Twelve-Month Follow-Up of a Randomized Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Region XXXX .

@entity1 @entity615 @entity5036 @entity158 @entity717
OBJECTIVE: The objective of this study was to report the long-term outcomes of cooled radiofrequency (CRF) @entity5036 ( @entity5036 ) as a treatment for sacroiliac (SI) region @entity158 . Whereas the 1-, 3-, 6-, and 9-month outcomes of this procedure compared to sham treatment were previously reported, this current report shows the 12-month outcomes of CRF/ @entity5036 treatment for SI region @entity158 . DESIGN: This study originally included 51 subjects who were randomized 2:1 to receive CRF/ @entity5036 treatment or a sham intervention, respectively, for SI region @entity158 . Subjects and assessors were blinded for 3  months. At that time, sham @entity1 were permitted to receive CRF/ @entity5036 , designated as "crossover" study subjects, and followed for 6 additional months. For the purpose of this evaluation, the original CRF/ @entity5036 -treated study subjects were followed for a total of 12  months. Study @entity1 were 18 to 88  years of age and had chronic (symptomatic for >6  months) @entity615 . All subjects were qualified for study inclusion following positive responses to dual lateral branch blocks. @entity5036 was performed by CRF to ablate the S1 to S3 lateral branches and the L5 dorsal ramus. @entity158 was measured by a numerical rating scale (NRS) and Short Form 36-bodily @entity158 (SF36-BP) scores. The @entity717 index and Short Form 36-physical functioning (SF36-PF) assessment each served to evaluate subject disability. Treatment successes ("responders") in the originally treated CRF/ @entity5036 group at 12  months, and in the crossover group at 6  months, were also determined. RESULTS: In the original CRF/ @entity5036 treatment group, 12-month outcomes compared to baseline were favorable, with a mean 2.7 point drop in the NRS score, a 13.9 decrease in the ODI, and a 15.8 increase in SF-36BP. In the crossover study group, 6-month outcomes were also favorable, with a mean NRS score decrease of 2.5 points, a reduction in ODI of 8.8, and an increase in SF36-BP of 11.9. CONCLUSIONS: These favorable 12-month results illustrate the durability of effective CRF/ @entity5036 -mediated treatment of SI region @entity158 for selected @entity1 . Furthermore, successful CRF/ @entity5036 treatments in unblinded crossover study subjects demonstrate the unlikelihood that such positive outcomes are attributable to a "placebo" effect, and suggest that CRF/ @entity5036 is an effective therapeutic option for alleviating @entity158 , and improving physical function and quality of life, with few complications.
