T L Smith1, A J Correa, T Kuo, L Reinisch. 1. Department of Otolaryngology and Communication Sciences, Medical College of Wisconsin, Milwaukee 53226-3522, USA.
Abstract
OBJECTIVE: The objective of this clinical trial was to assess the safety and efficacy of radiofrequency (RF) tissue ablation of the inferior turbinates in the treatment of nasal obstruction using an RF energy delivery system with a thermocouple feedback electrode. METHODS: A prospective, nonrandomized study of 11 patients (mean age, 47+/-12 y) with chronic nasal obstruction was conducted. Using patient-based visual analogue scales (VAS), symptom parameters were assessed. These included degree of nasal obstruction, frequency of nasal obstruction, and pain. Physician assessment of nasal obstruction was also collected by the principal investigator. Follow-up was conducted at 24 hours, 1 week, 4 weeks, 8 weeks, and 1 year. ANOVA was carried out to determine statistically significant differences in the data. Data were fit to a regression model, and confidence intervals were determined from a 95% confidence level. RESULTS: In patient-assessed degree of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.001, P<.0001, and P<.0008, respectively). There was no difference between 8 weeks and 1 year (P<.15). The data appeared to follow an exponential decay to a constant value. The pretreatment baseline average degree of obstruction was 7.5+/-0.5 on a scale of 0 to 10. The degree of obstruction after 8 weeks was 2.7+/-0.6. The time constant for this change was 21 days to reach 90% of the final value. At 1 year, degree of obstruction was 3.3+/-0.7. For frequency of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.0001, P<.0001, and P<.0001, respectively). There was no difference between 8 weeks and 1 year (P<.15). The pretreatment baseline average frequency of obstruction was 7.8+/-0.5. The remaining frequency of obstruction after 8 weeks was 2.9+/-0.6. The time constant was 18 days. At 1 year, frequency of obstruction was 3.3+/-0.6. Physician assessment of nasal obstruction revealed statistical significance among baseline and 4 weeks, and baseline and 8 weeks (P<.0055 and P<.0056, respectively). There was no difference between 4 weeks and 8 weeks (P<.24). The average initial obstruction was 83%+/-4%. The remaining obstruction after 8 weeks was 58% +/-5%. The time constant was 14 days. Mild pain was reported by 55% of patients during the procedure; the remaining 45% reported no pain. Only one patient required pain medication consisting of acetaminophen after the procedure. There were no significant complications. CONCLUSIONS: Degree and frequency of nasal obstruction, as reported by patients, decreased following RF tissue ablation of the inferior turbinates. This improvement in symptoms was still evident after 1 year (P<.001). Physician assessment of obstruction also correlated with patient reports for the initial 8-week study period. The procedure was safe and well tolerated. Thermocouples within the active electrode provided additional feedback to the operating surgeon allowing the use of relatively lower tissue temperatures, power, and energy as compared with traditional techniques. These results support the need for continued research to evaluate this modality as a treatment for chronic nasal obstruction.
OBJECTIVE: The objective of this clinical trial was to assess the safety and efficacy of radiofrequency (RF) tissue ablation of the inferior turbinates in the treatment of nasal obstruction using an RF energy delivery system with a thermocouple feedback electrode. METHODS: A prospective, nonrandomized study of 11 patients (mean age, 47+/-12 y) with chronic nasal obstruction was conducted. Using patient-based visual analogue scales (VAS), symptom parameters were assessed. These included degree of nasal obstruction, frequency of nasal obstruction, and pain. Physician assessment of nasal obstruction was also collected by the principal investigator. Follow-up was conducted at 24 hours, 1 week, 4 weeks, 8 weeks, and 1 year. ANOVA was carried out to determine statistically significant differences in the data. Data were fit to a regression model, and confidence intervals were determined from a 95% confidence level. RESULTS: In patient-assessed degree of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.001, P<.0001, and P<.0008, respectively). There was no difference between 8 weeks and 1 year (P<.15). The data appeared to follow an exponential decay to a constant value. The pretreatment baseline average degree of obstruction was 7.5+/-0.5 on a scale of 0 to 10. The degree of obstruction after 8 weeks was 2.7+/-0.6. The time constant for this change was 21 days to reach 90% of the final value. At 1 year, degree of obstruction was 3.3+/-0.7. For frequency of nasal obstruction, statistical significance was seen among baseline and 4 weeks, 8 weeks, and 1 year (P<.0001, P<.0001, and P<.0001, respectively). There was no difference between 8 weeks and 1 year (P<.15). The pretreatment baseline average frequency of obstruction was 7.8+/-0.5. The remaining frequency of obstruction after 8 weeks was 2.9+/-0.6. The time constant was 18 days. At 1 year, frequency of obstruction was 3.3+/-0.6. Physician assessment of nasal obstruction revealed statistical significance among baseline and 4 weeks, and baseline and 8 weeks (P<.0055 and P<.0056, respectively). There was no difference between 4 weeks and 8 weeks (P<.24). The average initial obstruction was 83%+/-4%. The remaining obstruction after 8 weeks was 58% +/-5%. The time constant was 14 days. Mild pain was reported by 55% of patients during the procedure; the remaining 45% reported no pain. Only one patient required pain medication consisting of acetaminophen after the procedure. There were no significant complications. CONCLUSIONS: Degree and frequency of nasal obstruction, as reported by patients, decreased following RF tissue ablation of the inferior turbinates. This improvement in symptoms was still evident after 1 year (P<.001). Physician assessment of obstruction also correlated with patient reports for the initial 8-week study period. The procedure was safe and well tolerated. Thermocouples within the active electrode provided additional feedback to the operating surgeon allowing the use of relatively lower tissue temperatures, power, and energy as compared with traditional techniques. These results support the need for continued research to evaluate this modality as a treatment for chronic nasal obstruction.
Authors: Gregor M Bran; Sophia Hünnebeck; Raphael M Herr; Karl Hörmann; Boris A Stuck Journal: Eur Arch Otorhinolaryngol Date: 2012-06-28 Impact factor: 2.503