Sacroiliac Joint Pain Clinical Trial
Official title:
Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
Verified date | February 2018 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 125 |
Est. completion date | November 2017 |
Est. primary completion date | November 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. Age > 18; 2. Low back pain principally below the L5 vertebra; 3. Three out of 6 positive SI joint provocative maneuvers; 4. Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes; 5. Average pain score > 3/10 over the past week; 6. Pain duration > 6 weeks; Exclusion Criteria: 1. Previous SI joint injection; 2. Leg pain > back pain or lower leg pain > upper leg pain 3. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis); 4. Untreated coagulopathy; 5. Allergy to contrast dye or bupivacaine; 6. Pain > 20 years in duration; 7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Hospital | Baltimore | Maryland |
United States | Penn State | Hershey | Pennsylvania |
United States | Walter Reed National Military Medical Center | Rockville | Maryland |
United States | Naval Hospital-San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | Milton S. Hershey Medical Center, Uniformed Services University of the Health Sciences, United States Naval Medical Center, San Diego, Walter Reed National Military Medical Center |
United States,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 month from the start of treatment | |
Secondary | 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. | 1 month after the start of treatment | |
Secondary | 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. | 1 month from the start of treatment | |
Secondary | 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. | 3 months from the start of treatment | |
Secondary | 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. | 3 months after the start of treatment | |
Secondary | 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. | 3 months after the start of treatment | |
Secondary | 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. | 1 month | |
Secondary | 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. | 3 months | |
Secondary | 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 | 1 month | |
Secondary | 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 | 3 months | |
Secondary | Positive diagnostic blocks | The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary | 6 hours |
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