TendinopathyNCT02938143
Exercise Therapy for Patellar Tendinopathy Evaluated With Advanced UTE-MRI
A study testing Exercise in people with Tendinopathy, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance in jumping athletes. Exercise therapy is considered the best initial treatment option for tendinopathies as clinical improvements in pain and function have been demonstrated. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2017to Jan 2024
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-35 years old (the chosen age range will minimize chances of other conditions causing anterior knee pain such as osteoarthritis and osteochondrotic diseases like Sinding-Larsen-Johansson syndrome and Osgood-Schlatter disease) History of knee pain in patellar tendon or its patellar or tibial insertion in association with training and competition Playing sports for at least 3 times a week Palpation tenderness to the corresponding painful area On ultrasound, there needs to be a fusiform tendon thickening and/or decreased tendons structure and/or increased Doppler signal within the patellar tendon27 VISA-P score < 80/100 points
Who cannot join
- Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout or rheumatoid arthritis) or familial hypercholesterolaemia.
- Contraindications for MRI (pregnancy, metallic implants, etc.) Daily use of drugs with a putative effect on the patellar tendon in the preceding year (e.g. fluoroqinolones and statins) Knee surgery in the history of the index knee Previous patellar tendon rupture of the index knee Local injection therapy with corticosteroids in the preceding 12 months Daily exercise therapy with a minimum duration of 4 weeks in total in the preceding 12 months Acute knee or patellar tendon injuries Inability to perform an exercise program Participation in other concomitant treatment programs Signs or symptoms of other coexisting knee pathology on physical examination (such as joint effusion and joint line tenderness) or additional diagnostics (Chondral lesion of the patella or trochlea on MRI or prepatellar bursitis on US).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Tendon-loading Exercise Therapy for Patellar Tendinopathy in Jumping Athletes: A Randomized Controlled Clinical Trial Evaluated With Advanced 3D UTE MR
Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance in jumping athletes. Exercise therapy is considered the best initial treatment option for tendinopathies as clinical improvements in pain and function have been demonstrated. Although painful eccentric exercise protocols have been promoted as standard care based on positive results in early studies, a recent systematic review demonstrated that these are not associated with improved tendon structure and are ineffective when applied in-season. Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based exercise protocol as it results in a less reactive tendon and ability to restore collagen alignment. This protocol consists of progressive isometric, isotonic, plyometric, and sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to resume sports within the limits of pain, with improved muscle function, and sufficient tendon structure re-organization. The diagnostic imaging work-up of patellar tendinopathy typically consists of ultrasound, magnetic resonance imaging (MRI), or a combination of both. Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment of tissues with short T2-time, such as tendon, the structure of which is invisible on regular MRI. UTE has been shown to quantitatively depict changes in tendon microstructure and therefore allows in-vivo evaluation of tendon regeneration. It is currently unknown whether quantitative UTE MRI parameters change after exercise treatment, are related to clinical symptoms of patellar tendinopathy, have prognostic value for exercise treatment response, and offer additional value over ultrasound
Read the detailed description
Patellar tendinopathy ('jumper's knee') is a clinical condition of gradually progressive activity-related pain at the insertion of the patellar tendon at the apex patellae. Prolonged repetitive stress of the knee-extensor apparatus can lead to this common overuse tendinopathy in athletes from different sports, resulting in pain and impaired performance in athletes. High prevalence rates have been reported in jumping sports such as volleyball and basketball (45% and 32% in elite athletes, respectively). Symptoms can be long-standing if not treated appropriately in the initial stages. Furthermore, there is currently no strong evidence for second-line treatments such as shockwave therapy and platelet-rich plasma. Therefore, it is important to improve exercise protocols as a first treatment of choice.
Tendinopathy is a widely accepted, generic term that encompasses any abnormal condition of a tendon. Clinical symptoms include activity-related pain associated with tenderness, localized swelling and impaired performance. Histopathologically, tendinopathy is characterized by structural disorganization of the tendon collagen that alters the loading capacity of a specific tendon.
Exercise therapy is considered as the best initial treatment option for tendinopathies as histopathological changes and clinical improvements on pain and function have been demonstrated. Most studies have been conducted using eccentric exercise protocols and early studies showed positive effects, resulting in promoting these isolated painful exercises as standard care. One hypothesis behind the potential beneficial effects of eccentric exercises is that increased load results in increased collagen synthesis and subsequent healing response. However, a recent systematic review demonstrated that the available literature does not support observable structural change as an explanation for the response of eccentric exercises. Furthermore, eccentric exercises may not be effective for reducing pain and improving strength when used in-season and might even increase symptoms in jumping athletes with patellar tendon pathology.
Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent publication advocates a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises, resulting in a less reactive tendon, immediate decreased pain levels, diminished motor cortex inhibition of the quadriceps muscles, and potential to restore collagen alignment. These new insights are completely conflicting with the painful heavy-load eccentric exercise protocols currently applied as usual care. It is currently unknown which exercise therapy is the best strategy for athletes with patellar tendinopathy, as adequately powered randomized studies are lacking.
Although clinical examination represents the gold standard in the diagnosis of patellar tendinopathy, it is commonplace to perform diagnostic imaging of the patellar tendon to confirm the diagnosis and rule out alternative diagnoses. Furthermore, imaging can be used to estimate response to treatment. This diagnostic imaging work-up usually consists of magnetic resonance imaging (MRI), ultrasound or, occasionally, a combination of both. On "regular" MRI, increased tendon size and visually increased signal intensity within the proximal patellar tendon can be observed in patellar tendinopathy , but altered tendon microstructure is invisible. A novel innovative method to detect tendon abnormalities is the ultrashort echo time (UTE) MRI technique. UTE enables accurate detection of changes in a reactive tendon both visually and in a quantitative manner by measuring T2* relaxation time UTE MRI has also been shown to quantitatively depict changes in tendon microstructure and, therefore, this innovative imaging modality allows in-vivo evaluation of tendon regeneration. It is currently unknown whether quantitative UTE MRI parameters change after exercise treatment, are related to clinical symptoms of patellar tendinopathy, and have prognostic value for exercise treatment response.
- Conditions
- Tendinopathy
- Being tested
- Exercise, Exercise (usual care)
- Keywords
- Jumpers knee, Patellar Tendinopathy, Jumping Athletes, UTE MRI, Exercise Therapy, NBA
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
The intervention treatment is a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises.24 Progression criteria are individualized.
Exercise (usual care)Procedure or surgery
The control treatment is a painful heavy-load eccentric exercise program performed twice daily with 3 sets of 15 repetitions for 12 weeks on a 25° decline board. The downward component (eccentric component) will be performed with the symptomatic leg and the upward component (concentric phase) on the asymptomatic leg.
| Study group | Role | What they receive |
|---|---|---|
| 4-stage criteria-based exercise protocol | Experimental | a progressive 4-stage criteria-based exercise protocol within the limits of pain Receives: Procedure: Exercise |
| Heavy-load eccentric exercise protocol | Active comparator | a 12-week painful heavy-load eccentric exercise protocol Receives: Procedure: Exercise (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the validated and disease-specific VISA-P score over 24 weeks
The change of the validated and disease-specific VISA-P score over 24 weeks
Measured: 24 weeks
Secondary outcomes (10)
Subjective patient satisfaction
Subjective patient satisfaction (excellent / good / fair / poor)
Measured: 3 years
Return to sports
Return to sports (Return to desired sport on pre-injury level / return to desired sport but on a lower level / return to sports but not desired sport / no return to sports
Measured: 3 years
Time to return to full training in desired sport
Time to return to full training in desired sport
Measured: 3 years
Pain rating on a Visual Analogue Scale (VAS)
Pain rating on a Visual Analogue Scale (VAS) in which 0 represents no pain, and 100 maximal pain
Measured: 3 years
Strength (N.kg.m) of the abductors and quadriceps muscles using dynamometry
Strength (N.kg.m) of the abductors and quadriceps muscles using dynamometry Leg length of the upper extremity will be measured to be able to correct for lever arm.
Measured: 3 years
Flexibility of the calf muscles using the weight-bearing dorsiflexion lunge tes
Flexibility of the calf muscles using the weight-bearing dorsiflexion lunge tes
Measured: 3 years
Compliance to the exercise program (total percentage of prescribed exercises performed).
Compliance to the exercise program (total percentage of prescribed exercises performed). This will be asked on a weekly basis using a short online questionnaire.
Measured: 3 years
Training load
Training load, which is defined as: Total duration of training and match play per week (minutes) multiplied by the experienced intensity of training sessions and games using the modified Borg CR-10 RPE scale.46 This will be asked on a weekly basis using a short online questionnaire.
Measured: 3 years
MRI: Conventional: maximum anterior-posterior (AP) thickness and signal abnormalities
Conventional: maximum anterior-posterior (AP) thickness and signal abnormalities (intratendinous, peritendinous).
Measured: 3 years
MRI: 3D UTE Cones: T2* relaxation time
3D UTE Cones: T2* relaxation time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2024 (estimated)
- Study completionJan 2024 (estimated)
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 TendinopathyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Edwin Oei, Erasmus Medical Center
- Investigators
- Edwin H Oei, Dr, Principal investigator, Erasmus Medical CenterRobert-Jan de Vos, Dr., Principal investigator, Erasmus Medical CenterS Breda, Drs., Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938143
- Sponsor's protocol ID
- UTE MRI
- Status last verified
- Mar 2022
- First submitted
- 3 Oct 2016
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Deng J, Breda SJ, Eygendaal D, Oei EH, de Vos RJ. Association Between Physical Tests and Patients-Reported Outcomes in Athletes Performing Exercise Therapy for Patellar Tendinopathy: A Secondary Analysis of the JUMPER Study. Am J Sports Med. 2023 Nov;51(13):3523-3532. doi: 10.1177/03635465231200241. Epub 2023 Oct 10.
PubMed 37815096
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Tendon-loading Exercise Therapy for Patellar Tendinopathy in Jumping Athletes: A Randomized Controlled Clinical Trial Evaluated With Advanced 3D UTE MR
- ClinicalTrials.gov ID
- NCT02938143
- Acronym / sponsor ID
- UTE MRI
- Conditions
- Tendinopathy
- Keywords
- Jumpers knee, Patellar Tendinopathy, Jumping Athletes, UTE MRI, Exercise Therapy, NBA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Oct 2016 (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.
Patellar tendinopathy is a frequent overuse injury that causes pain and impaired performance in jumping athletes. Exercise therapy is considered the best initial treatment option for tendinopathies as clinical improvements in pain and function have been demonstrated. Although painful eccentric exercise protocols have been promoted as standard care based on positive results in early studies, a recent systematic review demonstrated that these are not associated with improved tendon structure and are ineffective when applied in-season. Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent study advocates a progressive 4-stage criteria-based exercise protocol as it results in a less reactive tendon and ability to restore collagen alignment. This protocol consists of progressive isometric, isotonic, plyometric, and sport-specific exercises. Isometric exercises have been shown to reduce pain and decrease motor cortex inhibition of the quadriceps. This approach would enable jumping athletes to resume sports within the limits of pain, with improved muscle function, and sufficient tendon structure re-organization. The diagnostic imaging work-up of patellar tendinopathy typically consists of ultrasound, magnetic resonance imaging (MRI), or a combination of both. Ultrashort echo time (UTE) MRI is an advanced MRI technique, which enables assessment of tissues with short T2-time, such as tendon, the structure of which is invisible on regular MRI. UTE has been shown to quantitatively depict changes in tendon microstructure and therefore allows in-vivo evaluation of tendon regeneration. It is currently unknown whether quantitative UTE MRI parameters change after exercise treatment, are related to clinical symptoms of patellar tendinopathy, have prognostic value for exercise treatment response, and offer additional value over ultrasound
Detailed description
Patellar tendinopathy ('jumper's knee') is a clinical condition of gradually progressive activity-related pain at the insertion of the patellar tendon at the apex patellae. Prolonged repetitive stress of the knee-extensor apparatus can lead to this common overuse tendinopathy in athletes from different sports, resulting in pain and impaired performance in athletes. High prevalence rates have been reported in jumping sports such as volleyball and basketball (45% and 32% in elite athletes, respectively). Symptoms can be long-standing if not treated appropriately in the initial stages. Furthermore, there is currently no strong evidence for second-line treatments such as shockwave therapy and platelet-rich plasma. Therefore, it is important to improve exercise protocols as a first treatment of choice.
Tendinopathy is a widely accepted, generic term that encompasses any abnormal condition of a tendon. Clinical symptoms include activity-related pain associated with tenderness, localized swelling and impaired performance. Histopathologically, tendinopathy is characterized by structural disorganization of the tendon collagen that alters the loading capacity of a specific tendon.
Exercise therapy is considered as the best initial treatment option for tendinopathies as histopathological changes and clinical improvements on pain and function have been demonstrated. Most studies have been conducted using eccentric exercise protocols and early studies showed positive effects, resulting in promoting these isolated painful exercises as standard care. One hypothesis behind the potential beneficial effects of eccentric exercises is that increased load results in increased collagen synthesis and subsequent healing response. However, a recent systematic review demonstrated that the available literature does not support observable structural change as an explanation for the response of eccentric exercises. Furthermore, eccentric exercises may not be effective for reducing pain and improving strength when used in-season and might even increase symptoms in jumping athletes with patellar tendon pathology.
Progressive tendon-loading exercise therapy for patellar tendinopathy constitutes a novel concept in sports medicine. A recent publication advocates a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises, resulting in a less reactive tendon, immediate decreased pain levels, diminished motor cortex inhibition of the quadriceps muscles, and potential to restore collagen alignment. These new insights are completely conflicting with the painful heavy-load eccentric exercise protocols currently applied as usual care. It is currently unknown which exercise therapy is the best strategy for athletes with patellar tendinopathy, as adequately powered randomized studies are lacking.
Although clinical examination represents the gold standard in the diagnosis of patellar tendinopathy, it is commonplace to perform diagnostic imaging of the patellar tendon to confirm the diagnosis and rule out alternative diagnoses. Furthermore, imaging can be used to estimate response to treatment. This diagnostic imaging work-up usually consists of magnetic resonance imaging (MRI), ultrasound or, occasionally, a combination of both. On "regular" MRI, increased tendon size and visually increased signal intensity within the proximal patellar tendon can be observed in patellar tendinopathy , but altered tendon microstructure is invisible. A novel innovative method to detect tendon abnormalities is the ultrashort echo time (UTE) MRI technique. UTE enables accurate detection of changes in a reactive tendon both visually and in a quantitative manner by measuring T2* relaxation time UTE MRI has also been shown to quantitatively depict changes in tendon microstructure and, therefore, this innovative imaging modality allows in-vivo evaluation of tendon regeneration. It is currently unknown whether quantitative UTE MRI parameters change after exercise treatment, are related to clinical symptoms of patellar tendinopathy, and have prognostic value for exercise treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-stage criteria-based exercise protocol | Experimental | Procedure: Exercisea progressive 4-stage criteria-based exercise protocol within the limits of pain |
| Heavy-load eccentric exercise protocol | Active comparator | Procedure: Exercise (usual care)a 12-week painful heavy-load eccentric exercise protocol |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-35 years old (the chosen age range will minimize chances of other conditions causing anterior knee pain such as osteoarthritis and osteochondrotic diseases like Sinding-Larsen-Johansson syndrome and Osgood-Schlatter disease) History of knee pain in patellar tendon or its patellar or tibial insertion in association with training and competition Playing sports for at least 3 times a week Palpation tenderness to the corresponding painful area On ultrasound, there needs to be a fusiform tendon thickening and/or decreased tendons structure and/or increased Doppler signal within the patellar tendon27 VISA-P score < 80/100 points
Key exclusion criteria (2 listed)
- Known presence of inflammatory joint diseases (e.g. spondylarthropathy, gout or rheumatoid arthritis) or familial hypercholesterolaemia.
- Contraindications for MRI (pregnancy, metallic implants, etc.) Daily use of drugs with a putative effect on the patellar tendon in the preceding year (e.g. fluoroqinolones and statins) Knee surgery in the history of the index knee Previous patellar tendon rupture of the index knee Local injection therapy with corticosteroids in the preceding 12 months Daily exercise therapy with a minimum duration of 4 weeks in total in the preceding 12 months Acute knee or patellar tendon injuries Inability to perform an exercise program Participation in other concomitant treatment programs Signs or symptoms of other coexisting knee pathology on physical examination (such as joint effusion and joint line tenderness) or additional diagnostics (Chondral lesion of the patella or trochlea on MRI or prepatellar bursitis on US).
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 |
|---|---|---|
| ExerciseThe intervention treatment is a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises.24 Progression criteria are individualized. | Procedure or surgery | 4-stage criteria-based exercise protocol |
| Exercise (usual care)The control treatment is a painful heavy-load eccentric exercise program performed twice daily with 3 sets of 15 repetitions for 12 weeks on a 25° decline board. The downward component (eccentric component) will be performed with the symptomatic leg and the upward component (concentric phase) on the asymptomatic leg. | Procedure or surgery | Heavy-load eccentric exercise protocol |
Primary outcome
The change of the validated and disease-specific VISA-P score over 24 weeks
Time frame: 24 weeks
The change of the validated and disease-specific VISA-P score over 24 weeks
10 secondary outcomes
Subjective patient satisfaction
Time frame: 3 years
Return to sports
Time frame: 3 years
Time to return to full training in desired sport
Time frame: 3 years
Pain rating on a Visual Analogue Scale (VAS)
Time frame: 3 years
Strength (N.kg.m) of the abductors and quadriceps muscles using dynamometry
Time frame: 3 years
Flexibility of the calf muscles using the weight-bearing dorsiflexion lunge tes
Time frame: 3 years
Compliance to the exercise program (total percentage of prescribed exercises performed).
Time frame: 3 years
Training load
Time frame: 3 years
MRI: Conventional: maximum anterior-posterior (AP) thickness and signal abnormalities
Time frame: 3 years
MRI: 3D UTE Cones: T2* relaxation time
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Derived from this study: PubMed 37815096Deng J, Breda SJ, Eygendaal D, Oei EH, de Vos RJ. Association Between Physical Tests and Patients-Reported Outcomes in Athletes Performing Exercise Therapy for Patellar Tendinopathy: A Secondary Analysis of the JUMPER Study. Am J Sports Med. 2023 Nov;51(13):3523-3532. doi: 10.1177/03635465231200241. Epub 2023 Oct 10.
- 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.
Edwin H Oei, Dr principal investigator
Erasmus Medical Center
Robert-Jan de Vos, Dr. principal investigator
Erasmus Medical Center
S Breda, Drs. principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Tendinopathy, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 inclusion and 2 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 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Results are not available in the source record.
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?
The change of the validated and disease-specific VISA-P score over 24 weeks (time frame: 24 weeks). 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 NCT02938143, 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 23 Mar 2022.