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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
125
Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
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)
Naval Hospital-San Diego
San Diego, California, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Walter Reed National Military Medical Center
Rockville, Maryland, United States
Penn State
Hershey, Pennsylvania, United States
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.
Time frame: 1 month from the start of treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 3 months
Positive diagnostic blocks
The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary
Time frame: 6 hours
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