Femoroacetabular Impingement SyndromePhase 1NCT07108647
In-Season Prevalence and Management of Hip and Groin Injuries in Competitive Athletes
A Phase 1 study testing Progressive Hip Strengthening Program and Progressive Muscle Relaxation in people with Femoroacetabular Impingement Syndrome, run by University of Calgary.
Trial summary
This study is focused on helping athletes with a common hip condition called femoroacetabular impingement (FAI) syndrome. FAI syndrome occurs when abnormal bone shapes around the hip joint cause friction during movement, leading to pain, reduced performance, and, over time, more serious injury. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Femoroacetabular Impingement Syndrome
- What is being tested?
- Progressive Hip Strengthening Program and Progressive Muscle Relaxation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- currently identifies as a "competitive athlete" based on the LTAD
- aged 14-40
- be free from any significant lower extremity injury (hip, groin, knee, ankle foot) in the past 6 months that resulted in >1 months of time loss or current inability to fully participate in sport at the time of baseline testing
- If participants meet the above criteria, can be screened:
- completed bilateral hip screen, including imaging, and identified as having FAI syndrome with no degenerative joint changes (if meet the remaining criteria,
Who cannot join
- Are currently experiencing or recovering from a lower extremity injury that resulted in >1 month time lost within the past 6 months
- are pregnant or may become pregnant during the study (due to radiographic imaging exposure)
- * participants will be excluded from eligibility of RCT if they have evidence of moderate to severe osteoarthritis on imaging (Tönnis grade 2-3)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is focused on helping athletes with a common hip condition called femoroacetabular impingement (FAI) syndrome. FAI syndrome occurs when abnormal bone shapes around the hip joint cause friction during movement, leading to pain, reduced performance, and, over time, more serious injury. While this issue is well-studied in male professional athletes, little is known about how it affects female and collegiate athletes, or how to prevent it from worsening.
In this study, athletes diagnosed with FAI syndrome will participate in a 12-week in-season exercise program designed to reduce pain, improve hip strength and movement, and help prevent further injury-all while continuing their regular sports training.
Read more
Participants will be randomly assigned to either:
- An exercise group (receiving the intervention), or
- A time-and-attention control group (regular check-ins and education).
At the end of the study, the control group will have the option to access the exercise program.
The study will track changes in pain, physical performance, injury recurrence, and athlete satisfaction with the program. This research aims to improve how we manage hip injuries in athletes and help keep them active during the competitive season.
Read the detailed description
Study Rationale Femoroacetabular impingement (FAI) syndrome is a common source of hip pain in athletes participating in cutting, pivoting, and high-impact sports such as soccer, basketball, ice hockey, and ringette. It is characterized by abnormal contact between the femoral head and acetabulum, which may lead to cartilage damage, labral tears, and early osteoarthritis. While research has primarily focused on male professional athletes, there is limited evidence regarding the early management of FAI in younger, female, and collegiate athletes.
Current management strategies often emphasize post-season rehabilitation or surgical interventions, limiting opportunities to explore conservative strategies that allow continued play during the competitive season. This randomized controlled trial (RCT) addresses that gap by evaluating a novel, in-season, 12-week exercise intervention designed to mitigate symptoms, maintain sport participation, and potentially delay or reduce long-term structural damage.
Study Objectives
- Evaluate the feasibility of implementing an in-season, supervised exercise program in athletes with FAI syndrome.
- Explore preliminary effectiveness signals on functional outcomes and symptom progression.
Study Design Participants diagnosed with FAI syndrome based on clinical evaluation and symptom history will be randomized to either the intervention or a time-and-attention control group. The intervention group will complete a structured neuromuscular and hip-specific rehabilitation program, while the control group receives educational support and a progressive mobility and recovery (PMR) option during the same 12-week period. Randomization ensures balanced comparison of feasibility and clinical endpoints.
Intervention Protocol
The 12-week intervention focuses on:
- hip and core strength (e.g., isometric and isotonic exercises targeting hip flexors, abductors, adductors, and gluteals)
- neuromuscular control (e.g., drills for dynamic stability, pelvic alignment, and functional control)
- functional progression (e.g., graded loading to meet game demands)
Participants complete the exercises a minimum of 3 times/week, and will be trained at the start of each phase in-person or remotely by a trained clinician. Exercise progression will occur after 4 weeks per phase. Compliance is monitored through weekly questionnaires.
Control Group Protocol: Time and Attention Control + PMR Option The control group will not participate in the structured exercise program but will receive supportive follow-up and access to a three-phase progressive muscle relaxation (PMR) program (audio guided). This design ensures time and engagement are balanced across groups.
The control group protocol includes:
- scheduled check-ins every 4 weeks with the research team for education and monitoring
- educational modules on injury prevention, load management, and hip health
- access to a guided three-phase PMR program
While participation in the PMR component is optional, it offers a low-intensity, restorative alternative without introducing strength training or neuromuscular drills that may overlap with the primary intervention. Control group participants are also offered the full exercise protocol following study completion.
Significance
This is one of the first studies to investigate an in-season, non-operative intervention for FAI syndrome in athletes during competitive play. It targets a high-risk group (female and collegiate athletes), with potential to:
- fill a critical gap in early-stage, conservative management of FAI syndrome
- inform future sport- and sex-specific injury prevention programs
- guide clinical decision-making regarding rehabilitation timing and delivery
Feasibility findings will guide future larger-scale studies, including refined criteria for participant selection, adherence support, and integration within team-based medical models.
- Conditions
- Femoroacetabular Impingement Syndrome
- Being tested
- Progressive Hip Strengthening Program, Progressive Muscle Relaxation
- Keywords
- athletes, competitive, adolescent, young adult
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Hip Strengthening ProgramOther
This 12-week, in-season exercise intervention is designed for athletes with FAI syndrome and consists of three progressive phases.
Phase 1 (Weeks 1-4): Focus on neuromuscular re-education and motor control using low-load exercises to improve hip and core activation, alignment, and stability.
Phase 2 (Weeks 5-8): Targeted strengthening with increased load and movement complexity, emphasizing single-leg control, endurance, and pelvic stability.
Phase 3 (Weeks 9-12): Integration of dynamic control, proprioception, and sport-specific movement patterns to support return to performance.
Exercises target gluteus medius, gluteus maximus, core musculature, and functional movement systems. Participants complete the program >=3 times per week. Weekly questionnaires will monitor symptoms, adherence, and other management (e.g., physiotherapy).
Progressive Muscle RelaxationOther
Participants in the time and attention control group will complete a 12-week, three-phase progressive muscle relaxation (PMR) program based on the Jacobson method. Phase 1 introduces isolated muscle tensing and relaxing to build awareness of muscle tension and promote body-mind connection. Phase 2 focuses on sequential relaxation of muscle groups, enhancing control and reducing stress. Phase 3 transitions to full-body relaxation through guided breathing and visualization techniques. Sessions are practiced 2-3 times per week using audio guides, with weekly check-ins from study staff. Symptom response, adherence, and participant experience are tracked throughout the season.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention | Experimental | Participants in the experimental arm will complete a 12-week, in-season progressive exercise program designed to improve hip strength, motor control, and function.
Participants will complete a training session with a study trained clinician prior to beginning each respective phase of the program, either in person, or virtually per the participant preference.
Participants will have the option to complete the intervention following a guided video for each phase, or on their own, at a location of their choosing, a minimum of three times per week. Receives: Other: Progressive Hip Strengthening Program |
| Time and Attention Control | Sham comparator | Participants in the control arm will complete a 12-week, three-phase progressive muscle relaxation (PMR) program, adapted from the Jacobson method.
Participants will complete a training session with a study trained clinician prior to beginning each respective phase of the program, either in person, or virtually per the participant preference.
Participants will have the option to complete the intervention following a guided audio for each phase, at a location of their choosing, a minimum of three times per week. Receives: Other: Progressive Muscle Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Agreement to Screening
the number of participants whom agree to be screened/the number of participants approached for recruitment
Measured: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Eligibility Proportion
the number screened positive for inclusion (evidence of FAI syndrome)/number of participants who agreed to be screened (consented)
Measured: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Consent Proportion
Number of participants screened positive and agreed to participate in intervention/number screened positive for inclusion
Measured: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Randomization Proportion
The number of participants randomized/the number of participants screened positive and agreed to participate
Measured: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Trial-Arm Selection Proportion
The number agreed to each trial arm after randomization/the number of participants randomized
Measured: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Attrition Proportion
The number of participants who drop out of study/number of participants randomized in each arm
Measured: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Secondary outcomes (5)
International Hip Outcome Tool (iHOT-33)
The International Hip Outcome Tool (iHOT-33) is a 33-item patient-reported outcome measure designed to assess the health-related quality of life for young, active individuals with hip disorders. It focuses on how hip problems impact their daily activities, sports, work, and overall well-being. The iHOT-33 is a valuable tool for initial assessments, post-operative follow-ups, and clinical studies related to hip conditions.
Measured: 12 weeks
Copenhagen Hip and Groin Outcome Tool (HAGOS)
Patient-reported questionnaire designed to assess the impact of hip and/or groin problems on physical function and quality of life in young to middle-aged, physically active individuals.
Measured: 12 weeks
Make (Isometric) Strength Testing of the Hip
Strength measures in the hip (N/kg) performed in flexion, abduction, adduction. Measures will be performed pre and post intervention.
Measured: 12 weeks
Passive Range of Motion
Range of motion in degrees at the hip joint in flexion, internal rotation, abduction. Performed pre and post intervention.
Measured: 12 weeks
Special Test Findings
Positive or negative findings on special tests in the hip which reproduce the pain of an injury (out of a maximum of 3). Performed pre and post intervention.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carolyn Emery, PT, PhD, Principal investigator, Sport Injury Prevention Research Centre, Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108647
- Sponsor's protocol ID
- REB25-0338
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-Season Prevalence and Management of Hip and Groin Injuries in Competitive Athletes
- ClinicalTrials.gov ID
- NCT07108647
- Acronym / sponsor ID
- REB25-0338
- Conditions
- Femoroacetabular Impingement Syndrome
- Keywords
- athletes, competitive, adolescent, young adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 7 Aug 2025 (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.
This study is focused on helping athletes with a common hip condition called femoroacetabular impingement (FAI) syndrome. FAI syndrome occurs when abnormal bone shapes around the hip joint cause friction during movement, leading to pain, reduced performance, and, over time, more serious injury. While this issue is well-studied in male professional athletes, little is known about how it affects female and collegiate athletes, or how to prevent it from worsening.
In this study, athletes diagnosed with FAI syndrome will participate in a 12-week in-season exercise program designed to reduce pain, improve hip strength and movement, and help prevent further injury-all while continuing their regular sports training.
Participants will be randomly assigned to either:
- An exercise group (receiving the intervention), or
- A time-and-attention control group (regular check-ins and education).
At the end of the study, the control group will have the option to access the exercise program.
The study will track changes in pain, physical performance, injury recurrence, and athlete satisfaction with the program. This research aims to improve how we manage hip injuries in athletes and help keep them active during the competitive season.
Detailed description
Study Rationale Femoroacetabular impingement (FAI) syndrome is a common source of hip pain in athletes participating in cutting, pivoting, and high-impact sports such as soccer, basketball, ice hockey, and ringette. It is characterized by abnormal contact between the femoral head and acetabulum, which may lead to cartilage damage, labral tears, and early osteoarthritis. While research has primarily focused on male professional athletes, there is limited evidence regarding the early management of FAI in younger, female, and collegiate athletes.
Current management strategies often emphasize post-season rehabilitation or surgical interventions, limiting opportunities to explore conservative strategies that allow continued play during the competitive season. This randomized controlled trial (RCT) addresses that gap by evaluating a novel, in-season, 12-week exercise intervention designed to mitigate symptoms, maintain sport participation, and potentially delay or reduce long-term structural damage.
Study Objectives
- Evaluate the feasibility of implementing an in-season, supervised exercise program in athletes with FAI syndrome.
- Explore preliminary effectiveness signals on functional outcomes and symptom progression.
Study Design Participants diagnosed with FAI syndrome based on clinical evaluation and symptom history will be randomized to either the intervention or a time-and-attention control group. The intervention group will complete a structured neuromuscular and hip-specific rehabilitation program, while the control group receives educational support and a progressive mobility and recovery (PMR) option during the same 12-week period. Randomization ensures balanced comparison of feasibility and clinical endpoints.
Intervention Protocol
The 12-week intervention focuses on:
- hip and core strength (e.g., isometric and isotonic exercises targeting hip flexors, abductors, adductors, and gluteals)
- neuromuscular control (e.g., drills for dynamic stability, pelvic alignment, and functional control)
- functional progression (e.g., graded loading to meet game demands)
Participants complete the exercises a minimum of 3 times/week, and will be trained at the start of each phase in-person or remotely by a trained clinician. Exercise progression will occur after 4 weeks per phase. Compliance is monitored through weekly questionnaires.
Control Group Protocol: Time and Attention Control + PMR Option The control group will not participate in the structured exercise program but will receive supportive follow-up and access to a three-phase progressive muscle relaxation (PMR) program (audio guided). This design ensures time and engagement are balanced across groups.
The control group protocol includes:
- scheduled check-ins every 4 weeks with the research team for education and monitoring
- educational modules on injury prevention, load management, and hip health
- access to a guided three-phase PMR program
While participation in the PMR component is optional, it offers a low-intensity, restorative alternative without introducing strength training or neuromuscular drills that may overlap with the primary intervention. Control group participants are also offered the full exercise protocol following study completion.
Significance
This is one of the first studies to investigate an in-season, non-operative intervention for FAI syndrome in athletes during competitive play. It targets a high-risk group (female and collegiate athletes), with potential to:
- fill a critical gap in early-stage, conservative management of FAI syndrome
- inform future sport- and sex-specific injury prevention programs
- guide clinical decision-making regarding rehabilitation timing and delivery
Feasibility findings will guide future larger-scale studies, including refined criteria for participant selection, adherence support, and integration within team-based medical models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Other: Progressive Hip Strengthening ProgramParticipants in the experimental arm will complete a 12-week, in-season progressive exercise program designed to improve hip strength, motor control, and function. Participants will complete a training session with a study trained clinician prior to beginning each respective phase of the program, either in person, or virtually per the participant preference. Participants will have the option to complete the intervention following a guided video for each phase, or on their own, at a location of their choosing, a minimum of three times per week. |
| Time and Attention Control | Sham comparator | Other: Progressive Muscle RelaxationParticipants in the control arm will complete a 12-week, three-phase progressive muscle relaxation (PMR) program, adapted from the Jacobson method. Participants will complete a training session with a study trained clinician prior to beginning each respective phase of the program, either in person, or virtually per the participant preference. Participants will have the option to complete the intervention following a guided audio for each phase, at a location of their choosing, a minimum of three times per week. |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- currently identifies as a "competitive athlete" based on the LTAD
- aged 14-40
- be free from any significant lower extremity injury (hip, groin, knee, ankle foot) in the past 6 months that resulted in >1 months of time loss or current inability to fully participate in sport at the time of baseline testing
- completed bilateral hip screen, including imaging, and identified as having FAI syndrome with no degenerative joint changes (if meet the remaining criteria,
Key exclusion criteria (3 listed)
- Are currently experiencing or recovering from a lower extremity injury that resulted in >1 month time lost within the past 6 months
- are pregnant or may become pregnant during the study (due to radiographic imaging exposure)
- * participants will be excluded from eligibility of RCT if they have evidence of moderate to severe osteoarthritis on imaging (Tönnis grade 2-3)
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 |
|---|---|---|
| Progressive Hip Strengthening ProgramThis 12-week, in-season exercise intervention is designed for athletes with FAI syndrome and consists of three progressive phases. Phase 1 (Weeks 1-4): Focus on neuromuscular re-education and motor control using low-load exercises to improve hip and core activation, alignment, and stability. Phase 2 (Weeks 5-8): Targeted strengthening with increased load and movement complexity, emphasizing single-leg control, endurance, and pelvic stability. Phase 3 (Weeks 9-12): Integration of dynamic control, proprioception, and sport-specific movement patterns to support return to performance. Exercises target gluteus medius, gluteus maximus, core musculature, and functional movement systems. Participants complete the program >=3 times per week. Weekly questionnaires will monitor symptoms, adherence, and other management (e.g., physiotherapy). | Other | Exercise Intervention |
| Progressive Muscle RelaxationParticipants in the time and attention control group will complete a 12-week, three-phase progressive muscle relaxation (PMR) program based on the Jacobson method. Phase 1 introduces isolated muscle tensing and relaxing to build awareness of muscle tension and promote body-mind connection. Phase 2 focuses on sequential relaxation of muscle groups, enhancing control and reducing stress. Phase 3 transitions to full-body relaxation through guided breathing and visualization techniques. Sessions are practiced 2-3 times per week using audio guides, with weekly check-ins from study staff. Symptom response, adherence, and participant experience are tracked throughout the season. | Other | Time and Attention Control |
Primary outcome
Proportion of Agreement to Screening
Time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
the number of participants whom agree to be screened/the number of participants approached for recruitment
Eligibility Proportion
Time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
the number screened positive for inclusion (evidence of FAI syndrome)/number of participants who agreed to be screened (consented)
Consent Proportion
Time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
Number of participants screened positive and agreed to participate in intervention/number screened positive for inclusion
Randomization Proportion
Time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
The number of participants randomized/the number of participants screened positive and agreed to participate
Trial-Arm Selection Proportion
Time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
The number agreed to each trial arm after randomization/the number of participants randomized
Attrition Proportion
Time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention
The number of participants who drop out of study/number of participants randomized in each arm
5 secondary outcomes
International Hip Outcome Tool (iHOT-33)
Time frame: 12 weeks
Copenhagen Hip and Groin Outcome Tool (HAGOS)
Time frame: 12 weeks
Make (Isometric) Strength Testing of the Hip
Time frame: 12 weeks
Passive Range of Motion
Time frame: 12 weeks
Special Test Findings
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- 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.
Carolyn Emery, PT, PhD principal investigator
Sport Injury Prevention Research Centre, Chair
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Progressive Hip Strengthening Program and Progressive Muscle Relaxation in people with Femoroacetabular Impingement Syndrome, run by University of Calgary.
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 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Aug 2025. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maitland Martin, MSc, CAT(C), ATC (403-220-5332, hockeyhip@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Agreement to Screening (time frame: up to 9 months - study time frame is 12 months, with the last participant able to enroll at month 9 to allow for 12 weeks of intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.