Sacroiliac InjectionNCT01875406
a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram
A study testing diagnostic exercises in people with Sacroiliac Injection, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the predictive value of a composite of 3 simple clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sacroiliac Injection
- What is being tested?
- diagnostic exercises
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Apr 2016
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any patient presenting with low back pain with or without radicular symptoms, regardless of prior history of back surgery from 18-90 years old whom after being evaluated by an independent clinician in the Cleveland Clinic pain clinic has been scheduled for a diagnostic SIJ injection.
Who cannot join
- any patient less than 18 or greater than 90 years old, has any medical condition that would not allow them to complete the study, diagnosis of any recent fractures in the lumbar spine, recent infection, pregnancy, taking anticoagulants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnosis of Sacroiliac Joint Pain: Predictive Value of a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram
The purpose of this study is to determine the predictive value of a composite of 3 simple clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection.
Read the detailed description
The purpose of this study is to determine the predictive value of a composite of 3 simple, clinically practical, diagnostic tests (Mekhail, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection. The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of SIJ mediated pain. . Specifically, we seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately predict the response (change in VAS) of a single diagnostic Sacroiliac joint and extra-capsular joint injection.
- Conditions
- Sacroiliac Injection
- Being tested
- diagnostic exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic exercisesOther
Also called questionnaires, pain surveys
| Study group | Role | What they receive |
|---|---|---|
| diagnostic exercises | Experimental | The three diagnostic exercises will be administered in random order to minimize effects of order and period on the results. Enrollment logs and study randomization will be administered electronically via a respective REDCap data modules. The enrollment, randomization and diagnostic tests will be administered by research coordinator or PI. The patients will be independently evaluated and scheduled for SIJ injection by Cleveland Clinic pain clinic staff and fellow pain physicians. Receives: Other: diagnostic exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
validity of assessments
The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of Sacroiliac joint (SIJ) mediated pain.
Measured: Day 1
Secondary outcomes (1)
prognostic assessment
Specifically, we seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately predict the response of a single diagnostic Sacroiliac joint and extra-capsular joint injection.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac InjectionStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maged Guirguis, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01875406
- Sponsor's protocol ID
- 13-416
- Status last verified
- Apr 2017
- First submitted
- 5 Jun 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Sacroiliac Joint Pain: Predictive Value of a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram
- ClinicalTrials.gov ID
- NCT01875406
- Acronym / sponsor ID
- 13-416
- Conditions
- Sacroiliac Injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Jun 2013 (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.
The purpose of this study is to determine the predictive value of a composite of 3 simple clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection.
Detailed description
The purpose of this study is to determine the predictive value of a composite of 3 simple, clinically practical, diagnostic tests (Mekhail, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection. The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of SIJ mediated pain. . Specifically, we seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately predict the response (change in VAS) of a single diagnostic Sacroiliac joint and extra-capsular joint injection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diagnostic exercises | Experimental | Other: diagnostic exercisesThe three diagnostic exercises will be administered in random order to minimize effects of order and period on the results. Enrollment logs and study randomization will be administered electronically via a respective REDCap data modules. The enrollment, randomization and diagnostic tests will be administered by research coordinator or PI. The patients will be independently evaluated and scheduled for SIJ injection by Cleveland Clinic pain clinic staff and fellow pain physicians. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient presenting with low back pain with or without radicular symptoms, regardless of prior history of back surgery from 18-90 years old whom after being evaluated by an independent clinician in the Cleveland Clinic pain clinic has been scheduled for a diagnostic SIJ injection.
Key exclusion criteria (1 listed)
- any patient less than 18 or greater than 90 years old, has any medical condition that would not allow them to complete the study, diagnosis of any recent fractures in the lumbar spine, recent infection, pregnancy, taking anticoagulants.
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 |
|---|---|---|
| diagnostic exercisesAlso: questionnaires, pain surveys | Other | diagnostic exercises |
Primary outcome
validity of assessments
Time frame: Day 1
The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of Sacroiliac joint (SIJ) mediated pain.
1 secondary outcome
prognostic assessment
Time frame: Day 1
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 13 Apr 2017.
- 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.
Maged Guirguis, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diagnostic exercises in people with Sacroiliac Injection, run by The Cleveland Clinic 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 1 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 13 Apr 2017. 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?
validity of assessments (time frame: Day 1). 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 13 Apr 2017.