Anterior Knee Pain SyndromeNCT04119310
Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain
A study testing Lumbar-thrust mobilization in people with Anterior Knee Pain Syndrome, run by Messiah College.
Trial summary
The purpose of this study is to investigate changes in lateral hip muscle strength as well as self-reported pain during the performance of three functional tests in patients with anterior knee pain following a lumbopelvic thrust-mobilization. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Knee Pain Syndrome
- What is being tested?
- Lumbar-thrust mobilization
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 31 May 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males and females between the ages of 18 and 25 with non-traumatic anterior knee pain
- Able read and write in English
- Clearly understand the informed consent form
Who cannot join
- Low back pain
- Pregnant or may be pregnant
- Previously diagnosed with spondylolisthesis,
- Previously diagnosed with a herniated disc,
- Signs and symptoms of nerve root compression
- History of spine surgery
Show all 17Show fewer
- History of knee surgery
- History of cancer
- History of compression fracture
- History of osteoporosis
- History of osteopenia
- History of a systemic disease
- History of a connective tissue disease
- History of a neurological disease
- Pain with pre-manipulative hold
- Positive findings on medical history form, or physical exam
- Presence of anxiety during the procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain, a Double Blind Randomized Control Trial
The purpose of this study is to investigate changes in lateral hip muscle strength as well as self-reported pain during the performance of three functional tests in patients with anterior knee pain following a lumbopelvic thrust-mobilization.
Hypothesis(es):
Lumbar thrust-mobilization will lead to increased lateral hip strength and decreased anterior knee pain during 3 functional activities (single leg step down, functional squat, drop jump).
Read the detailed description
The participant will complete a medical history form and undergo a brief physical exam of the lumbar spine and knees to include: lumbar range of motion and mobility testing, knee range of motion, palpation, and knee mobility testing. The participant will complete a hip strength test utilizing the Biodex System 4 Pro®. The participant will then perform three activities (single leg step down, squat, and drop jump from a 2 foot platform) and provide a self-reported knee pain measure with each activity. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. Th e participant will be positioned on a high-low treatment table to receive the assigned intervention. The participant will be positioned to receive either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three functional activities (single leg step down, squat, and drop jump from a 2 foot platform) while providing a self-reported pain measure after each activity. Follow-up measures at 15 minutes post-intervention and the final measure at 30 minutes post-intervention will be performed.
- Conditions
- Anterior Knee Pain Syndrome
- Being tested
- Lumbar-thrust mobilization, Sham thrust-mobilization
- Medical subject headings
- Patellofemoral Pain Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar-thrust mobilizationOther
Also called Grade 5 mobilization, manipulation
The intervention group will receive passive spinal rotational grade V thrust-mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V thrust- mobilization while stabilizing the uppermost shoulder.
Sham thrust-mobilizationOther
Subjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension passive range of motion without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
| Study group | Role | What they receive |
|---|---|---|
| Lumbar thrust-mobilization | Experimental | The investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position Receives: Other: Lumbar-thrust mobilization |
| Sham-mobilization | Sham comparator | No lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion. Receives: Other: Sham thrust-mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lateral hip strength
lateral isometric hip strength will be measured with Biodex system 4
Measured: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Change in pain with single leg step down
Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a single leg step down.
The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Measured: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Change in pain with double leg squat
Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a double leg squat.
The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Measured: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Change in pain with drop jump from 2 foot platform
Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a drop jump from a 2 foot platform.
The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Measured: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Nov 2019 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Anterior Knee 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
- Participants will be randomly assigned to one of two interventions, thrust-mobilization or sham mobilization.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Messiah College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119310
- Sponsor's protocol ID
- BergmannHumphrey
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
PubMed 29392329Bizzini M, Childs JD, Piva SR, Delitto A. Systematic review of the quality of randomized controlled trials for patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2003 Jan;33(1):4-20. doi: 10.2519/jospt.2003.33.1.4.
PubMed 12570282Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
PubMed 20118526Iverson CA, Sutlive TG, Crowell MS, Morrell RL, Perkins MW, Garber MB, Moore JH, Wainner RS. Lumbopelvic manipulation for the treatment of patients with patellofemoral pain syndrome: development of a clinical prediction rule. J Orthop Sports Phys Ther. 2008 Jun;38(6):297-309; discussion 309-12. doi: 10.2519/jospt.2008.2669. Epub 2008 Jan 22.
PubMed 18515959Sutlive TG, Mitchell SD, Maxfield SN, McLean CL, Neumann JC, Swiecki CR, Hall RC, Bare AC, Flynn TW. Identification of individuals with patellofemoral pain whose symptoms improved after a combined program of foot orthosis use and modified activity: a preliminary investigation. Phys Ther. 2004 Jan;84(1):49-61.
PubMed 14992676Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
PubMed 19765240Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.
PubMed 17154139Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
PubMed 17549951Cowan SM, Hodges PW, Bennell KL, Crossley KM. Altered vastii recruitment when people with patellofemoral pain syndrome complete a postural task. Arch Phys Med Rehabil. 2002 Jul;83(7):989-95. doi: 10.1053/apmr.2002.33234.
PubMed 12098160McCarthy MM, Strickland SM. Patellofemoral pain: an update on diagnostic and treatment options. Curr Rev Musculoskelet Med. 2013 Jun;6(2):188-94. doi: 10.1007/s12178-013-9159-x.
PubMed 23456237Dixit S, DiFiori JP, Burton M, Mines B. Management of patellofemoral pain syndrome. Am Fam Physician. 2007 Jan 15;75(2):194-202.
PubMed 17263214Pappas E, Wong-Tom WM. Prospective Predictors of Patellofemoral Pain Syndrome: A Systematic Review With Meta-analysis. Sports Health. 2012 Mar;4(2):115-20. doi: 10.1177/1941738111432097.
PubMed 23016077Waryasz GR, McDermott AY. Patellofemoral pain syndrome (PFPS): a systematic review of anatomy and potential risk factors. Dyn Med. 2008 Jun 26;7:9. doi: 10.1186/1476-5918-7-9.
PubMed 18582383Witvrouw E, Lysens R, Bellemans J, Cambier D, Vanderstraeten G. Intrinsic risk factors for the development of anterior knee pain in an athletic population. A two-year prospective study. Am J Sports Med. 2000 Jul-Aug;28(4):480-9. doi: 10.1177/03635465000280040701.
PubMed 10921638Powers CM. Rehabilitation of patellofemoral joint disorders: a critical review. J Orthop Sports Phys Ther. 1998 Nov;28(5):345-54. doi: 10.2519/jospt.1998.28.5.345.
PubMed 9809282
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain, a Double Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04119310
- Acronym / sponsor ID
- BergmannHumphrey
- Conditions
- Anterior Knee Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Messiah CollegeUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 8 Oct 2019 (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.
The purpose of this study is to investigate changes in lateral hip muscle strength as well as self-reported pain during the performance of three functional tests in patients with anterior knee pain following a lumbopelvic thrust-mobilization.
Hypothesis(es):
Lumbar thrust-mobilization will lead to increased lateral hip strength and decreased anterior knee pain during 3 functional activities (single leg step down, functional squat, drop jump).
Detailed description
The participant will complete a medical history form and undergo a brief physical exam of the lumbar spine and knees to include: lumbar range of motion and mobility testing, knee range of motion, palpation, and knee mobility testing. The participant will complete a hip strength test utilizing the Biodex System 4 Pro®. The participant will then perform three activities (single leg step down, squat, and drop jump from a 2 foot platform) and provide a self-reported knee pain measure with each activity. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. Th e participant will be positioned on a high-low treatment table to receive the assigned intervention. The participant will be positioned to receive either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three functional activities (single leg step down, squat, and drop jump from a 2 foot platform) while providing a self-reported pain measure after each activity. Follow-up measures at 15 minutes post-intervention and the final measure at 30 minutes post-intervention will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two interventions, thrust-mobilization or sham mobilization.
| Arm | Type | Receives |
|---|---|---|
| Lumbar thrust-mobilization | Experimental | Other: Lumbar-thrust mobilizationThe investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position |
| Sham-mobilization | Sham comparator | Other: Sham thrust-mobilizationNo lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and females between the ages of 18 and 25 with non-traumatic anterior knee pain
- Able read and write in English
- Clearly understand the informed consent form
Key exclusion criteria (17 listed)
- Low back pain
- Pregnant or may be pregnant
- Previously diagnosed with spondylolisthesis,
- Previously diagnosed with a herniated disc,
- Signs and symptoms of nerve root compression
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 |
|---|---|---|
| Lumbar-thrust mobilizationAlso: Grade 5 mobilization, manipulationThe intervention group will receive passive spinal rotational grade V thrust-mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V thrust- mobilization while stabilizing the uppermost shoulder. | Other | Lumbar thrust-mobilization |
| Sham thrust-mobilizationSubjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension passive range of motion without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying. | Other | Sham-mobilization |
Primary outcome
Change in lateral hip strength
Time frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
lateral isometric hip strength will be measured with Biodex system 4
Change in pain with single leg step down
Time frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a single leg step down. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Change in pain with double leg squat
Time frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a double leg squat. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Change in pain with drop jump from 2 foot platform
Time frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a drop jump from a 2 foot platform. The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Background: PubMed 29392329Saltychev M, Dutton RA, Laimi K, Beaupre GS, Virolainen P, Fredericson M. Effectiveness of conservative treatment for patellofemoral pain syndrome: A systematic review and meta-analysis. J Rehabil Med. 2018 May 8;50(5):393-401. doi: 10.2340/16501977-2295.
- Background: PubMed 12570282Bizzini M, Childs JD, Piva SR, Delitto A. Systematic review of the quality of randomized controlled trials for patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2003 Jan;33(1):4-20. doi: 10.2519/jospt.2003.33.1.4.
- Background: PubMed 20118526Powers CM. The influence of abnormal hip mechanics on knee injury: a biomechanical perspective. J Orthop Sports Phys Ther. 2010 Feb;40(2):42-51. doi: 10.2519/jospt.2010.3337.
- Background: PubMed 18515959Iverson CA, Sutlive TG, Crowell MS, Morrell RL, Perkins MW, Garber MB, Moore JH, Wainner RS. Lumbopelvic manipulation for the treatment of patients with patellofemoral pain syndrome: development of a clinical prediction rule. J Orthop Sports Phys Ther. 2008 Jun;38(6):297-309; discussion 309-12. doi: 10.2519/jospt.2008.2669. Epub 2008 Jan 22.
- Background: PubMed 14992676Sutlive TG, Mitchell SD, Maxfield SN, McLean CL, Neumann JC, Swiecki CR, Hall RC, Bare AC, Flynn TW. Identification of individuals with patellofemoral pain whose symptoms improved after a combined program of foot orthosis use and modified activity: a preliminary investigation. Phys Ther. 2004 Jan;84(1):49-61.
- Background: PubMed 19765240Boling M, Padua D, Marshall S, Guskiewicz K, Pyne S, Beutler A. Gender differences in the incidence and prevalence of patellofemoral pain syndrome. Scand J Med Sci Sports. 2010 Oct;20(5):725-30. doi: 10.1111/j.1600-0838.2009.00996.x.
- Background: PubMed 17154139Lesher JD, Sutlive TG, Miller GA, Chine NJ, Garber MB, Wainner RS. Development of a clinical prediction rule for classifying patients with patellofemoral pain syndrome who respond to patellar taping. J Orthop Sports Phys Ther. 2006 Nov;36(11):854-66. doi: 10.2519/jospt.2006.2208.
- Background: PubMed 17549951Robinson RL, Nee RJ. Analysis of hip strength in females seeking physical therapy treatment for unilateral patellofemoral pain syndrome. J Orthop Sports Phys Ther. 2007 May;37(5):232-8. doi: 10.2519/jospt.2007.2439.
- Background: PubMed 12098160Cowan SM, Hodges PW, Bennell KL, Crossley KM. Altered vastii recruitment when people with patellofemoral pain syndrome complete a postural task. Arch Phys Med Rehabil. 2002 Jul;83(7):989-95. doi: 10.1053/apmr.2002.33234.
- Background: PubMed 23456237McCarthy MM, Strickland SM. Patellofemoral pain: an update on diagnostic and treatment options. Curr Rev Musculoskelet Med. 2013 Jun;6(2):188-94. doi: 10.1007/s12178-013-9159-x.
- Background: PubMed 17263214Dixit S, DiFiori JP, Burton M, Mines B. Management of patellofemoral pain syndrome. Am Fam Physician. 2007 Jan 15;75(2):194-202.
- Background: PubMed 23016077Pappas E, Wong-Tom WM. Prospective Predictors of Patellofemoral Pain Syndrome: A Systematic Review With Meta-analysis. Sports Health. 2012 Mar;4(2):115-20. doi: 10.1177/1941738111432097.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Lumbar-thrust mobilization in people with Anterior Knee Pain Syndrome, run by Messiah College.
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 17 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: status not confirmed, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karl Bergmann, PT, ScD (717-796-1800 ext. 3339, kbergmann@messiah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lateral hip strength (time frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention). 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 NCT04119310, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.