Knee PainNCT01492244
Validation of an Online Knee Pain Map and Questionnaire: A Probabilistic Diagnostic Tool
An observational study of Knee Pain, run by Brock Foster at 1 site in United States.
Trial summary
"Blank" has designed a medical diagnostic system in the form of an unvalidated online questionnaire and drawing tool used to describe and identify the location of knee pain, respectively. A component of the survey includes the patient inputting their diagnosis as the etiology of their knee pain. Dr. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to not given
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients older than 18 years old with knee pain that contains a known diagnosis for their pain.
Who may be able to join
- patients with knee pain and a known diagnosis for their pain
- patients older than 18 years old
Who cannot join
- patients that are unable or unwilling to complete the online survey.
- patients who do not have a diagnosis for their knee pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alidation of an Online Knee Pain Map and Questionnaire: A Probabilistic Diagnostic Tool
"Blank" has designed a medical diagnostic system in the form of an unvalidated online questionnaire and drawing tool used to describe and identify the location of knee pain, respectively. A component of the survey includes the patient inputting their diagnosis as the etiology of their knee pain. Dr. Ivo Dinov's team has used the data from 100,000 patient surveys to construct a probabilistic model to diagnose those who fill out the questionnaire and knee pain map but do not have a diagnosis. However, the validity of the online survey and the accuracy of the probabilistic model has not been confirmed in patients with known diagnoses. Therefore, the purpose of this study will be to recruit patients with knee pain at UCLA orthopedic clinics to complete the online survey which will then be applied to the probabilistic model to output possible diagnoses. The results will be compared to the actual diagnosis assigned to that patient in the clinic. If validated, the online survey may serve as a tool for diagnostic and research purposes.
- Conditions
- Knee Pain
- Keywords
- Knee pain, map, questionnaire, survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee pain and a known diagnosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability of the UCLA modeling software to predict diagnosis based on questionnaire answers
UCLA has developed modeling software that may be accurate at predicting diagnoses depending on the answers given by patients to an online questionnaire and knee pain drawing map. The accuracy of the software has not been tested or validated. This study will determine the accuracy of this software by comparing UCLA orthopedic surgeon input diagnosis to that output by the modeling software following completion of the questionnaire by study participants.
Measured: One year
Secondary outcomes (1)
Accuracy of patient input diagnosis compared to orthopedic surgeon diagnosis
Patients may inaccurately input "known diagnoses" into the online questionnaire because they were diagnosed inaccurately by their doctor, input the wrong diagnosis into the questionnaire by accident, or were never diagnosed with a condition but they input a diagnosis. Therefore, because the modeling software is contingent on accurate patient input diagnoses, determining if patients accurately input their diagnoses into the questionnaire by comparing surgeon input diagnosis to patient input diagnosis may be helpful in elucidating modeling inaccuracy.
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee PainStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brock Foster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Brock Foster, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492244
- Sponsor's protocol ID
- 11-003024
- Status last verified
- Mar 2012
- First submitted
- 6 Dec 2011
- Last updated
- 27 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alidation of an Online Knee Pain Map and Questionnaire: A Probabilistic Diagnostic Tool
- ClinicalTrials.gov ID
- NCT01492244
- Acronym / sponsor ID
- 11-003024
- Conditions
- Knee Pain
- Keywords
- Knee pain, map, questionnaire, survey
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Brock FosterUniversity, hospital or other
- Study start
- Dec 2011
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"Blank" has designed a medical diagnostic system in the form of an unvalidated online questionnaire and drawing tool used to describe and identify the location of knee pain, respectively. A component of the survey includes the patient inputting their diagnosis as the etiology of their knee pain. Dr. Ivo Dinov's team has used the data from 100,000 patient surveys to construct a probabilistic model to diagnose those who fill out the questionnaire and knee pain map but do not have a diagnosis. However, the validity of the online survey and the accuracy of the probabilistic model has not been confirmed in patients with known diagnoses. Therefore, the purpose of this study will be to recruit patients with knee pain at UCLA orthopedic clinics to complete the online survey which will then be applied to the probabilistic model to output possible diagnoses. The results will be compared to the actual diagnosis assigned to that patient in the clinic. If validated, the online survey may serve as a tool for diagnostic and research purposes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee pain and a known diagnosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients older than 18 years old with knee pain that contains a known diagnosis for their pain.
Key inclusion criteria (2 listed)
- patients with knee pain and a known diagnosis for their pain
- patients older than 18 years old
Key exclusion criteria (2 listed)
- patients that are unable or unwilling to complete the online survey.
- patients who do not have a diagnosis for their knee pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The ability of the UCLA modeling software to predict diagnosis based on questionnaire answers
Time frame: One year
UCLA has developed modeling software that may be accurate at predicting diagnoses depending on the answers given by patients to an online questionnaire and knee pain drawing map. The accuracy of the software has not been tested or validated. This study will determine the accuracy of this software by comparing UCLA orthopedic surgeon input diagnosis to that output by the modeling software following completion of the questionnaire by study participants.
1 secondary outcome
Accuracy of patient input diagnosis compared to orthopedic surgeon diagnosis
Time frame: One Year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Pain, run by Brock Foster 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2012. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ability of the UCLA modeling software to predict diagnosis based on questionnaire answers (time frame: One year). 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 27 Mar 2012.