Hip Pain ChronicNCT03248934
Patient Performed Examination for Patients With Intra-articular Hip Pain
A study testing Patient Self-Administered Diagnostic Exam and Clinician-Performed Diagnostic Exam in people with Hip Pain Chronic and Hip Disease, run by Duke University at 1 site in United States.
Trial summary
The primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hip Pain Chronic, Hip Disease
- What is being tested?
- Patient Self-Administered Diagnostic Exam and Clinician-Performed Diagnostic Exam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jul 2017to 13 Mar 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years
- Seeking care for hip related pain and/or clicking, catching, giving way or stiffness
- Able to sign or verbalize study consent
- No other medical conditions (e.g. gynecological or urinary pathology) that may affect study results
- English speaking
Who cannot join
- Patients with primary lumbar spine, sacro-iliac or other non-hip related pain as determined with clinical examination
- Previous hip surgery
- Previous hip injury that would normally exclude from examination as standard practice
- Unable to sign or verbalize consent
- Other non-musculoskeletal pathology that may affect study results (e.g. gynecological or urinary pathology)
- Non-English speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Delineating the Concurrent Validity and Diagnostic Accuracy of a Patient Performed Examination for Patients With Intra-Articular Hip Pain: A Proof of Concept Study
The primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test).
- Conditions
- Hip Pain Chronic, Hip Disease
- Being tested
- Patient Self-Administered Diagnostic Exam, Clinician-Performed Diagnostic Exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Self-Administered Diagnostic ExamOther
Participants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants.
Clinician-Performed Diagnostic ExamOther
A clinician-performed diagnostic exam will be completed on the patients.
| Study group | Role | What they receive |
|---|---|---|
| Patient Self-Administered Exam Group | Experimental | Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will first complete a patient self-administered diagnostic exam. Receives: Other: Patient Self-Administered Diagnostic Exam |
| Clinician-Performed Exam Group | Active comparator | Participants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will next complete a clinician-performed diagnostic exam. Receives: Other: Clinician-Performed Diagnostic Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
As measured by a questionnaire evaluating the diagnostic test's ability to identify a positive finding when the targeted diagnosis is actually present (i.e. true positive).
Measured: End of clinician examination, 20 minutes
Secondary outcomes (4)
Specificity
As measured by the discriminatory ability of the diagnostic test to identify if the disease or condition is absent when in actuality it is truly absent (i.e. true negative).
Measured: End of clinician examination, 20 minutes
Diagnostic accuracy measure of positive likelihood ratio
As measured by sensitivity and specificity values.
Measured: End of clinician examination, 20 minutes
Diagnostic accuracy measure of negative likelihood ratio
As measured by sensitivity and specificity values.
Measured: End of clinician examination, 20 minutes
Diagnostic accuracy measure of post-test probabilities
As measured by analysis of the pre-test prevalence of the condition and determination of the post-test shift in probability of the condition.
Measured: End of clinician examination, 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start18 Jul 2017
- Primary completion13 Mar 2018
- Study completion13 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Pain ChronicStudies of the same condition, open and under way.
- More trials run by Duke 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard C. Mather, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248934
- Sponsor's protocol ID
- Pro00082395
- Status last verified
- May 2019
- First submitted
- 10 Aug 2017
- Last updated
- 17 Dec 2019
- 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 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delineating the Concurrent Validity and Diagnostic Accuracy of a Patient Performed Examination for Patients With Intra-Articular Hip Pain: A Proof of Concept Study
- ClinicalTrials.gov ID
- NCT03248934
- Acronym / sponsor ID
- Pro00082395
- Conditions
- Hip Pain Chronic, Hip Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 13 Mar 2018 (actual)
- Study completion
- 13 Mar 2018 (actual)
- First posted
- 15 Aug 2017 (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.
The primary objective of this study is evaluate the diagnostic accuracy of a patient self-administered clinical examination of the hip compared with a traditional clinical examination (i.e. index test).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Self-Administered Exam Group | Experimental | Other: Patient Self-Administered Diagnostic ExamParticipants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will first complete a patient self-administered diagnostic exam. |
| Clinician-Performed Exam Group | Active comparator | Other: Clinician-Performed Diagnostic ExamParticipants with hip pain presenting in the hip preservation clinics will be asked to complete two diagnostic exams. Participants with hip pain will next complete a clinician-performed diagnostic exam. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18-80 years
- Seeking care for hip related pain and/or clicking, catching, giving way or stiffness
- Able to sign or verbalize study consent
- No other medical conditions (e.g. gynecological or urinary pathology) that may affect study results
- English speaking
Key exclusion criteria (6 listed)
- Patients with primary lumbar spine, sacro-iliac or other non-hip related pain as determined with clinical examination
- Previous hip surgery
- Previous hip injury that would normally exclude from examination as standard practice
- Unable to sign or verbalize consent
- Other non-musculoskeletal pathology that may affect study results (e.g. gynecological or urinary pathology)
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 |
|---|---|---|
| Patient Self-Administered Diagnostic ExamParticipants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants. | Other | Patient Self-Administered Exam Group |
| Clinician-Performed Diagnostic ExamA clinician-performed diagnostic exam will be completed on the patients. | Other | Clinician-Performed Exam Group |
Primary outcome
Sensitivity
Time frame: End of clinician examination, 20 minutes
As measured by a questionnaire evaluating the diagnostic test's ability to identify a positive finding when the targeted diagnosis is actually present (i.e. true positive).
4 secondary outcomes
Specificity
Time frame: End of clinician examination, 20 minutes
Diagnostic accuracy measure of positive likelihood ratio
Time frame: End of clinician examination, 20 minutes
Diagnostic accuracy measure of negative likelihood ratio
Time frame: End of clinician examination, 20 minutes
Diagnostic accuracy measure of post-test probabilities
Time frame: End of clinician examination, 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- 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.
Richard C. Mather principal investigator
Duke 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 Patient Self-Administered Diagnostic Exam and Clinician-Performed Diagnostic Exam in people with Hip Pain Chronic and Hip Disease, run by Duke 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 17 Dec 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sensitivity (time frame: End of clinician examination, 20 minutes). 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 17 Dec 2019.