Sacroiliac Joint PainNCT02096653
Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
A study testing X-ray SI joint steroid injection and Landmark-guided SI steroid injection in people with Sacroiliac Joint Pain, run by Johns Hopkins University at 4 sites in United States.
Trial summary
In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sacroiliac Joint Pain
- What is being tested?
- X-ray SI joint steroid injection and Landmark-guided SI steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 4 sitesUnited States
- Study dates
- May 2014to Nov 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18;
- Low back pain principally below the L5 vertebra;
- Three out of 6 positive SI joint provocative maneuvers;
- Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
- Average pain score > 3/10 over the past week;
- Pain duration > 6 weeks;
Who cannot join
- Previous SI joint injection;
- Leg pain > back pain or lower leg pain > upper leg pain
- Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
- Untreated coagulopathy;
- Allergy to contrast dye or bupivacaine;
- Pain > 20 years in duration;
- Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Penn State
Hershey, Pennsylvania, 17033
Walter Reed National Military Medical Center
Rockville, Maryland, 20889
Naval Hospital-San Diego
San Diego, California
About this study
Official title: Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.
Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.
- Conditions
- Sacroiliac Joint Pain
- Being tested
- X-ray SI joint steroid injection, Landmark-guided SI steroid injection
- Keywords
- sacroiliac joint, low back pain, steroid injection
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-ray SI joint steroid injectionProcedure or surgery
Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
Landmark-guided SI steroid injectionProcedure or surgery
Injection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)
| Study group | Role | What they receive |
|---|---|---|
| X-ray guided intra-articular injection | Experimental | Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance Receives: Procedure: X-ray SI joint steroid injection |
| Landmark-guided SI joint injection | Active comparator | Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml) Receives: Procedure: Landmark-guided SI steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
Measured: 1 month from the start of treatment
Secondary outcomes (10)
Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.
Measured: 1 month after the start of treatment
Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
Measured: 1 month from the start of treatment
Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
This outcome measure compares the average back pain at baseline to the average back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
Measured: 3 months from the start of treatment
Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
Measured: 3 months after the start of treatment
Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index
Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible.
Measured: 3 months after the start of treatment
Patient satisfaction of the procedure at 1 month measured using the Likert Scale
Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied.
Measured: 1 month
Patient satisfaction of the procedure at 3 months measured using the Likert Scale
Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied.
Measured: 3 months
Positive categorical outcome
Decrease in average back pain score at 1 month of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale
Measured: 1 month
Positive categorical outcome
Decrease in average back pain score at 3 months of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale
Measured: 3 months
Positive diagnostic blocks
The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sacroiliac Joint PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Participant, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Milton S. Hershey Medical Center, United States Naval Medical Center, San Diego
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02096653
- Sponsor's protocol ID
- NA_00092414
- Status last verified
- Feb 2018
- First submitted
- 22 Mar 2014
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
PubMed 23253394Cohen SP, Bicket MC, Kurihara C, Griffith SR, Fowler IM, Jacobs MB, Liu R, Anderson White M, Verdun AJ, Hari SB, Fisher RL, Pasquina PF, Vorobeychik Y. Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study. Mayo Clin Proc. 2019 Apr;94(4):628-642. doi: 10.1016/j.mayocp.2018.08.038. Epub 2019 Mar 8.
PubMed 30853260
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
- ClinicalTrials.gov ID
- NCT02096653
- Acronym / sponsor ID
- NA_00092414
- Conditions
- Sacroiliac Joint Pain
- Keywords
- sacroiliac joint, low back pain, steroid injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, Walter Reed National Military Medical Center, Milton S. Hershey Medical Center, United States Naval Medical Center, San Diego
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 26 Mar 2014 (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.
In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.
Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| X-ray guided intra-articular injection | Experimental | Procedure: X-ray SI joint steroid injectionInjection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance |
| Landmark-guided SI joint injection | Active comparator | Procedure: Landmark-guided SI steroid injectionInjection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18;
- Low back pain principally below the L5 vertebra;
- Three out of 6 positive SI joint provocative maneuvers;
- Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
- Average pain score > 3/10 over the past week;
Key exclusion criteria (7 listed)
- Previous SI joint injection;
- Leg pain > back pain or lower leg pain > upper leg pain
- Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
- Untreated coagulopathy;
- Allergy to contrast dye or bupivacaine;
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 |
|---|---|---|
| X-ray SI joint steroid injectionInjection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance | Procedure or surgery | X-ray guided intra-articular injection |
| Landmark-guided SI steroid injectionInjection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular) | Procedure or surgery | Landmark-guided SI joint injection |
Primary outcome
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
Time frame: 1 month from the start of treatment
This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
10 secondary outcomes
Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
Time frame: 1 month after the start of treatment
Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
Time frame: 1 month from the start of treatment
Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
Time frame: 3 months from the start of treatment
Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
Time frame: 3 months after the start of treatment
Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index
Time frame: 3 months after the start of treatment
Patient satisfaction of the procedure at 1 month measured using the Likert Scale
Time frame: 1 month
Patient satisfaction of the procedure at 3 months measured using the Likert Scale
Time frame: 3 months
Positive categorical outcome
Time frame: 1 month
Positive categorical outcome
Time frame: 3 months
Positive diagnostic blocks
Time frame: 6 hours
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 7 Feb 2018.
- Background: PubMed 23253394Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148.
- Derived from this study: PubMed 30853260Cohen SP, Bicket MC, Kurihara C, Griffith SR, Fowler IM, Jacobs MB, Liu R, Anderson White M, Verdun AJ, Hari SB, Fisher RL, Pasquina PF, Vorobeychik Y. Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study. Mayo Clin Proc. 2019 Apr;94(4):628-642. doi: 10.1016/j.mayocp.2018.08.038. Epub 2019 Mar 8.
- Individual participant dataSharing planned: No
Related trials for Sacroiliac Joint Pain
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruitingObservational study
Does Injection Target Matter in Sacroiliac Joint Dysfunction?
Sacroiliac Joint Dysfunction, Multifidus
RecruitingEarly Phase 1
Ketorolac Versus Corticosteroid Injections for Sacroiliac Joint Pain
Sacro-iliac Joint Pain
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
Postural Correction and Lumbar Stabilization vs MET for Postpartum Pain
Postpartum
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X-ray SI joint steroid injection and Landmark-guided SI steroid injection in people with Sacroiliac Joint Pain, run by Johns Hopkins University at 4 sites 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 7 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 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale (time frame: 1 month from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02096653, which also lists 2 linked publications.
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 7 Feb 2018.