Patellofemoral Pain SyndromeNCT06314360
Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Patellofemoral Pain Patients and Healthy Subjects
An observational study of Patellofemoral Pain Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Patellofemoral Pain Syndrome
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2024to Oct 2024
- Phase
- Observational
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects who are diagnosed with patellofemoral pain syndrome, and healthy subjects.
Who may be able to join
- Those who have been experiencing pain for at least 6 months
- Those who met the numerical pain criteria, defined as a minimum of 3 out of 10 points
- Having pain in the activities specifically identified as painful for PFP patients, including prolonged sitting, descending and ascending stairs/slopes, squatting, running, and jumping.
- Those who are without any complaints related to the lower extremities in the last 6 months
- Those who have not undergone lower extremity surgery for any reason
- Those who do not have a diagnosis of neurological or orthopedic diseases
Who cannot join
- Those with a history of lower extremity injury in the last 6 months
- Those who had patellofemoral dislocation and/or subluxation
- Those with meniscus and ligament lesions, bone anomalies
- Those who have undergone surgery on any lower extremity joint (hip, knee, or ankle)
- Those with a history of lower extremity injury in the last 6 months
- Those who are asymptomatic with a history of patellofemoral dislocation and/or subluxation
- Those who are asymptomatic with meniscus and ligament lesions, bone anomalies
- Those who have undergone lower extremity surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University
Ankara, Ankara/Sıhhıye, 06100
About this study
Official title: Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Individuals With Patellofemoral Pain and Healthy Individuals
Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. It is one of the most encountered knee injuries and can have a poor prognosis. The intensity of knee pain increases during functional activities such as stair climbing, squatting, running, and jumping due to the increased patellofemoral joint reaction force.
A disturbance in postural stability is observed in individuals with PFS due to pain during functional activities. Studies examining changes in foot posture, plantar pressure, and postural balance in individuals with PFS are quite limited and controversial. Moreover, research that simultaneously investigates these parameters and interprets the results is scarce. Some studies have utilized detailed technical systems such as medical imaging or motion analysis, while practical methods incorporating foot posture and plantar pressure analyses are available and easy to use in clinical settings.
Read more
There is a lack of literature on the easy assessment and interpretation of plantar pressure, postural balance, and functional activities in individuals with PFS. Within the scope of this project, the plan is to assess plantar pressure, postural balance, and functional activities in individuals with PFS. The aim is to quickly interpret the biomechanical changes occurring in these individuals and guide rehabilitation programs based on the obtained data.
The use of practical and fast assessment methods in planning treatments for PFS is crucial for early rehabilitation planning. Practical methods such as foot posture, plantar pressure, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The objective of this study is to compare the foot posture, plantar pressure, and postural stability of individuals with PFS with healthy individuals. Additionally, the investigators aim to investigate the relationship between foot posture, plantar pressure parameters, postural balance, and functional level in individuals with PFS. Through these objectives, it will be possible to identify potential parameters that could be effective in rehabilitation processes and contribute to determining treatment programs by revealing biomechanical changes in individuals with PFS.
Read the detailed description
PFS, commonly referred to as pain felt in the front or behind the kneecap, is a prevalent lower extremity problem. It most commonly affects adolescents and young adults, especially those engaged in sports such as cycling and running. Although its etiology is not fully explained, factors such as increased load on anatomical structures, repetitive movements with excessive degrees of knee flexion, patellofemoral malalignment, and muscle strength losses contribute to the pain. PFS is a frequently encountered musculoskeletal problem that adversely affects the quality of life and functional status in young adults.
Changes in lower extremity alignment (dynamic valgus, varus, tibial rotation, etc.) and alterations in foot position (increased pronation posture) are among the most important factors leading to PFS. Increased foot pronation during ground contact in walking and in static standing is suggested to trigger the development of PFS. Studies have shown that increased force and pressure distribution in the medial forefoot, midfoot, and heel after long-distance runs are associated with PFS. Conversely, there are studies suggesting no difference in foot posture between individuals with PFS and healthy individuals. One method that can be preferred to assess foot posture (in static or dynamic positions) is the measurement of plantar pressure distribution. This measurement method, based on plantar pressure distribution, is described as a safe and non-invasive method that allows the examination of changes related to the locomotor system, especially foot biomechanics. There are also systems that assess foot pressure distribution concurrently with evaluating foot position. Studies in the literature have demonstrated an association between foot pronation and increased plantar pressure in the medial foot in individuals with PFS. Additionally, there are studies indicating that the distribution of plantar pressure is similar between individuals with PFS and healthy individuals or that foot pronation is less in individuals with PFS compared to healthy individuals. Therefore, a clear conclusion in the literature regarding the foot plantar pressure in individuals with PFS has not yet been reached.
The severity of pain in PFS increases not only during daily life activities such as climbing stairs, squatting, and standing up from sitting but also during sports activities such as running and jumping. Studies show that during activities where weight is transferred to a single extremity, such as single-leg squatting, individuals with PFS experience decreased hip flexion, increased hip adduction and internal rotation, and disrupted pelvic alignment. It is suggested that if pelvic alignment cannot be maintained during weight transfer, postural balance will be negatively affected. The number of studies examining postural balance in individuals with PFS is limited, and a consensus has not been reached.
The evaluation methods used in the aforementioned studies generally rely on radiological imaging or motion analysis systems. Only a limited number of studies have utilized foot posture assessment and plantar pressure analysis. The different assessment methods used make it difficult to draw clear relationships between the results. Therefore, there is a need for a comprehensive study that evaluates parameters such as foot posture, plantar pressure, postural balance, and functional status together in individuals with PFS.
The use of practical and fast assessment methods is crucial in planning treatments for PFS to enable early rehabilitation planning. Therefore, practical methods such as foot posture, plantar pressure distribution, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The aim of this study is to compare the foot posture, plantar pressure distribution, and postural balance parameters of individuals with PFS with healthy individuals and to investigate the relationship between these parameters in individuals with PFS.
- Conditions
- Patellofemoral Pain Syndrome
- Being tested
- No intervention.
- Keywords
- patellofemoral pain, pedobarography, postural stability, foot posture, functionality
- 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.
No intervention.Other
There is no intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Patellofemoral Pain | Demographic data, pain information, limb dominancy will be collected. Then, functional status will be assessed with Kujala Patellofemoral Pain Form; foot posture will be evaluated with Foot Posture Index; plantar pressure and postural balance values will be collected with the K-Invent K-Plates device. Receives: Other: No intervention. | |
| Healthy Control Subjects | Demographic data, limb dominancy will be collected. Then, functional status will be assessed with Kujala Patellofemoral Pain Form; foot posture will be evaluated with Foot Posture Index; plantar pressure and postural balance values will be collected with the K-Invent K-Plates device. Receives: Other: No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plantar Pressure
Plantar pressure assessment will be performed with K-Invent K-Plates device. This device has two separate platforms measuring 320x160 mm. Participants will stand on the device with each foot on a platform and pressure data will be collected as max kg and weigth distribution.
Measured: 3 minutes, in the baseline assessment session.
Postural Stability
Postural stability assessment will be performed with K-Invent K-Plates device. This device has two separate platforms measuring 320x160 mm. While the participants are on the device with each foot on a platform, bipodal and then unipodal stance data will be collected respectively. Data will be collected three times for 50 seconds for each stance and stability data such as center of pressure, velocity and ellipse area will be recorded. Higher values show poor balance scores.
Measured: 20 minutes, in the baseline assessment session.
Foot posture
Foot Posture Index will be used to evaluate foot posture. FPI is a six-item clinical assessment tool used to evaluate foot posture. The six criteria used in the evaluation are talar head palpation, supra malleolar and infra malleolar curvature, position of the calcaneal in the frontal plane, protrusion in the talonavicular joint region, compliance of the medial longitudinal arch, and abduction/adduction of the forefoot. Each API component is scored from -2 to +2, with -2 representing clear signs of supination and +2 indicating positive signs of pronation. The total score ranges from -12 to +12. Total scores between 0 and +5 indicate normal/neutral foot posture. Values ≥ +6 are considered pronated foot, while values below 0 are considered supinated foot.
Measured: 5 minutes, in the baseline assessment session.
Functionality
Functional status will be assessed using Kujala Patellofemoral Pain Form. The questionnare consists of 13 questions. These questions ask whether there is pain during going up and down stairs, squatting, running, jumping and sitting for long periods with the knees flexed; It evaluates whether there is limp, swelling or subluxation of the patella, the amount of atrophy in the quadriceps muscle, flexion deficit and the need for a walking aid. The scoring system ranges from 0-100 points, from worst to best.
Measured: 3 minutes, in the baseline assessment session.
Secondary outcomes (2)
Pain Assessment
Pain will be evaluated using Numeric Analogue Scale. In this scale, the intensity of pain at the time of questioning will be recorded by the person choosing the value corresponding to the relevant number on a 10 cm long line shown between 0 (no pain) and 10 (unbearable pain). Two separate inquiries will be made, including pain at rest and during activity.
Measured: 1 minute, in the baseline assessment session.
Limb dominance
Limb dominance will be recorded by asking "Which leg do you prefer to kick a ball?". The answer to this question will be recorded as the dominant leg.
Measured: 30 seconds, in the baseline assessment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patellofemoral Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HANDE GUNEY, Hacettepe University
- Investigators
- Hande Guney, Principal investigator, Hacettepe University Faculty of Physical Therapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314360
- Sponsor's protocol ID
- BAP_PFS
- Status last verified
- Mar 2024
- First submitted
- 26 Jan 2024
- Last updated
- 18 Mar 2024
- 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 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Individuals With Patellofemoral Pain and Healthy Individuals
- ClinicalTrials.gov ID
- NCT06314360
- Acronym / sponsor ID
- BAP_PFS
- Conditions
- Patellofemoral Pain Syndrome
- Keywords
- patellofemoral pain, pedobarography, postural stability, foot posture, functionality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 18 Mar 2024 (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.
Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. It is one of the most encountered knee injuries and can have a poor prognosis. The intensity of knee pain increases during functional activities such as stair climbing, squatting, running, and jumping due to the increased patellofemoral joint reaction force.
A disturbance in postural stability is observed in individuals with PFS due to pain during functional activities. Studies examining changes in foot posture, plantar pressure, and postural balance in individuals with PFS are quite limited and controversial. Moreover, research that simultaneously investigates these parameters and interprets the results is scarce. Some studies have utilized detailed technical systems such as medical imaging or motion analysis, while practical methods incorporating foot posture and plantar pressure analyses are available and easy to use in clinical settings.
There is a lack of literature on the easy assessment and interpretation of plantar pressure, postural balance, and functional activities in individuals with PFS. Within the scope of this project, the plan is to assess plantar pressure, postural balance, and functional activities in individuals with PFS. The aim is to quickly interpret the biomechanical changes occurring in these individuals and guide rehabilitation programs based on the obtained data.
The use of practical and fast assessment methods in planning treatments for PFS is crucial for early rehabilitation planning. Practical methods such as foot posture, plantar pressure, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The objective of this study is to compare the foot posture, plantar pressure, and postural stability of individuals with PFS with healthy individuals. Additionally, the investigators aim to investigate the relationship between foot posture, plantar pressure parameters, postural balance, and functional level in individuals with PFS. Through these objectives, it will be possible to identify potential parameters that could be effective in rehabilitation processes and contribute to determining treatment programs by revealing biomechanical changes in individuals with PFS.
Detailed description
PFS, commonly referred to as pain felt in the front or behind the kneecap, is a prevalent lower extremity problem. It most commonly affects adolescents and young adults, especially those engaged in sports such as cycling and running. Although its etiology is not fully explained, factors such as increased load on anatomical structures, repetitive movements with excessive degrees of knee flexion, patellofemoral malalignment, and muscle strength losses contribute to the pain. PFS is a frequently encountered musculoskeletal problem that adversely affects the quality of life and functional status in young adults.
Changes in lower extremity alignment (dynamic valgus, varus, tibial rotation, etc.) and alterations in foot position (increased pronation posture) are among the most important factors leading to PFS. Increased foot pronation during ground contact in walking and in static standing is suggested to trigger the development of PFS. Studies have shown that increased force and pressure distribution in the medial forefoot, midfoot, and heel after long-distance runs are associated with PFS. Conversely, there are studies suggesting no difference in foot posture between individuals with PFS and healthy individuals. One method that can be preferred to assess foot posture (in static or dynamic positions) is the measurement of plantar pressure distribution. This measurement method, based on plantar pressure distribution, is described as a safe and non-invasive method that allows the examination of changes related to the locomotor system, especially foot biomechanics. There are also systems that assess foot pressure distribution concurrently with evaluating foot position. Studies in the literature have demonstrated an association between foot pronation and increased plantar pressure in the medial foot in individuals with PFS. Additionally, there are studies indicating that the distribution of plantar pressure is similar between individuals with PFS and healthy individuals or that foot pronation is less in individuals with PFS compared to healthy individuals. Therefore, a clear conclusion in the literature regarding the foot plantar pressure in individuals with PFS has not yet been reached.
The severity of pain in PFS increases not only during daily life activities such as climbing stairs, squatting, and standing up from sitting but also during sports activities such as running and jumping. Studies show that during activities where weight is transferred to a single extremity, such as single-leg squatting, individuals with PFS experience decreased hip flexion, increased hip adduction and internal rotation, and disrupted pelvic alignment. It is suggested that if pelvic alignment cannot be maintained during weight transfer, postural balance will be negatively affected. The number of studies examining postural balance in individuals with PFS is limited, and a consensus has not been reached.
The evaluation methods used in the aforementioned studies generally rely on radiological imaging or motion analysis systems. Only a limited number of studies have utilized foot posture assessment and plantar pressure analysis. The different assessment methods used make it difficult to draw clear relationships between the results. Therefore, there is a need for a comprehensive study that evaluates parameters such as foot posture, plantar pressure, postural balance, and functional status together in individuals with PFS.
The use of practical and fast assessment methods is crucial in planning treatments for PFS to enable early rehabilitation planning. Therefore, practical methods such as foot posture, plantar pressure distribution, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The aim of this study is to compare the foot posture, plantar pressure distribution, and postural balance parameters of individuals with PFS with healthy individuals and to investigate the relationship between these parameters in individuals with PFS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Patellofemoral Pain | – | Other: No intervention.Demographic data, pain information, limb dominancy will be collected. Then, functional status will be assessed with Kujala Patellofemoral Pain Form; foot posture will be evaluated with Foot Posture Index; plantar pressure and postural balance values will be collected with the K-Invent K-Plates device. |
| Healthy Control Subjects | – | Other: No intervention.Demographic data, limb dominancy will be collected. Then, functional status will be assessed with Kujala Patellofemoral Pain Form; foot posture will be evaluated with Foot Posture Index; plantar pressure and postural balance values will be collected with the K-Invent K-Plates device. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects who are diagnosed with patellofemoral pain syndrome, and healthy subjects.
Key inclusion criteria (6 listed)
- Those who have been experiencing pain for at least 6 months
- Those who met the numerical pain criteria, defined as a minimum of 3 out of 10 points
- Having pain in the activities specifically identified as painful for PFP patients, including prolonged sitting, descending and ascending stairs/slopes, squatting, running, and jumping.
- Those who are without any complaints related to the lower extremities in the last 6 months
- Those who have not undergone lower extremity surgery for any reason
Key exclusion criteria (8 listed)
- Those with a history of lower extremity injury in the last 6 months
- Those who had patellofemoral dislocation and/or subluxation
- Those with meniscus and ligament lesions, bone anomalies
- Those who have undergone surgery on any lower extremity joint (hip, knee, or ankle)
- Those with a history of lower extremity injury in the last 6 months
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 |
|---|---|---|
| No intervention.There is no intervention in this study. | Other | Healthy Control Subjects, Subjects with Patellofemoral Pain |
Primary outcome
Plantar Pressure
Time frame: 3 minutes, in the baseline assessment session.
Plantar pressure assessment will be performed with K-Invent K-Plates device. This device has two separate platforms measuring 320x160 mm. Participants will stand on the device with each foot on a platform and pressure data will be collected as max kg and weigth distribution.
Postural Stability
Time frame: 20 minutes, in the baseline assessment session.
Postural stability assessment will be performed with K-Invent K-Plates device. This device has two separate platforms measuring 320x160 mm. While the participants are on the device with each foot on a platform, bipodal and then unipodal stance data will be collected respectively. Data will be collected three times for 50 seconds for each stance and stability data such as center of pressure, velocity and ellipse area will be recorded. Higher values show poor balance scores.
Foot posture
Time frame: 5 minutes, in the baseline assessment session.
Foot Posture Index will be used to evaluate foot posture. FPI is a six-item clinical assessment tool used to evaluate foot posture. The six criteria used in the evaluation are talar head palpation, supra malleolar and infra malleolar curvature, position of the calcaneal in the frontal plane, protrusion in the talonavicular joint region, compliance of the medial longitudinal arch, and abduction/adduction of the forefoot. Each API component is scored from -2 to +2, with -2 representing clear signs of supination and +2 indicating positive signs of pronation. The total score ranges from -12 to +12. Total scores between 0 and +5 indicate normal/neutral foot posture. Values ≥ +6 are considered pronated foot, while values below 0 are considered supinated foot.
Functionality
Time frame: 3 minutes, in the baseline assessment session.
Functional status will be assessed using Kujala Patellofemoral Pain Form. The questionnare consists of 13 questions. These questions ask whether there is pain during going up and down stairs, squatting, running, jumping and sitting for long periods with the knees flexed; It evaluates whether there is limp, swelling or subluxation of the patella, the amount of atrophy in the quadriceps muscle, flexion deficit and the need for a walking aid. The scoring system ranges from 0-100 points, from worst to best.
2 secondary outcomes
Pain Assessment
Time frame: 1 minute, in the baseline assessment session.
Limb dominance
Time frame: 30 seconds, in the baseline assessment session.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Patellofemoral Pain Syndrome
Recruiting
Effects of Telerehabilitation Versus Supervised Rehabilitation Protocol on Pain, Range of Motion and Functional Recovery in Patients With Patellofemoral Pain Syndrome.
Patello Femoral Pain Syndrome
RecruitingObservational study
MRI Study of Musculoskeletal Function
Abnormalities, Imaging
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruiting
Stabilization vs Corrective Exercise in PFP
Patellofemoral Pain Syndrome
Not yet recruiting
Effectiveness of Selected Traditional Chinese Medicine Topical Agents on Long Distance Runner Versus Exercise Therapy as Control for Patellofemoral Pain Syndrome
Patellar Femoral Syndrome, TCMO (Ng's Prescription)
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.
Hande Guney principal investigator
Hacettepe University Faculty of Physical Therapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellofemoral Pain Syndrome, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 18 Mar 2024. 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 Turkey (Türkiye). 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?
Plantar Pressure (time frame: 3 minutes, in the baseline assessment session.). 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?
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 18 Mar 2024.