Pain Medicine Center, Department of Anesthesiology, Naval Medical Center, San Diego
San Diego, California, 92134, United States
NCT Number: NCT02420041
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92134, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
Time frame: 2 weeks post-procedure
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.
Time frame: 3 months post-procedure
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.
Time frame: during/just before sacroiliac (SI) injection and 2 weeks post-procedure
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.
Time frame: during/just before sacroiliac (SI) injection and 3 months post-procedure
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.
Time frame: 2 weeks post-procedure
"1= very dissatisfied" to "5=very satisfied".
Time frame: 3 months post-procedure
"1= very dissatisfied" to "5=very satisfied".
United States Naval Medical Center, San Diego
Fed
Comparison of the Efficacy of Two Techniques for Sacroiliac Joint Injection: Ultrasound Guidance Versus Fluoroscopic Guidance
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05203926
Arthritis, Joint Diseases
New York, United States
View Trial DetailsNCT03122119
Arthritis, Back Pain
Golden, Colorado, United States
View Trial DetailsNCT04314609
Arthritis, Joint Diseases
Cairo, Egypt
View Trial DetailsNCT02098694
Ankylosis, Arthritis
Ålesund, Norway
View Trial Details