Clinical Decision MakingNEATNCT03519087
Nonarthritic Hip Disease Evaluation And Treatment
A study testing Interdisciplinary Evaluation for Nonarthritic Hip Disease, Posture and Movement Training and Treatment-of-choice in people with Clinical Decision Making and Nonarthritic Hip Disease, run by Ohio State University at 1 site in United States.
Trial summary
The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinical Decision Making, Nonarthritic Hip Disease
- What is being tested?
- Interdisciplinary Evaluation for Nonarthritic Hip Disease, Posture and Movement Training and Treatment-of-choice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2018to 31 May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old NAHD diagnosis
Who cannot join
- Osteoporosis or rheumatoid arthritis
- Systemic health condition
- Legal representative required for treatment decisions
- Bilateral symptoms
- Current spine, hip, knee, or ankle surgery or major injury*
- Pregnancy
Show all 9Show fewer
- Total hip arthroplasty candidate (Tönnis grade > 2)
- Periacetabular osteotomy candidate (lateral center edge angle<20, anterior center edge angle<18, acetabular index >10)
- Participants with history of spine, hip, knee, or ankle surgery or major injury will be evaluated by the physician to determine appropriateness for evaluation (and treatment) by a physical therapist
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
About this study
Official title: Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain
The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. All participants will proceed with their scheduled, standard-care physician evaluation. Participants without NAHD will be excluded. Participants will then be randomized to receive a same-day physical therapist (PT) evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added for research. All participants will complete expectation surveys before and after their evaluation(s). The clinicians will discuss their recommended plan with the patient and the patient will record a final treatment decision and outcome expectations. Participants will then be randomized to either receive posture and movement training (PMT) for 3 weeks or undergo a 3-week wait period. All participants will be required to withhold any treatment during this 3-week period (except PMT in the PMT group). The 3-week wait period for the no-PMT group is aligned with current clinical processes for time from physician evaluation to start of treatment. All participants may proceed with any further interventions (including PMT) after the 3-week period, but none will be provided/required as part of research. Patient-reported outcomes and clinical tests will be recorded before and after the 3-week period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no additional risk because the PT evaluation includes similar clinical tests to the physician and movement analysis during tasks participants complete during daily life. Clinical tests before/after the 3-week intervention period may produce muscle soreness that should resolve within 2 days. Understanding how interdisciplinary care influences expectations and outcomes can inform clinicians regarding the effectiveness of interdisciplinary collaboration.
Read the detailed description
The clinical evaluation by the physician is standard-of-care and performed as part of potential participants' scheduled appointment. Participants in this study will complete a HIPAA authorization to allow data from their clinical evaluation by the physician to be utilized for this study, including any imaging the physician used in their clinical evaluation and the evaluation note entered into the participant's electronic health record. The physician notes are standardized, allowing streamlined data analysis from the electronic health record.
Research activities to occur the same day as the informed consent process include randomization to receive or not receive a clinical evaluation by a physical therapist along with surveys for treatment decisions, expected outcomes, and patient-reported function. A small sub-group of patients will also complete interviews to identify how they felt about their evaluation that day. The HIPAA authorization will also allow the data from the physical therapy evaluation and any subsequent posture and movement training at OSUWMC to be utilized for this study.
Regardless of randomization to receive or not receive a same-day physical therapy evaluation in the physician clinic, all participants will be randomized to receive posture and movement training (PMT) or undergo a 3-week wait period. Participants who are randomized to receive PMT as part of this research study will schedule based on their availability, twice weekly for 3 weeks with an OSUWMC Sports Medicine physical therapist who also hold IRB-approved status as research personnel. Participants will be made aware during the informed consent process that any PMT they receive as part of this study will be their responsibility to pay for using either self-pay or insurance-based methods.
Participants who refuse randomization to receive PMT will be offered to participate in the observational group. These participants proceed with the same baseline and follow-up testing, but continue with their treatment-of-choice rather than an assigned treatment during the 3-week intervention period.
All participants will complete baseline and follow-up biomechanical and clinical follow-up testing in the Motion Analysis and Performance Laboratory. Biomechanical testing involves using 3-dimensional motion capture techniques to analyze movement during 3 functional tasks including walking, sit-to-stand, and a forward tap-down. Clinical testing involves obtaining anthropometric measures, hip strength, patient-reported function, and planned treatment decisions with respective expected outcomes. A small sub-group of patients will also complete interviews at these testing sessions to identify how they feel about the intervention (wait or posture \& movement training).
Posture and movement training involves the physical therapist prescribing therapeutic exercises and activities to improve posture and movement (Harris-Hayes 2016), focusing heavily on extrinsic cueing (Benjaminse 2015). Therapeutic exercises and activities will be individualized based on the participant's presentation and will progress according to pain and quality of movement from double-leg to single-leg activities and from functional to more dynamic tasks.
Participants who are randomized to undergo a 3-week wait period will be required to withhold any treatment during the 3-week wait period. These participants will complete the same testing as the participants in the PMT group (see next paragraph). These participants will not receive any intervention during the 3-week wait period; however, after their first follow-up testing session (within 1 week of completing the 3-week wait period), these participants may proceed with any intervention of their choice. The participants in the PMT group may also proceed with any intervention after their first follow-up testing session. These follow-up interventions will not be provided or required as part of the research study, but participants will be asked to report if they completed any follow-up interventions between their first follow-up testing session and their 3month and 6month follow-up testing sessions.
Follow-up testing will occur within 1-week of completing the 3-week intervention period. At this point, participants in both the PMT and no-PMT groups may proceed with any intervention (i.e. surgery, injection, physical therapy). All participants will perform additional follow-up testing at 3- and 6-months post-intervention.
Qualitative interviews will be conducted to evaluate how physicians and physical therapists involved in the study feel about the evaluation and treatment protocols.
- Conditions
- Clinical Decision Making, Nonarthritic Hip Disease
- Being tested
- Interdisciplinary Evaluation for Nonarthritic Hip Disease, Posture and Movement Training, Treatment-of-choice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interdisciplinary Evaluation for Nonarthritic Hip DiseaseOther
The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.
Posture and Movement TrainingOther
Also called Movement Pattern Training
Physical therapists will lead participants through an intervention protocol to normalize seated and standing posture and function movement. Verbal, visual, and tactile cues, along with strengthening exercises will be provided to train posture and movement.
Treatment-of-choiceOther
Also called Standard care
Participants may proceed with any treatment-of-choice, which may or may not have been recommended by their health care provider(s). Treatments will be recorded, but not controlled.
| Study group | Role | What they receive |
|---|---|---|
| Interdisciplinary Evaluation | Experimental | Participants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. Receives: Other: Interdisciplinary Evaluation for Nonarthritic Hip Disease |
| Standard Evaluation | No intervention | Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant. |
| Posture and Movement Training | Experimental | Participants will receive six training sessions with a physical therapist over a 3-week period. Receives: Other: Posture and Movement Training |
| 3-week Wait Period | No intervention | Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time. |
| Observational Arm | Other | Participants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period. Receives: Other: Treatment-of-choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Plan
Participants will indicate their planned treatment(s)
Measured: Post-evaluation, same-day (approximately 5-10min after evaluation)
Decisional Conflict
Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).
Measured: Pre-evaluation, 10min Post-evaluation
Secondary outcomes (5)
Themes From Provider Interviews
Qualitative interviews will be conducted with study providers both before patient participant enrollment and after study completion to collect information on how they feel about the evaluation protocols. Qualitative analysis of this data will count responses based on themes. Data for this report will be provided as the total number of responses (across all providers) that fell within each theme at both time points. Each provider could provide multiple responses.
Measured: Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)
Participant Protocol Opinions
Participants will be interviewed to collect information on how they feel about the 1) evaluation protocol(s) and 2) treatment/wait period protocols.
Measured: 20min post-evaluation, 4 weeks post-evaluation
Decisional Conflict
Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).
Measured: 10min post-evaluation, 4-week laboratory visit
Patient-reported Hip Function
Participants will complete validated, reliable surveys for hip function (the Hip Outcome Score Activities of Daily Living [HOSADL] was used and is scored from 0-100 with 0 representing the worst function and 100 representing the best function). Baseline scores for participants in Period 3 (Laboratory testing) were obtained from participants' post-evaluation surveys from Period 1 (clinic evaluation).
Measured: 10min post-evaluation, 4-week laboratory visit
Movement Mechanics
3-dimensional movement mechanics will be collected during functional tasks including walking and rising from a chair
Measured: Baseline laboratory visit, 4-week laboratory visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start27 Feb 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: The planned 15-month recruitment period was completed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Clinical Decision MakingStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., Washington University School of Medicine
- Responsible party
- Principal investigator, Stephanie Di Stasi, Ohio State University
- Investigators
- Stephanie Di Stasi, PhD, PT, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519087
- Sponsor's protocol ID
- 2017H0340
- Acronym
- NEAT
- Status last verified
- May 2020
- First submitted
- 27 Mar 2018
- Last updated
- 6 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, our IPD will be shared with researchers listed on the funding mechanisms for this project. When submitting manuscripts, IPD will be available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informed Decisions and Patient Outcomes: An Interdisciplinary Approach to Chronic Hip Pain
- ClinicalTrials.gov ID
- NCT03519087
- Acronym / sponsor ID
- NEAT / 2017H0340
- Conditions
- Clinical Decision Making, Nonarthritic Hip Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The planned 15-month recruitment period was completed.
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., Washington University School of Medicine
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Posted 6 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to understand how interdisciplinary care influences decisions, expectations, and outcomes for patients with non-arthritic hip disease (NAHD). Patients presenting to the Ohio State University Wexner Medical Center (OSUWMC) Hip Preservation Clinic will be approached for participation. All participants will proceed with their scheduled, standard-care physician evaluation. Participants without NAHD will be excluded. Participants will then be randomized to receive a same-day physical therapist (PT) evaluation. This PT evaluation is not a standard-care practice in the clinic, this was added for research. All participants will complete expectation surveys before and after their evaluation(s). The clinicians will discuss their recommended plan with the patient and the patient will record a final treatment decision and outcome expectations. Participants will then be randomized to either receive posture and movement training (PMT) for 3 weeks or undergo a 3-week wait period. All participants will be required to withhold any treatment during this 3-week period (except PMT in the PMT group). The 3-week wait period for the no-PMT group is aligned with current clinical processes for time from physician evaluation to start of treatment. All participants may proceed with any further interventions (including PMT) after the 3-week period, but none will be provided/required as part of research. Patient-reported outcomes and clinical tests will be recorded before and after the 3-week period, and 3 and 6 months later. Adding a PT evaluation to the physician visit provides no additional risk because the PT evaluation includes similar clinical tests to the physician and movement analysis during tasks participants complete during daily life. Clinical tests before/after the 3-week intervention period may produce muscle soreness that should resolve within 2 days. Understanding how interdisciplinary care influences expectations and outcomes can inform clinicians regarding the effectiveness of interdisciplinary collaboration.
Detailed description
The clinical evaluation by the physician is standard-of-care and performed as part of potential participants' scheduled appointment. Participants in this study will complete a HIPAA authorization to allow data from their clinical evaluation by the physician to be utilized for this study, including any imaging the physician used in their clinical evaluation and the evaluation note entered into the participant's electronic health record. The physician notes are standardized, allowing streamlined data analysis from the electronic health record.
Research activities to occur the same day as the informed consent process include randomization to receive or not receive a clinical evaluation by a physical therapist along with surveys for treatment decisions, expected outcomes, and patient-reported function. A small sub-group of patients will also complete interviews to identify how they felt about their evaluation that day. The HIPAA authorization will also allow the data from the physical therapy evaluation and any subsequent posture and movement training at OSUWMC to be utilized for this study.
Regardless of randomization to receive or not receive a same-day physical therapy evaluation in the physician clinic, all participants will be randomized to receive posture and movement training (PMT) or undergo a 3-week wait period. Participants who are randomized to receive PMT as part of this research study will schedule based on their availability, twice weekly for 3 weeks with an OSUWMC Sports Medicine physical therapist who also hold IRB-approved status as research personnel. Participants will be made aware during the informed consent process that any PMT they receive as part of this study will be their responsibility to pay for using either self-pay or insurance-based methods.
Participants who refuse randomization to receive PMT will be offered to participate in the observational group. These participants proceed with the same baseline and follow-up testing, but continue with their treatment-of-choice rather than an assigned treatment during the 3-week intervention period.
All participants will complete baseline and follow-up biomechanical and clinical follow-up testing in the Motion Analysis and Performance Laboratory. Biomechanical testing involves using 3-dimensional motion capture techniques to analyze movement during 3 functional tasks including walking, sit-to-stand, and a forward tap-down. Clinical testing involves obtaining anthropometric measures, hip strength, patient-reported function, and planned treatment decisions with respective expected outcomes. A small sub-group of patients will also complete interviews at these testing sessions to identify how they feel about the intervention (wait or posture \& movement training).
Posture and movement training involves the physical therapist prescribing therapeutic exercises and activities to improve posture and movement (Harris-Hayes 2016), focusing heavily on extrinsic cueing (Benjaminse 2015). Therapeutic exercises and activities will be individualized based on the participant's presentation and will progress according to pain and quality of movement from double-leg to single-leg activities and from functional to more dynamic tasks.
Participants who are randomized to undergo a 3-week wait period will be required to withhold any treatment during the 3-week wait period. These participants will complete the same testing as the participants in the PMT group (see next paragraph). These participants will not receive any intervention during the 3-week wait period; however, after their first follow-up testing session (within 1 week of completing the 3-week wait period), these participants may proceed with any intervention of their choice. The participants in the PMT group may also proceed with any intervention after their first follow-up testing session. These follow-up interventions will not be provided or required as part of the research study, but participants will be asked to report if they completed any follow-up interventions between their first follow-up testing session and their 3month and 6month follow-up testing sessions.
Follow-up testing will occur within 1-week of completing the 3-week intervention period. At this point, participants in both the PMT and no-PMT groups may proceed with any intervention (i.e. surgery, injection, physical therapy). All participants will perform additional follow-up testing at 3- and 6-months post-intervention.
Qualitative interviews will be conducted to evaluate how physicians and physical therapists involved in the study feel about the evaluation and treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Interdisciplinary Evaluation | Experimental | Other: Interdisciplinary Evaluation for Nonarthritic Hip DiseaseParticipants will receive an Interdisciplinary Evaluation for Nonarthritic Hip Disease from a hip arthroscopist, followed by an examination from a physical therapist, and then will participate in a shared decision-making process with both providers to determine a plan of care. |
| Standard Evaluation | No intervention | –Participants will receive a standard-of-care evaluation from a hip arthroscopist who will then determine the plan of care with the participant. |
| Posture and Movement Training | Experimental | Other: Posture and Movement TrainingParticipants will receive six training sessions with a physical therapist over a 3-week period. |
| 3-week Wait Period | No intervention | –Participants will undergo a 3-week wait period. They will be instructed to not receive any treatment (e.g. chiropractic services, physical therapy, medication, surgery, injections) for their hip symptoms during this time. |
| Observational Arm | Other | Other: Treatment-of-choiceParticipants who refuse randomization to receive posture and movement training may continue participation in an observational group. These participants complete the same baseline and follow-up testing but proceed with their treatment-of-choice during the 3-week intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Over 18 years old NAHD diagnosis
Key exclusion criteria (9 listed)
- Osteoporosis or rheumatoid arthritis
- Systemic health condition
- Legal representative required for treatment decisions
- Bilateral symptoms
- Current spine, hip, knee, or ankle surgery or major injury*
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 |
|---|---|---|
| Interdisciplinary Evaluation for Nonarthritic Hip DiseaseThe hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant. | Other | Interdisciplinary Evaluation |
| Posture and Movement TrainingAlso: Movement Pattern TrainingPhysical therapists will lead participants through an intervention protocol to normalize seated and standing posture and function movement. Verbal, visual, and tactile cues, along with strengthening exercises will be provided to train posture and movement. | Other | Posture and Movement Training |
| Treatment-of-choiceAlso: Standard careParticipants may proceed with any treatment-of-choice, which may or may not have been recommended by their health care provider(s). Treatments will be recorded, but not controlled. | Other | Observational Arm |
Primary outcome
Treatment Plan
Time frame: Post-evaluation, same-day (approximately 5-10min after evaluation)
Participants will indicate their planned treatment(s)
Decisional Conflict
Time frame: Pre-evaluation, 10min Post-evaluation
Participants will report decisional conflict related to their treatment plan. Decisional conflict was measured using the Decisional Conflict Scale ranging from 0 (no conflict, better outcome) to 100 (high conflict, worse outcome).
5 secondary outcomes
Themes From Provider Interviews
Time frame: Pre-enrollment (2-7days before patient participant recruitment began), Post-enrollment (1-7 days after patient participant recruitment ended)
Participant Protocol Opinions
Time frame: 20min post-evaluation, 4 weeks post-evaluation
Decisional Conflict
Time frame: 10min post-evaluation, 4-week laboratory visit
Patient-reported Hip Function
Time frame: 10min post-evaluation, 4-week laboratory visit
Movement Mechanics
Time frame: Baseline laboratory visit, 4-week laboratory visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. At this time, our IPD will be shared with researchers listed on the funding mechanisms for this project. When submitting manuscripts, IPD will be available upon request.
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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.
Stephanie Di Stasi, PhD, PT principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interdisciplinary Evaluation for Nonarthritic Hip Disease, Posture and Movement Training and Treatment-of-choice in people with Clinical Decision Making and Nonarthritic Hip Disease, run by Ohio State University 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 1 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 May 2020. 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. 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?
Yes. Results are posted in the registry (first posted 6 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Plan (time frame: Post-evaluation, same-day (approximately 5-10min after evaluation)). The study lists 2 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 6 May 2020.