation lumberOther
In group A patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Cyriax manipulation.
Exercises (Guided low back exercises, 3-5times/day). Ankle pumping (5-10 repetition with 15-20 second hold), Quads Isometric (5-10 repetition with 15-20 second hold), Hams \& Calf stretching (5-10 repetition with 15-20 second hold), Bridging (5-10 repetition with 15-20 second hold), Prone Back extension (10 repetition) Precaution Prevent yourself from sitting low on ground, Sitting with support will be directed and be careful during driving and ascending stairs.
Cyriax Manipulation: 2-3 repetitions/session, 2 session/week Lumbar spinal manipulation Rotation Techniques Lumbar spinal manipulation Extension Techniques Lumbar spinal manipulation Antideviation Techniques total of 4 session were given. 2 session/week.
lumber decompressionOther
Group B: In group B patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Decompression Session.
Conservative therapy: Same as Group A
Lumbar spine decompression:
30 Minutes Session (generalized time for every one) . On the account of MRI description level is recommended and acknowledged by MRI the level of disc protrusion, decompression is operated. Patient is lying on table facing upward. For locking of the patient's body it was secured by pelvis and thoracic straps. One part of the decompression table is immobile other is movable. Bottom extreme part of the table is mobile.
Estimation of weight of patient is first thing to do. We calculated it by division of whole weight by 5 and that 5th segment of weight was utilized as an interventional pound for decompression. .
| Study group | Role | What they receive |
|---|---|---|
| cyriax manipulation | Experimental | cyriax manipulation have three types of classes, rotation, extension and anti-deviation, which is further divided into subclasses. On the inferior level of lumber spine L4-L5 and L5-S1rotation intervention of manipulation are capable of having striking effects of decreasing herniation. First of all we have to perform the simple 'stretch' on lumber spine, which is being the little rotation pressure applied on the body. The patient position of the body is in side lying with the effected side upward so that the outside part of the joint are separated easily on the involved side. After that, whenever it is essential by making use of femur as a rigid bar or support, this maneuver is go along with powerful rotation technique. Receives: Other: cyriax manipulation lumber |
| lumber decompresion | Experimental | Spinal decompression therapy has been developed a treatment without surgery for the prolapsed disc and deteriorative spinal disc disease one of the considerable reason for low back pain. This noninvasive interventional treatment for herniated disc and deteriorative disc diseases operated on the principle of remarkably decreasing the pressure on the disc between vertebras. Receives: Other: lumber decompression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inclinometer
Inclinometer: Dual inclinometer is used to measure dynamic ROM of lumber spine. For measuring the ROM of flexion, extension and side bending to both sides, place one inclinometer on T12 and the other on S1. Ask the patient to bend forward for flexion, bend backward for extension and sideways for side bending. Note both the readings and subtract the lower one from the above.
Measured: 2nd week
goniometer
Goniometer is used to measure SLR range before and after the treatment For the patients to perform SLR, participants lay supine on a table and are asked to actively raise their leg from the table while keeping their knee straight. Reproduction of the patient's characteristic pain or demonstration of weakness can lead to decreased range of SLR. Symptom production between the ranges of 30 degrees to 60 degrees is an indication of disc pathology.
Measured: 2nd week
Numeric pain rating scale
Numeric pain rating scale: Pain is measured by NPRS before Treatment and after treatment. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the pain where zero is no pain and 10 is maximum pain (for back and leg)
Measured: 2nd week
Oswestry disability index (ODI)
Oswestry disability index (ODI): Disability is measured by ODI before Treatment and after treatment. It is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. it consist of 10, five parts sections. at the end,s core is calculated by dividing the obtained score by total 50, and multiplied by 100. as the sexual section is missing due to ethical reason so total score is 45 instead of 50.
Measured: 2nd week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start10 Feb 2020
- Primary completion25 Aug 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Affan Iqbal, Phd*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653870
- Sponsor's protocol ID
- REC/00681 Salma Bibi
- Status last verified
- Nov 2020
- First submitted
- 28 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kocak FA, Tunc H, Tomruk Sutbeyaz S, Akkus S, Koseoglu BF, Yilmaz E. Comparison of the short-term effects of the conventional motorized traction with non-surgical spinal decompression performed with a DRX9000 device on pain, functionality, depression, and quality of life in patients with low back pain associated with lumbar disc herniation: A single-blind randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Feb 16;64(1):17-27. doi: 10.5606/tftrd.2017.154. eCollection 2018 Mar.
PubMed 31453485Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GM, Hofhuizen DM, Houben JP, Knipschild PG. Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up. BMJ. 1992 Mar 7;304(6827):601-5. doi: 10.1136/bmj.304.6827.601.
PubMed 1532760Leemann S, Peterson CK, Schmid C, Anklin B, Humphreys BK. Outcomes of acute and chronic patients with magnetic resonance imaging-confirmed symptomatic lumbar disc herniations receiving high-velocity, low-amplitude, spinal manipulative therapy: a prospective observational cohort study with one-year follow-up. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):155-63. doi: 10.1016/j.jmpt.2013.12.011. Epub 2014 Mar 11.
PubMed 24636109Ehrler M, Peterson C, Leemann S, Schmid C, Anklin B, Humphreys BK. Symptomatic, MRI Confirmed, Lumbar Disc Herniations: A Comparison of Outcomes Depending on the Type and Anatomical Axial Location of the Hernia in Patients Treated With High-Velocity, Low-Amplitude Spinal Manipulation. J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):192-9. doi: 10.1016/j.jmpt.2016.02.013. Epub 2016 Mar 28.
PubMed 27034106Oh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison the Effect of Cyriax Manipulation and Decompression in Patient With Lumber Disc Protrusion
- ClinicalTrials.gov ID
- NCT04653870
- Acronym / sponsor ID
- REC/00681 Salma Bibi
- Conditions
- Lumbar Disc Herniation
- Keywords
- Herniation, Cyriax manipulation, decompression, bulge, protruded, extruded
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 25 Aug 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 4 Dec 2020 (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.
In this study, compare the effects of Cyriax manipulation and Decompression in patient with lumber disc prolapseThis research will provide an important addition to the evidence based treatment intervention in physical therapy in the field of manipulation as there is no such research work have been done on comparative study of cyriax manipulation and decompression in lumber disc protrusion.
Detailed description
According to an estimate, 70 to 80% of the adult population will experience a clinically relevant episode of LBP at some time in their lives. Within the vast differential of LBP, the most common source is intervertebral degeneration leading to degenerative disc disease and LDH. The efficacy of manipulative physical therapy, physical therapy intervention and therapy by general practitioner (GP) for persistent general LBP and neck pain was investigated on 256 patients how didn't received any of the above therapy in last two years were contained in this study. Physical therapy included workout exercises, massage, and physical therapy (related to hot pack, different pain modalities like therapeutic ultrasound, shortwave diathermy, and electrotherapy). Manual therapy includes manual reduction by manipulation and mobilization of the back. Interventions received by GP is medicine related (different types of pain killer and muscles relaxant), guidance about the posture, home plan exercises and different healthy activities and proper rest. Placebo intervention included adjustable shortwave diathermy session for (10 minutes), and adjusted therapeutic ultrasound session for (10 minutes). Recovery rate in the leading complaint was increased with the group receiving manual therapy intervention (4.5) as compare to physical therapy (3.8), after a detailed one year of continuous therapy. There is a great progression seen in physical work by manual therapy. Moreover, manipulation is get going improved gradually, as compare to physiotherapy following in period of 12 months.
The first meta-analysis estimated the efficacy of SMT for LBP due to LDH with other therapies come to the result that SMT was equally effective when compare to other traditional therapies. However a past systematic review was come to the conclusion that SMT was secure and effective in relation to its costs for managing SLDD like LDH, that conclusion was quoted to promote by a very few publications.
One of the present research studies after one year of continuation showed decrease in pain and increase in recreational activities to a long period of time, an additional research work in 2016 described, a remarkable progression in sciatica after 30 days, in patients with lumber discs extrusion and sequestration, as a result of HVLA thrust.
In spite of the factor that there is only average numbers of documentation in the written work which promoted the utilization of SMT to manage LDH, it is extensively applied by therapist.
the comparison of cyriax manipulation and decompresion is an important adding to the researches in evidence based practices. there is no such work done before on comparison of both intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cyriax manipulation | Experimental | Other: cyriax manipulation lumbercyriax manipulation have three types of classes, rotation, extension and anti-deviation, which is further divided into subclasses. On the inferior level of lumber spine L4-L5 and L5-S1rotation intervention of manipulation are capable of having striking effects of decreasing herniation. First of all we have to perform the simple 'stretch' on lumber spine, which is being the little rotation pressure applied on the body. The patient position of the body is in side lying with the effected side upward so that the outside part of the joint are separated easily on the involved side. After that, whenever it is essential by making use of femur as a rigid bar or support, this maneuver is go along with powerful rotation technique. |
| lumber decompresion | Experimental | Other: lumber decompressionSpinal decompression therapy has been developed a treatment without surgery for the prolapsed disc and deteriorative spinal disc disease one of the considerable reason for low back pain. This noninvasive interventional treatment for herniated disc and deteriorative disc diseases operated on the principle of remarkably decreasing the pressure on the disc between vertebras. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients having Lumber disc prolapse of L1-L5 and S1 (both gender)
- Patients having MRI reports of protruded disc
Key exclusion criteria (4 listed)
- Inflammatory condition( systemic inflammatory disease of spine)
- Spinal diseases (other than Musculoskeletal)
- Severe radiculopathies (bilateral)
- Operated patients (spine)
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 |
|---|---|---|
| cyriax manipulation lumberIn group A patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Cyriax manipulation. Exercises (Guided low back exercises, 3-5times/day). Ankle pumping (5-10 repetition with 15-20 second hold), Quads Isometric (5-10 repetition with 15-20 second hold), Hams \& Calf stretching (5-10 repetition with 15-20 second hold), Bridging (5-10 repetition with 15-20 second hold), Prone Back extension (10 repetition) Precaution Prevent yourself from sitting low on ground, Sitting with support will be directed and be careful during driving and ascending stairs. Cyriax Manipulation: 2-3 repetitions/session, 2 session/week Lumbar spinal manipulation Rotation Techniques Lumbar spinal manipulation Extension Techniques Lumbar spinal manipulation Antideviation Techniques total of 4 session were given. 2 session/week. | Other | cyriax manipulation |
| lumber decompressionGroup B: In group B patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Decompression Session. Conservative therapy: Same as Group A Lumbar spine decompression: 30 Minutes Session (generalized time for every one) . On the account of MRI description level is recommended and acknowledged by MRI the level of disc protrusion, decompression is operated. Patient is lying on table facing upward. For locking of the patient's body it was secured by pelvis and thoracic straps. One part of the decompression table is immobile other is movable. Bottom extreme part of the table is mobile. Estimation of weight of patient is first thing to do. We calculated it by division of whole weight by 5 and that 5th segment of weight was utilized as an interventional pound for decompression. . | Other | lumber decompresion |
Primary outcome
Inclinometer
Time frame: 2nd week
Inclinometer: Dual inclinometer is used to measure dynamic ROM of lumber spine. For measuring the ROM of flexion, extension and side bending to both sides, place one inclinometer on T12 and the other on S1. Ask the patient to bend forward for flexion, bend backward for extension and sideways for side bending. Note both the readings and subtract the lower one from the above.
goniometer
Time frame: 2nd week
Goniometer is used to measure SLR range before and after the treatment For the patients to perform SLR, participants lay supine on a table and are asked to actively raise their leg from the table while keeping their knee straight. Reproduction of the patient's characteristic pain or demonstration of weakness can lead to decreased range of SLR. Symptom production between the ranges of 30 degrees to 60 degrees is an indication of disc pathology.
Numeric pain rating scale
Time frame: 2nd week
Numeric pain rating scale: Pain is measured by NPRS before Treatment and after treatment. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the pain where zero is no pain and 10 is maximum pain (for back and leg)
Oswestry disability index (ODI)
Time frame: 2nd week
Oswestry disability index (ODI): Disability is measured by ODI before Treatment and after treatment. It is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. it consist of 10, five parts sections. at the end,s core is calculated by dividing the obtained score by total 50, and multiplied by 100. as the sexual section is missing due to ethical reason so total score is 45 instead of 50.
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 4 Dec 2020.
- Background: PubMed 31453485Kocak FA, Tunc H, Tomruk Sutbeyaz S, Akkus S, Koseoglu BF, Yilmaz E. Comparison of the short-term effects of the conventional motorized traction with non-surgical spinal decompression performed with a DRX9000 device on pain, functionality, depression, and quality of life in patients with low back pain associated with lumbar disc herniation: A single-blind randomized-controlled trial. Turk J Phys Med Rehabil. 2017 Feb 16;64(1):17-27. doi: 10.5606/tftrd.2017.154. eCollection 2018 Mar.
- Background: PubMed 1532760Koes BW, Bouter LM, van Mameren H, Essers AH, Verstegen GM, Hofhuizen DM, Houben JP, Knipschild PG. Randomised clinical trial of manipulative therapy and physiotherapy for persistent back and neck complaints: results of one year follow up. BMJ. 1992 Mar 7;304(6827):601-5. doi: 10.1136/bmj.304.6827.601.
- Background: PubMed 24636109Leemann S, Peterson CK, Schmid C, Anklin B, Humphreys BK. Outcomes of acute and chronic patients with magnetic resonance imaging-confirmed symptomatic lumbar disc herniations receiving high-velocity, low-amplitude, spinal manipulative therapy: a prospective observational cohort study with one-year follow-up. J Manipulative Physiol Ther. 2014 Mar-Apr;37(3):155-63. doi: 10.1016/j.jmpt.2013.12.011. Epub 2014 Mar 11.
- Background: PubMed 27034106Ehrler M, Peterson C, Leemann S, Schmid C, Anklin B, Humphreys BK. Symptomatic, MRI Confirmed, Lumbar Disc Herniations: A Comparison of Outcomes Depending on the Type and Anatomical Axial Location of the Hernia in Patients Treated With High-Velocity, Low-Amplitude Spinal Manipulation. J Manipulative Physiol Ther. 2016 Mar-Apr;39(3):192-9. doi: 10.1016/j.jmpt.2016.02.013. Epub 2016 Mar 28.
- BackgroundOh H-J, Jeon C-B, Jeong M-G, Choi S-J. The effects of spinal decompression therapy on pain and disability in patients with chronic low back pain. The Journal of Korean Physical Therapy. 2017;29(6):299-302.
- 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.
Affan Iqbal, Phd* principal investigator
Riphah International 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 cyriax manipulation lumber and lumber decompression in people with Lumbar Disc Herniation, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 4 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 4 Dec 2020. 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 Pakistan. 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?
Inclinometer (time frame: 2nd week). The study lists 4 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 NCT04653870, which also lists 5 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 4 Dec 2020.