Randomized Sham-controlled Double-Blind Multicenter Clinical Trial to Ascertain the Effect of Percutaneous Radiofrequency Treatment for Sacroiliac Joint Pain: Three-month Results. Issue 11 (November 2016)

• Record Type: Journal Article
• Authors: van Tilburg, Cornelis W.J.; Schuurmans, Fleur A.; Stronks, Dirk L.; Groeneweg, Johannes G.; Huygen, Frank J.P.M.
• Is Part Of: Clinical journal of pain. Volume 32:Issue 11(2016)
• Publication Date: 2016-11
• Subjects: sacroiliac joint -- radiofrequency -- RCT -- sham -- chronic pain; Pain -- Periodicals; Pain -- Treatment -- Periodicals; Analgesia -- Periodicals; 616.047205
• DOI: 10.1097/AJP.0000000000000351
• Languages: English
• ISSNs: 0749-8047

Abstract

Abstract : Objectives: To investigate the effect of a percutaneous radiofrequency (RF) heat lesion compared with a sham procedure, applied to the lateral branches of L5, S1, S2, S3, and S4 nerve roots. Materials and Methods: Sixty patients aged 18 years and above with a medical history and physical examination suggestive for sacroiliac joint pain and a reduction of 2 or more on a numerical rating scale (NRS, 0 to 10) after a sacroiliac joint test block were included in this study. Treatment group: percutaneous RF heat lesion at the lateral branches of S1, S2, S3, and S4 nerve roots and the posterior ramus dorsalis of L5; sham group: same procedure as the treatment group except for the RF heat lesion. Primary outcome measure: pain reduction (NRS). Secondary outcome measure: Global Perceived Effect. Results: No statistically significant differences in pain level over time between the groups (Group×Period) ( F 1, 58 =0.353; P =0.56) nor within the treatment Group ( F 1, 58 =0.212; P =0.65) were found. The Period factor, however, yielded a significant difference ( F 1, 58 =61.67; P <0.001), that is, when pooled together the mean pain level of the patients was significantly reduced at T1 compared with T0. In the crossover group, 42.1% experienced a reduction in NRS of 2 or more at 1 month ( P =0.65). No statistically significant difference in satisfaction over time between the groups was found ( F 1, 50 =2.1; P =0.15). The independent factors Group ( F 1, 50 =2.02; P =0.16) and Period ( F 1, 50 =0.95; P =0.33) also showed no statistically significant difference. The same applies to recovery: no statistically significant Group×Period effect ( F 1, 51 =0.09; P =0.77) was found, neither an effect of Group ( F 1, 51 =0.004; P =0.95) nor of Period ( F 1, 51 =0.27; P =0.60). Discussion: The hypothesis of no difference in pain reduction or in Global Perceived Effect between the treatment and sham group cannot be rejected. Level of Evidence: Level 1A.