Cooled radiofrequency ablation (CRFA) outperforms standard medical management for chronic sacroiliac joint pain, according to study results published in Regional Anesthesia and Pain Medicine.
While sacral lateral branch CRFA has been proven efficacious for chronic sacroiliac joint pain, research lacked comparative analysis with standard of care. To compare the outcomes of CRFA with standard treatment of chronic sacroiliac joint pain, researchers conducted a randomized, multicenter comparative effectiveness study (ClinicalTrials.gov Identifier: NCT03601949).
The study enrolled 210 patients with pain suspected to originate from the sacroiliac joint and who benefitted from diagnostic sacroiliac joint injections and prognostic lateral branch blocks. These patients were randomly assigned to receive CRFA of the L5 dorsal ramus and S1 to S3 lateral branches or standard treatment with drugs (injections into the sacroiliac ligaments or joint cavity, and integrative therapy including physical and chiropractic therapy, lifestyle changes, acupuncture, and yoga). However, patients were not allowed to receive acupuncture or injections within 4 weeks of their follow-up visits.
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The primary outcome measure of the study was mean reduction in low back pain score assessed on a Numeric Rating Scale (NRS) of 0 to 10 after 3 months. Secondary outcomes were function measured with the Oswestry Disability Index score and quality of life assessed with the EuroQoL-5 score.
Three months after treatment, the mean [SD] NRS pain score for the group who received CRFA was 3.8[2.4] (mean reduction, 2.5[2.5]) vs 5.9[1.7] (mean reduction, 0.4[1.7]) for the group who received standard treatment (P <.0001). More than half (52.3%) of the group who received CRFA reported a reduction of at least 2 points in NRS score, or 30% pain relief, compared with 4.3% of those who received standard treatment (P <.0001).
The group who received CRFA also experienced greater improvements in the Oswestry Disability Index score and EuroQoL-5 score. Oswestry Disability Index scores were 29.7[15.2] in the CRFA group vs 41.5[13.6] in the standard treatment group (P <.0001). Mean EuroQoL-5 scores were 0.68[0.22] in the CRFA group vs 0.47[0.29] in the standard treatment group (P <.0001).
“The majority of subjects receiving CRFA reported meaningful improvements in pain, function and quality of life, despite reporting a long duration of pain,” the study authors noted. “CRFA may be particularly well suited to treat SIJ pain, as the results of this and other randomized trials demonstrate.”
Study limitations include an inability to blind participants to the type of treatment received. Second, some patients who received standard treatment may have already failed trials of the interventions received, which may have increased the expectations of the patients assigned to receive CRFA. The placebo effect may have been attenuated by the complexity of chronic low back pain and the chance that patients had secondary sources of pain. Finally, the absence of specific requirements for the control group who received standard treatment could affect the generalizability of the study’s results.
Disclosure: This research was supported by Avanos Medical, the manufacturer of the CFRA device. Some study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Cohen SP, Kapural L, Kohan L, et al. Cooled radiofrequency ablation versus standard medical management for chronic sacroiliac joint pain: a multicenter, randomized comparative effectiveness study. Reg Anesth Pain Med. Published online July 5, 2023. doi:10.1136/rapm-2023-104568
This article originally appeared on Clinical Pain Advisor
