SacroiliitisNCT02420041
Comparing the Effects of Ultrasound Versus Fluoroscopy for Sacroiliac Joint Injections
A study testing Active comparator: Fluoroscopic Guided SIJ injection, Ultrasound Guided Sacroiliac Joint Injection and Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle in people with Sacroiliitis, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
The purpose of this research project is to compare two different techniques for performing an injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal of the study is to determine if one technique is better than the other with respect to improvement in a patient's pain, function, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliitis
- What is being tested?
- Active comparator: Fluoroscopic Guided SIJ injection, Ultrasound Guided Sacroiliac Joint Injection and Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2014
- 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
- Diagnosis of SIJ dysfunction by history and physical exam
- History: Either low back pain or buttock pain
- Exam: Either tenderness to palpation over the SIJ or a positive provocative maneuver (i.e., Patrick's, Gaenslen's, and/or Yeoman's test)
- Failed a trial of conservative therapy which may included medications, physical therapy, or both
- Age > 18
- Patient agrees to participate in study
Who cannot join
- Coagulopathy
- Renal or Hepatic Failure
- Current Pregnancy or actively pursuing pregnancy
- Known allergy to local anesthetic or steroids
- Infection at site of needle placement or SIJ infection
- Patient unable to consent himself or herself
Show all 9Show fewer
- Patient refusal
- Prior surgical procedures involving the SIJ
- Body Mass Index > 35 kg/m2
Trial locations and contacts
1 site in 1 country.
United States1 site
Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego
San Diego, California, 92134
About this study
Official title: Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance
The purpose of this research project is to compare two different techniques for performing an injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal of the study is to determine if one technique is better than the other with respect to improvement in a patient's pain, function, and his or her satisfaction. Additionally, the investigators want to determine if one technique is quicker and more efficient than the other.
Read the detailed description
Sacroiliac joint dysfunction is a source of low back pain that causes significant pain and disability. Injection of the sacroiliac joint with a local anesthetic/corticosteroid mixture has shown efficacy in treating this condition, when conservative therapy fails. The use of fluoroscopic guidance and anatomic landmarks are traditional methods for performing this injection; however, ultrasound imaging has recently been utilized for performing this procedure. Although studies exist that describe and validate the ultrasound technique, no studies exist that compare the techniques with respect to short-term and long-term outcomes. In this study, the primary objective is to determine if a difference exists between a fluoroscopic-guided technique and ultrasound-guided technique with respect to pain and function. A secondary objective is to compare the two techniques with respect to procedural characteristics.
- Conditions
- Sacroiliitis
- Being tested
- Active comparator: Fluoroscopic Guided SIJ injection, Ultrasound Guided Sacroiliac Joint Injection, Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle, SonoSite S-nerve, iohexol
- Keywords
- Sacroiliac Joint Injection, Fluoroscopy, Ultrasound
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active comparator: Fluoroscopic Guided SIJ injectionProcedure or surgery
- Needle entry point is in the lower one-third of the SIJ
- Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry
- Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a coaxial fashion into the SIJ
- 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake
- Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine
- Patient observed in recovery bay for 20 minutes and then discharged home
Ultrasound Guided Sacroiliac Joint InjectionProcedure or surgery
- Sterile preparation (with chlorhexidine) and drape
- Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer
- 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry
- Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not "spill out" onto sacrum).
- After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected.
- Patient observed in recovery bay for 20 minutes and then discharged home
Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needleDevice
SonoSite S-nerveDevice
iohexolDevice
triamcinolone/lidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopic Guidance | Active comparator | Patients referred to the Naval Medical Center-San Diego Pain Medicine Clinic. Need a history and physical showing objective findings of sacroiliac joint (SIJ) dysfunction. If the patient meets inclusion / exclusion criteria, they will be presented with the study. After accepting and being consented, they will then be scheduled. The day of the appointment they will be randomised to Group A or B. In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint. Then complete the multidimensional pain inventory (MPI) and rate their pain on the NRS from 0-11. After procedure, they will rate their pain from 0-10 in the recovery area and then be discharged to home. They will complete an MPI, Patient Global Impression of Change (PGIC), numerical rating scale (NRS), and adverse events questionnaire 1-2 weeks post-procedure and 3 months post-procedure. Receives: Procedure: Active comparator: Fluoroscopic Guided SIJ injection; Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle; Device: iohexol; Drug: triamcinolone/lidocaine |
| Ultrasound Guidance | Experimental | Patients referred to the Naval Medical Center-San Diego Pain Medicine Clinic. Need a history and physical showing objective findings of SIJ dysfunction. If the patient meets inclusion / exclusion criteria, they will be presented with the study. After accepting and being consented, they will then be scheduled. The day of the appointment they will be randomised to Group A or B. In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint. Then complete the MPI and rate their pain on the NRS from 0-11. After procedure, they will rate their pain from 0-10 in the recovery area and then be discharged to home. They will complete an MPI, Patient Global Impression of Change (PIGC), NRS, and adverse events questionnaire 1-2 weeks post-procedure and 3 months post-procedure. Receives: Procedure: Ultrasound Guided Sacroiliac Joint Injection; Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle; Device: SonoSite S-nerve; Drug: triamcinolone/lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy
during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
Measured: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes
Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Measured: 30 minutes pre-procedure minus baseline
Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Measured: 2 weeks post-procedure minus baseline
Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Measured: 3 months post-procedure minus baseline
Secondary outcomes (6)
Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale
Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.
Measured: 2 weeks post-procedure
Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale
Study subjects rate their change in overall condition on a scale of 0-6 (0=no change, 6=better and a definite improvement that has made a real worthwhile difference). The range of the change in pain for both groups observed was in fact 0-5.
Measured: 3 months post-procedure
Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome. Score reported is reporting a difference/change between two time points.
Measured: during/just before sacroiliac (SI) injection and 2 weeks post-procedure
Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.Score reported is reporting a difference/change between two time points.
Measured: during/just before sacroiliac (SI) injection and 3 months post-procedure
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
"1= very dissatisfied" to "5=very satisfied".
Measured: 2 weeks post-procedure
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
"1= very dissatisfied" to "5=very satisfied".
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
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 SacroiliitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- United States Naval Medical Center, Portsmouth
- Responsible party
- Sponsor
- Investigators
- Steven R Hanling, MD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420041
- Sponsor's protocol ID
- NMCSD.2012.0112
- Status last verified
- Oct 2015
- First submitted
- 30 Sep 2014
- Last updated
- 13 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance
- ClinicalTrials.gov ID
- NCT02420041
- Acronym / sponsor ID
- NMCSD.2012.0112
- Conditions
- Sacroiliitis
- Keywords
- Sacroiliac Joint Injection, Fluoroscopy, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- United States Naval Medical Center, Portsmouth
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Posted 13 Nov 2015
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 research project is to compare two different techniques for performing an injection of the sacroiliac joint. Although both techniques are safe and accurate, the goal of the study is to determine if one technique is better than the other with respect to improvement in a patient's pain, function, and his or her satisfaction. Additionally, the investigators want to determine if one technique is quicker and more efficient than the other.
Detailed description
Sacroiliac joint dysfunction is a source of low back pain that causes significant pain and disability. Injection of the sacroiliac joint with a local anesthetic/corticosteroid mixture has shown efficacy in treating this condition, when conservative therapy fails. The use of fluoroscopic guidance and anatomic landmarks are traditional methods for performing this injection; however, ultrasound imaging has recently been utilized for performing this procedure. Although studies exist that describe and validate the ultrasound technique, no studies exist that compare the techniques with respect to short-term and long-term outcomes. In this study, the primary objective is to determine if a difference exists between a fluoroscopic-guided technique and ultrasound-guided technique with respect to pain and function. A secondary objective is to compare the two techniques with respect to procedural characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopic Guidance | Active comparator | Procedure: Active comparator: Fluoroscopic Guided SIJ injection, Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle, Device: iohexol, Drug: triamcinolone/lidocainePatients referred to the Naval Medical Center-San Diego Pain Medicine Clinic. Need a history and physical showing objective findings of sacroiliac joint (SIJ) dysfunction. If the patient meets inclusion / exclusion criteria, they will be presented with the study. After accepting and being consented, they will then be scheduled. The day of the appointment they will be randomised to Group A or B. In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint. Then complete the multidimensional pain inventory (MPI) and rate their pain on the NRS from 0-11. After procedure, they will rate their pain from 0-10 in the recovery area and then be discharged to home. They will complete an MPI, Patient Global Impression of Change (PGIC), numerical rating scale (NRS), and adverse events questionnaire 1-2 weeks post-procedure and 3 months post-procedure. |
| Ultrasound Guidance | Experimental | Procedure: Ultrasound Guided Sacroiliac Joint Injection, Device: Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle, Device: SonoSite S-nerve, Drug: triamcinolone/lidocainePatients referred to the Naval Medical Center-San Diego Pain Medicine Clinic. Need a history and physical showing objective findings of SIJ dysfunction. If the patient meets inclusion / exclusion criteria, they will be presented with the study. After accepting and being consented, they will then be scheduled. The day of the appointment they will be randomised to Group A or B. In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint. Then complete the MPI and rate their pain on the NRS from 0-11. After procedure, they will rate their pain from 0-10 in the recovery area and then be discharged to home. They will complete an MPI, Patient Global Impression of Change (PIGC), NRS, and adverse events questionnaire 1-2 weeks post-procedure and 3 months post-procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of SIJ dysfunction by history and physical exam
- Failed a trial of conservative therapy which may included medications, physical therapy, or both
- Age > 18
- Patient agrees to participate in study
Key exclusion criteria (9 listed)
- Coagulopathy
- Renal or Hepatic Failure
- Current Pregnancy or actively pursuing pregnancy
- Known allergy to local anesthetic or steroids
- Infection at site of needle placement or SIJ infection
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 |
|---|---|---|
| Active comparator: Fluoroscopic Guided SIJ injection* Needle entry point is in the lower one-third of the SIJ * Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry * Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a coaxial fashion into the SIJ * 1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake * Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine * Patient observed in recovery bay for 20 minutes and then discharged home | Procedure or surgery | Fluoroscopic Guidance |
| Ultrasound Guided Sacroiliac Joint Injection* Sterile preparation (with chlorhexidine) and drape * Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer * 3 mL of 1% lidocaine is injected subcutaneously at site of needle entry * Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not "spill out" onto sacrum). * After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected. * Patient observed in recovery bay for 20 minutes and then discharged home | Procedure or surgery | Ultrasound Guidance |
| Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle | Device | Fluoroscopic Guidance, Ultrasound Guidance |
| SonoSite S-nerve | Device | Ultrasound Guidance |
| iohexol | Device | Fluoroscopic Guidance |
| triamcinolone/lidocaine | Drug | Fluoroscopic Guidance, Ultrasound Guidance |
Primary outcome
Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy
Time frame: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes
during procedure from the time monitors are placed on patient to the time of withdrawal of needle from skin
Change in Pain Score From Baseline to 30 Minutes Pre-procedure Using the Defense and Veterans Pain Rating Scale (DoD/VA PRS) 0-10
Time frame: 30 minutes pre-procedure minus baseline
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Change in Pain Score From Baseline to 2 Weeks Post-procedure Using the DoD/VA PRS
Time frame: 2 weeks post-procedure minus baseline
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
Change in Pain Score From Baseline to 3 Months Post-procedure Using the DoD/VA PRS
Time frame: 3 months post-procedure minus baseline
Study subjects rate their pain on a scale of 0-10 (0=no pain, 10= the highest level of pain experienced), hence the lower the score the better the outcome.
6 secondary outcomes
Impression of Change of Condition at 2 Weeks Post-procedure Using the Patient Global Impression of Change (PGIC) Scale
Time frame: 2 weeks post-procedure
Impression of Change of Condition at 3 Months Post-procedure Using the PGIC Scale
Time frame: 3 months post-procedure
Change in Pain Score Since Sacroiliac (SI) Injection at 2 Weeks Post-procedure Using the DoD/VA PRS
Time frame: during/just before sacroiliac (SI) injection and 2 weeks post-procedure
Change in Pain Score Since SI Injection at 3 Months Post-procedure Using the DoD/VA PRS
Time frame: during/just before sacroiliac (SI) injection and 3 months post-procedure
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
Time frame: 2 weeks post-procedure
Satisfaction of Procedure as a Measure of Safety and Tolerability Using a Numerical Scale 1-5
Time frame: 3 months post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Sacroiliitis
RecruitingObservational study
Natural History and Development of Spondyloarthritis
Arthritis, Spondylitis, Ankylosing
Active, not recruitingObservational study
Post-Market Clinical Study on a Modular SI Joint Fusion System
Sacroiliitis, Sacroiliac Joint Dysfunction
Active, not recruitingPhase 4
A Study of Secukinumab to Evaluate Maintenance of Response in Participants With Non-radiographic Axial Spondyloarthritis Who Achieved Remission
Non-radiographic Axial Spondyloarthritis
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Degenerative Sacroiliitis, Sacroiliac Disorder
Not yet recruiting
Outcomes of Intra-articular Steroid Injection Via Ultrasound Guidance Versus Fluoroscopic Guidance in the Sacroiliac Joint in Patients With Sacroiliitis
Sacroiliitis
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.
Steven R Hanling, MD principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active comparator: Fluoroscopic Guided SIJ injection, Ultrasound Guided Sacroiliac Joint Injection and Havel's Inc. EchoStim (facet tip) 21 Gauge 4" needle in people with Sacroiliitis, run by United States Naval Medical Center, San Diego 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 6 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: finished, as of the sponsor's last update on 13 Nov 2015. 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 13 Nov 2015). 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?
Difference in Minutes Between a Sacroiliac Joint Injection Done With Ultrasound vs Fluoroscopy (time frame: difference in minutes between a sacroiliac joint injection, an expected average of 9 minutes). The study lists 4 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 13 Nov 2015.