Muscle Atrophy, ProximalNCT04105816
Ultrasound for Rectus Femoris Measurement
A study testing 892.1550 Ultrasonic pulsed doppler imaging system and Thigh circumference measurement in people with Muscle Atrophy, Proximal and Muscle Atrophy, run by Robert Westermann at 1 site in United States.
Trial summary
Postoperative protocols for orthopedic procedures on the lower limb often require a period of immobilization to protect the surgical site. The consequence of this immobilization is muscle atrophy which can be severe, delaying a patient's return to activity and predisposing them to recovery complications or subsequent… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Atrophy, Proximal, Muscle Atrophy, ACL Tear
- What is being tested?
- 892.1550 Ultrasonic pulsed doppler imaging system and Thigh circumference measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2020to 31 Dec 2021
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults with no known musculoskeletal injury
- -Adult volunteers undergoing anterior cruciate ligament reconstruction at the University of Iowa
Who cannot join
- Those with identified musculoskeletal injury
- Non-English speaking persons
- Women who are pregnant. Graduate medical education residents will be from the
- Part 2 -
- non-English speaking persons
- women who are pregnant
Show all 10Show fewer
- patients undergoing multi-ligament repair
- patients undergoing ACL reconstruction revision
- patients undergoing concomitant cartilage or meniscal repair procedure
- patients undergoing bilateral ACL reconstructions
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Sports Medicine
Iowa City, Iowa, 52246
About this study
Official title: Assessing the Reliability and Validity of Ultrasound to Evaluate Large Muscle Atrophy in the Lower Limbs
Postoperative protocols for orthopedic procedures on the lower limb often require a period of immobilization to protect the surgical site. The consequence of this immobilization is muscle atrophy which can be severe, delaying a patient's return to activity and predisposing them to recovery complications or subsequent injury (1)(2).
The current standard methods to assess lower limb muscle atrophy all have their respective limitations. Thigh circumference or isokinetic strength values are indirect measures of atrophy and can be inaccurate. Magnetic resonance imaging (MRI) of muscle cross-sectional area (CSA) is time-consuming and expensive. Computed tomography imaging of muscle CSA is expensive and exposes the patient to radiation (3). For these reasons, none of the current methods are ideal for regular use in the clinic.
Musculoskeletal ultrasound is a promising measurement tool to assess muscle atrophy in postoperative patients. Ultrasound is non-invasive, cost-effective, does not involve radiation, and can give direct images of muscle size (4). Musculoskeletal ultrasound requires further research on its potential as an evaluation tool for postoperative lower limb orthopedic patients-specifically, whether ultrasound is a reliable and valid tool for quadriceps size measurements.
Read the detailed description
Lower limb surgeries, particularly knee surgeries, are prevalent procedures in US orthopedic departments. Many of these procedures require a postoperative period of immobilization, which may be lengthy for surgeries involving ligament reconstruction, fractures, meniscal repairs, or cartilage transplantation. This leg immobilization results in rapid and significant loss of skeletal muscle mass. Even for shorter periods of immobilization, atrophy occurs within as little as 5 days of immobilization in healthy subjects, and the largest extent of post-operative atrophy takes place during the first two weeks of being immobilized (1)(2).
Muscle atrophy can prolong recovery times and directly impact the safety of a patient's return to activity progression. Providers need a reliable, valid method of assessing postoperative muscle atrophy which is cost-effective, safe, and simple to implement in a clinical setting (4). The aim of this study is to demonstrate that ultrasounds are reliable and valid tools for measuring large lower limb stabilizers such as the rectus femoris. Upon proving reliability and validity, we aim to use the ultrasound to track and characterize rectus femoris atrophy after a common lower limb surgical procedure; anterior cruciate ligament (ACL) reconstruction. Success of this validation study would support the use of ultrasound to monitor large muscle atrophy after lower limb orthopedic surgical procedures, and to evaluate the impact of muscle health interventions. Our ultimate research aim is to develop a reliable, valid ultrasound measurement technique to evaluate promising perioperative interventions for attenuation of muscle atrophy following surgical procedures of the knee.
Patients and Methods:
Part I: Ultrasound measurements of the rectus femoris will be obtained in approximately 50 healthy volunteers. Thigh circumference measurements will be taken as well. The ultrasound (US) images will be de-identified with research identifier (ID) only and transferred from the US unit to a secured folder on a research drive, and associated only with basic demographic information such as age, gender, height, and weight. Ultrasounds currently in use at the UIHC Sports Medicine Clinic will be used. Measurements will be made at a point mid-way between the anterior superior iliac spine and the superior border of the patella.
Part II: Following validation in healthy controls, approximately 100 ACL reconstruction patients will be enrolled for a longitudinal study which utilizes the same ultrasound methods and equipment to track their rectus femoris size at a preoperative visit, and during the 6 week, 3 month, and 6 month standard postoperative follow-up visits. Thigh circumference measurements will be taken as well. The ultrasound images will be de-identified with research ID only and transferred from the US unit to a secured folder on a research drive, and associated only with basic demographic information such as age, gender, height, and weight; along with basic survey data on physical therapy adherence. The patients will not incur any cost from the ultrasound testing, and the ultrasound testing will occur at the same clinical location (UIHC Sports Medicine Clinic) as their follow-up visits.
Aim 1: Assess the inter-rater and intra-rater reliability of ultrasound for measuring skeletal size using a commercially available ultrasound unit.
Hypothesis 1: We hypothesize that ultrasound measures of rectus femoris will demonstrate both high intrarater and interrater reliability.
Aim 2: Assess the validity of ultrasound in measuring muscle size when utilized by a novice user as compared to a professional sonographer.
Hypothesis 2. The ultrasound will demonstrate high validity and ease of use when comparing novice and professionally obtained images.
Aim 3: Assess the accuracy of ultrasound in measuring muscle size compared to the literature standard measurement technique of thigh circumference.
Hypothesis 3: Ultrasound measurements will be equally or more accurate than thigh circumference measurements at detecting rectus femoris size differences between subjects, and ultrasound measurements will have less interrater and intrarater variability.
Aim 4: Develop a descriptive characterization of rectus femoris size parameters among a healthy young adult population.
Aim 5: Track and characterize rectus femoris atrophy in ACL reconstruction patients using the validated ultrasound methodology.
Hypothesis 4: Patients will show a statistically significant degree of rectus femoris atrophy between their preoperative visit measurement and their 6 week and 3 month follow up measurements.
Hypothesis 5: Patients will show a statistically significant degree of improvement in rectus femoris atrophy when comparing their 6 month visit measurements with their 6 week and 3 month visit measurements.
Hypothesis 6: There will not be a significant difference between the preoperative and 6 month postoperative rectus femoris measurements.
Hypothesis 7: Ultrasounds measurements will be equally or more sensitive at detecting significant rectus femoris atrophy in anterior cruciate ligament reconstruction (ACLR) patients compared to thigh circumference measurements.
Aim 6: Analyze how external factors impact rectus femoris atrophy in ACL reconstruction patients using the validated ultrasound methodology Hypothesis 8: Graft choice will impact rectus femoris atrophy and recovery. Hypothesis 9: Fewer physical therapy office visits will impact rectus femoris atrophy and recovery.
- Being tested
- 892.1550 Ultrasonic pulsed doppler imaging system, Thigh circumference measurement
- Keywords
- rectus femoris, ACL repair recovery, musculoskeletal ultrasound, quadriceps atrophy, validation
- Medical subject headings
- Muscular Atrophy, Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
892.1550 Ultrasonic pulsed doppler imaging systemDevice
Use of the ultrasound to measure quadriceps volume
Thigh circumference measurementDiagnostic test
Tape measure used to measure thigh circumference of all participating patients in the study at the same visit in which they receive ultrasound measurements of thigh muscles.
| Study group | Role | What they receive |
|---|---|---|
| Adult Healthy Controls | Placebo comparator | Subjects included in part I of this study will be healthy adult volunteers with no known musculoskeletal injury. Exclusion criteria will be those with identified musculoskeletal injury, non-English speaking persons, and women who are pregnant. Receives: Device: 892.1550 Ultrasonic pulsed doppler imaging system; Diagnostic Test: Thigh circumference measurement |
| Adult ACL Reconstruction Patients | Experimental | Subjects included in part II of the study will be adult volunteers undergoing anterior cruciate ligament reconstruction at the University of Iowa. Exclusion criteria will be non-English speaking persons, women who are pregnant, patients undergoing multi-ligament repair, patients undergoing ACL reconstruction revision, patients undergoing concomitant cartilage or meniscal repair procedures, and patients undergoing bilateral ACL reconstructions. Receives: Device: 892.1550 Ultrasonic pulsed doppler imaging system; Diagnostic Test: Thigh circumference measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity of musculoskeletal ultrasound use
Intra- and inter-rater validity compared to thigh circumference measurements. For inter-rater, intra-rater , and the comparison between professional and novice users, for muscle cross sectional area/thickness, we will use inter-rater correlation coefficient (ICC), kappa statistic, and Bland-Altman plot analysis. These analyses will help us determine validity of the ultrasound measuring device. Measurements of the contralateral limb will be used as internal controls. Due to the nature of this study, a power analysis is not needed, since it is a validity/characterization study and we are not looking to find a specific difference between the two types of users.
Measured: 2 weeks
Reliability of musculoskeletal ultrasound use
Intra- and inter-rater reliability, reliability compared to thigh circumference measurements. For inter-rater, intra-rater reliability, and the comparison between professional and novice users, for muscle cross sectional area/thickness, we will use inter-rater correlation coefficient (ICC), kappa statistic, and Bland-Altman plot analysis. These analyses will help us determine reliability of the ultrasound measuring device and the measuring technique between individual users and between measurements by the same individual. Measurements of the contralateral limb will be used as internal controls. Due to the nature of this study, a power analysis is not needed, since it is a validity/characterization study and we are not looking to find a specific difference between the two types of users.
Measured: 2 weeks
Amount of quadriceps atrophy using musculoskeletal ultrasound following anterior cruciate ligament reconstruction
Change in the operative leg versus non-operative leg muscle cross sectional area/thickness will be determined. The degree of change in the operative leg versus the non-operative leg will be evaluated for significant differences. The total number of patients with significant differences between their operative and non-operative legs will be recorded for each time point in the study. The mean and median amount of change at each time point in the operative leg versus the non-operative leg will constitute the "amount of quadriceps atrophy" outcome.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Dec 2020 (estimated)
- Primary completion1 Mar 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Why it stopped: COVID19 continually delayed in-person research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Atrophy, ProximalStudies 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Robert Westermann
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Robert Westermann, University of Iowa
- Investigators
- Robert Westermann, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105816
- Sponsor's protocol ID
- 201906778
- Status last verified
- Feb 2023
- First submitted
- 22 Sep 2019
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Reliability and Validity of Ultrasound to Evaluate Large Muscle Atrophy in the Lower Limbs
- ClinicalTrials.gov ID
- NCT04105816
- Acronym / sponsor ID
- 201906778
- Keywords
- rectus femoris, ACL repair recovery, musculoskeletal ultrasound, quadriceps atrophy, validation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID19 continually delayed in-person research
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Robert WestermannUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Sep 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.
Postoperative protocols for orthopedic procedures on the lower limb often require a period of immobilization to protect the surgical site. The consequence of this immobilization is muscle atrophy which can be severe, delaying a patient's return to activity and predisposing them to recovery complications or subsequent injury (1)(2).
The current standard methods to assess lower limb muscle atrophy all have their respective limitations. Thigh circumference or isokinetic strength values are indirect measures of atrophy and can be inaccurate. Magnetic resonance imaging (MRI) of muscle cross-sectional area (CSA) is time-consuming and expensive. Computed tomography imaging of muscle CSA is expensive and exposes the patient to radiation (3). For these reasons, none of the current methods are ideal for regular use in the clinic.
Musculoskeletal ultrasound is a promising measurement tool to assess muscle atrophy in postoperative patients. Ultrasound is non-invasive, cost-effective, does not involve radiation, and can give direct images of muscle size (4). Musculoskeletal ultrasound requires further research on its potential as an evaluation tool for postoperative lower limb orthopedic patients-specifically, whether ultrasound is a reliable and valid tool for quadriceps size measurements.
Detailed description
Lower limb surgeries, particularly knee surgeries, are prevalent procedures in US orthopedic departments. Many of these procedures require a postoperative period of immobilization, which may be lengthy for surgeries involving ligament reconstruction, fractures, meniscal repairs, or cartilage transplantation. This leg immobilization results in rapid and significant loss of skeletal muscle mass. Even for shorter periods of immobilization, atrophy occurs within as little as 5 days of immobilization in healthy subjects, and the largest extent of post-operative atrophy takes place during the first two weeks of being immobilized (1)(2).
Muscle atrophy can prolong recovery times and directly impact the safety of a patient's return to activity progression. Providers need a reliable, valid method of assessing postoperative muscle atrophy which is cost-effective, safe, and simple to implement in a clinical setting (4). The aim of this study is to demonstrate that ultrasounds are reliable and valid tools for measuring large lower limb stabilizers such as the rectus femoris. Upon proving reliability and validity, we aim to use the ultrasound to track and characterize rectus femoris atrophy after a common lower limb surgical procedure; anterior cruciate ligament (ACL) reconstruction. Success of this validation study would support the use of ultrasound to monitor large muscle atrophy after lower limb orthopedic surgical procedures, and to evaluate the impact of muscle health interventions. Our ultimate research aim is to develop a reliable, valid ultrasound measurement technique to evaluate promising perioperative interventions for attenuation of muscle atrophy following surgical procedures of the knee.
Patients and Methods:
Part I: Ultrasound measurements of the rectus femoris will be obtained in approximately 50 healthy volunteers. Thigh circumference measurements will be taken as well. The ultrasound (US) images will be de-identified with research identifier (ID) only and transferred from the US unit to a secured folder on a research drive, and associated only with basic demographic information such as age, gender, height, and weight. Ultrasounds currently in use at the UIHC Sports Medicine Clinic will be used. Measurements will be made at a point mid-way between the anterior superior iliac spine and the superior border of the patella.
Part II: Following validation in healthy controls, approximately 100 ACL reconstruction patients will be enrolled for a longitudinal study which utilizes the same ultrasound methods and equipment to track their rectus femoris size at a preoperative visit, and during the 6 week, 3 month, and 6 month standard postoperative follow-up visits. Thigh circumference measurements will be taken as well. The ultrasound images will be de-identified with research ID only and transferred from the US unit to a secured folder on a research drive, and associated only with basic demographic information such as age, gender, height, and weight; along with basic survey data on physical therapy adherence. The patients will not incur any cost from the ultrasound testing, and the ultrasound testing will occur at the same clinical location (UIHC Sports Medicine Clinic) as their follow-up visits.
Aim 1: Assess the inter-rater and intra-rater reliability of ultrasound for measuring skeletal size using a commercially available ultrasound unit.
Hypothesis 1: We hypothesize that ultrasound measures of rectus femoris will demonstrate both high intrarater and interrater reliability.
Aim 2: Assess the validity of ultrasound in measuring muscle size when utilized by a novice user as compared to a professional sonographer.
Hypothesis 2. The ultrasound will demonstrate high validity and ease of use when comparing novice and professionally obtained images.
Aim 3: Assess the accuracy of ultrasound in measuring muscle size compared to the literature standard measurement technique of thigh circumference.
Hypothesis 3: Ultrasound measurements will be equally or more accurate than thigh circumference measurements at detecting rectus femoris size differences between subjects, and ultrasound measurements will have less interrater and intrarater variability.
Aim 4: Develop a descriptive characterization of rectus femoris size parameters among a healthy young adult population.
Aim 5: Track and characterize rectus femoris atrophy in ACL reconstruction patients using the validated ultrasound methodology.
Hypothesis 4: Patients will show a statistically significant degree of rectus femoris atrophy between their preoperative visit measurement and their 6 week and 3 month follow up measurements.
Hypothesis 5: Patients will show a statistically significant degree of improvement in rectus femoris atrophy when comparing their 6 month visit measurements with their 6 week and 3 month visit measurements.
Hypothesis 6: There will not be a significant difference between the preoperative and 6 month postoperative rectus femoris measurements.
Hypothesis 7: Ultrasounds measurements will be equally or more sensitive at detecting significant rectus femoris atrophy in anterior cruciate ligament reconstruction (ACLR) patients compared to thigh circumference measurements.
Aim 6: Analyze how external factors impact rectus femoris atrophy in ACL reconstruction patients using the validated ultrasound methodology Hypothesis 8: Graft choice will impact rectus femoris atrophy and recovery. Hypothesis 9: Fewer physical therapy office visits will impact rectus femoris atrophy and recovery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult Healthy Controls | Placebo comparator | Device: 892.1550 Ultrasonic pulsed doppler imaging system, Diagnostic Test: Thigh circumference measurementSubjects included in part I of this study will be healthy adult volunteers with no known musculoskeletal injury. Exclusion criteria will be those with identified musculoskeletal injury, non-English speaking persons, and women who are pregnant. |
| Adult ACL Reconstruction Patients | Experimental | Device: 892.1550 Ultrasonic pulsed doppler imaging system, Diagnostic Test: Thigh circumference measurementSubjects included in part II of the study will be adult volunteers undergoing anterior cruciate ligament reconstruction at the University of Iowa. Exclusion criteria will be non-English speaking persons, women who are pregnant, patients undergoing multi-ligament repair, patients undergoing ACL reconstruction revision, patients undergoing concomitant cartilage or meniscal repair procedures, and patients undergoing bilateral ACL reconstructions. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults with no known musculoskeletal injury
- -Adult volunteers undergoing anterior cruciate ligament reconstruction at the University of Iowa
Key exclusion criteria (10 listed)
- Those with identified musculoskeletal injury
- Non-English speaking persons
- Women who are pregnant. Graduate medical education residents will be from the
- Part 2 -
- non-English speaking persons
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 |
|---|---|---|
| 892.1550 Ultrasonic pulsed doppler imaging systemUse of the ultrasound to measure quadriceps volume | Device | Adult ACL Reconstruction Patients, Adult Healthy Controls |
| Thigh circumference measurementTape measure used to measure thigh circumference of all participating patients in the study at the same visit in which they receive ultrasound measurements of thigh muscles. | Diagnostic test | Adult ACL Reconstruction Patients, Adult Healthy Controls |
Primary outcome
Validity of musculoskeletal ultrasound use
Time frame: 2 weeks
Intra- and inter-rater validity compared to thigh circumference measurements. For inter-rater, intra-rater , and the comparison between professional and novice users, for muscle cross sectional area/thickness, we will use inter-rater correlation coefficient (ICC), kappa statistic, and Bland-Altman plot analysis. These analyses will help us determine validity of the ultrasound measuring device. Measurements of the contralateral limb will be used as internal controls. Due to the nature of this study, a power analysis is not needed, since it is a validity/characterization study and we are not looking to find a specific difference between the two types of users.
Reliability of musculoskeletal ultrasound use
Time frame: 2 weeks
Intra- and inter-rater reliability, reliability compared to thigh circumference measurements. For inter-rater, intra-rater reliability, and the comparison between professional and novice users, for muscle cross sectional area/thickness, we will use inter-rater correlation coefficient (ICC), kappa statistic, and Bland-Altman plot analysis. These analyses will help us determine reliability of the ultrasound measuring device and the measuring technique between individual users and between measurements by the same individual. Measurements of the contralateral limb will be used as internal controls. Due to the nature of this study, a power analysis is not needed, since it is a validity/characterization study and we are not looking to find a specific difference between the two types of users.
Amount of quadriceps atrophy using musculoskeletal ultrasound following anterior cruciate ligament reconstruction
Time frame: 6 months
Change in the operative leg versus non-operative leg muscle cross sectional area/thickness will be determined. The degree of change in the operative leg versus the non-operative leg will be evaluated for significant differences. The total number of patients with significant differences between their operative and non-operative legs will be recorded for each time point in the study. The mean and median amount of change at each time point in the operative leg versus the non-operative leg will constitute the "amount of quadriceps atrophy" outcome.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- 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.
Robert Westermann, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 892.1550 Ultrasonic pulsed doppler imaging system and Thigh circumference measurement in people with Muscle Atrophy, Proximal and Muscle Atrophy, run by Robert Westermann at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 21 Feb 2023. 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 United States. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Validity of musculoskeletal ultrasound use (time frame: 2 weeks). The study lists 3 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 21 Feb 2023.