TY - JOUR
T1 - Cryotherapy for treatment of chronic rhinitis
T2 - 3-month outcomes of a randomized, sham-controlled trial
AU - Del Signore, Anthony G.
AU - Greene, Joshua B.
AU - Russell, Joseph L.
AU - Yen, David M.
AU - O'Malley, Ellen M.
AU - Schlosser, Rodney J.
N1 - Funding Information:
source for the study: Stryker ENTThe authors thank Lisa Thackeray, MS, of North American Statistical Associates, Minneapolis, MN, for statistical analysis. In addition to the authors, the following investigators and study coordinators contributed to the data collection for this study: Satish Govindaraj, MD, Alfred Iloreta, MD, Rosalie Machado, Naa-Akomaah Yeboah, Annie Arrighi-Allisan, and Katherine Garvey of Mount Sinai, New York, NY; Dee Vester, RN, BSN, and Lisa Ruehr of Ascension St. Vincent Anderson, Anderson, IN; John Ramey, MD, Patricia Gerber, MD, Ned Rupp, MD, and April Bell of National Allergy and ENT, North Charleston, SC; Jeffrey Bedrosian, MD, David Brown, MD, Jarrod Keeler, MD, Thomas Koch, MD, and David Campbell of Specialty Physician Associates, Bethlehem, PA; Ryan Little, MD, Shaun Nguyen, MD, Zachary Soler, MD, Tiffany Garris Wall, DNP, Thomas Lackland, and Kathy Zhang of the Medical University of South Carolina, Charleston, SC; Curtis Johnson, DO, Jon Rosenthal, DO, Heather Cousino, PA, Christina Gutierrez, PA, and Lindsay Dwyer of Ear, Nose, and Throat Associates of South Florida, PA, Coral Springs, FL; Alan Pokorny, MD, Michael Cruz, MD, David Stoddard, MD, Karee Ledeboer, ARNP, and Christi Witte, CMA, CCRC, of Spokane ENT, Spokane, WA; Theodore Truitt, MD, Stephen Cragle, MD, Alisse Amundson, RN, and Jen Wipper of St. Cloud ENT, St. Cloud, MN; Steven Davis, MD, Amrita Desai, PA, Erin Shisido, PA, and Gladys Sager of Breathe Clear Institute, Torrance, CA; Gavin Setzen, MD, Nora Perkins, MD, and Julie Baum of Albany ENT and Allergy Services, PC, Albany, NY; Robert Standring, MD, Bernadette Calado, and Sarina Zmijewski of Ear Nose Throat Consultants, Southfield, MI; Bryan Davis, MD, Robert Keller, MD, Barton Knox, MD, Matthew Whinery, MD, Monica Davis, and Sierra Archuleta of Colorado ENT and Allergy, Colorado Springs, CO.
Publisher Copyright:
© 2021 The Authors. International Forum of Allergy & Rhinology published by Wiley Periodicals LLC on behalf of American Academy of Otolaryngic Allergy and American Rhinologic Society
PY - 2022/1
Y1 - 2022/1
N2 - Background: The purpose of this study was to test whether cryotherapy is superior to a sham procedure for reducing symptoms of chronic rhinitis. Methods: This study was a prospective, multicenter, 1:1 randomized, sham-controlled, patient-blinded trial. The predetermined sample size was 61 participants per arm. Adults with moderate/severe symptoms of chronic rhinitis who were candidates for cryotherapy under local anesthesia were enrolled. Participants were required to have minimum reflective Total Nasal Symptom Scores (rTNSSs) of 4 for total, 2 for rhinorrhea, and 1 for nasal congestion. Follow-up visits occurred at 30 and 90 days postprocedure. Patient-reported outcome measures included the rTNSS, standardized Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)], and Nasal Obstruction Symptom Evaluation (NOSE) questionnaires. Adverse events were also recorded. The primary endpoint was the comparison between the treatment and sham arms for the percentage of responders at 90 days. Responders were defined as participants with a 30% or greater reduction in rTNSS relative to baseline. Results: Twelve US investigational centers enrolled 133 participants. The primary endpoint analysis included 127 participants (64 active, 63 sham) with 90-day results. The treatment arm was superior at the 90-day follow-up with 73.4% (47 of 64) responders compared with 36.5% (23 of 63) in the sham arm (p < 0.001). There were greater improvements in the rTNSS, RQLQ(S), and NOSE scores for the active arm over the sham arm at the 90-day follow-up (p < 0.001). One serious procedure-related adverse event of anxiety/panic attack was reported. Conclusion: Cryotherapy is superior to a sham procedure for improving chronic rhinitis symptoms and patient quality of life.
AB - Background: The purpose of this study was to test whether cryotherapy is superior to a sham procedure for reducing symptoms of chronic rhinitis. Methods: This study was a prospective, multicenter, 1:1 randomized, sham-controlled, patient-blinded trial. The predetermined sample size was 61 participants per arm. Adults with moderate/severe symptoms of chronic rhinitis who were candidates for cryotherapy under local anesthesia were enrolled. Participants were required to have minimum reflective Total Nasal Symptom Scores (rTNSSs) of 4 for total, 2 for rhinorrhea, and 1 for nasal congestion. Follow-up visits occurred at 30 and 90 days postprocedure. Patient-reported outcome measures included the rTNSS, standardized Rhinoconjunctivitis Quality of Life Questionnaire [RQLQ(S)], and Nasal Obstruction Symptom Evaluation (NOSE) questionnaires. Adverse events were also recorded. The primary endpoint was the comparison between the treatment and sham arms for the percentage of responders at 90 days. Responders were defined as participants with a 30% or greater reduction in rTNSS relative to baseline. Results: Twelve US investigational centers enrolled 133 participants. The primary endpoint analysis included 127 participants (64 active, 63 sham) with 90-day results. The treatment arm was superior at the 90-day follow-up with 73.4% (47 of 64) responders compared with 36.5% (23 of 63) in the sham arm (p < 0.001). There were greater improvements in the rTNSS, RQLQ(S), and NOSE scores for the active arm over the sham arm at the 90-day follow-up (p < 0.001). One serious procedure-related adverse event of anxiety/panic attack was reported. Conclusion: Cryotherapy is superior to a sham procedure for improving chronic rhinitis symptoms and patient quality of life.
UR - http://www.scopus.com/inward/record.url?scp=85111873919&partnerID=8YFLogxK
U2 - 10.1002/alr.22868
DO - 10.1002/alr.22868
M3 - Article
C2 - 34355872
AN - SCOPUS:85111873919
SN - 2042-6976
VL - 12
SP - 51
EP - 61
JO - International Forum of Allergy and Rhinology
JF - International Forum of Allergy and Rhinology
IS - 1
ER -