P David Charles1, Aubrey Manack Adams2, Thomas Davis1, Kathryn Bradley1, Marc Schwartz3, Mitchell F Brin2,4, Atul T Patel5. 1. Vanderbilt University Medical Center, Nashville, Tennessee, U.S.A. 2. Allergan, Inc., Irvine, California, U.S.A. 3. MedNet Solutions, Inc., Minnetonka, Minnesota, U.S.A. 4. University of California, Irvine, California, U.S.A. 5. Kansas City Bone and Joint Clinic, Overland Park, Kansas, U.S.A.
Abstract
BACKGROUND: Pain is a prevailing feature of cervical dystonia (CD), the most common form of focal dystonia. This analysis examined pain relief after onabotulinumtoxinA treatment in CD subjects with moderate/severe pain from the Cervical Dystonia Patient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE). METHODS: CD PROBE was a prospective, multicenter, observational registry of CD subjects who were naïve to botulinum toxin (BoNT), new to physician, or had not received BoNT within ≥ 16 weeks if in a clinical trial. Subjects were eligible for 3 treatments, with variable session intervals. Descriptive and inferential statistics were utilized to evaluate the change in pain scores in the population with moderate/severe neck pain at baseline (Pain Numeric Rating Scale [PNRS] score 4 to 10). RESULTS: Of 1046 enrolled, 733 (70.7%) had moderate/severe neck pain at baseline. Postinjection pain questionnaire responses 4 to 6 weeks after each of the 3 treatments revealed that a majority of subjects (67.1%, 72.4%, and 76.4%) reported pain relief; mean time to pain relief was 7.1, 7.4, and 7.6 days. All pain scales showed significant improvements from baseline to final visit (all P < 0.0001): PNRS, mean 6.6 to 3.8; CD Impact Profile-58 Pain and Discomfort subscale, mean 78.7 to 56.5; and Toronto Western Spasmodic Torticollis Rating Scale Pain subscale, mean 12.6 to 8.5. Multivariable regression models showed that initial pain score significantly contributed to the final pain score for all scales. CONCLUSION: Results from this real-world clinical registry indicate that a majority of CD subjects with moderate/severe neck pain experience significant relief following onabotulinumtoxinA treatment.
BACKGROUND:Pain is a prevailing feature of cervical dystonia (CD), the most common form of focal dystonia. This analysis examined pain relief after onabotulinumtoxinA treatment in CD subjects with moderate/severe pain from the Cervical DystoniaPatient Registry for Observation of OnabotulinumtoxinA Efficacy (CD PROBE). METHODS: CD PROBE was a prospective, multicenter, observational registry of CD subjects who were naïve to botulinum toxin (BoNT), new to physician, or had not received BoNT within ≥ 16 weeks if in a clinical trial. Subjects were eligible for 3 treatments, with variable session intervals. Descriptive and inferential statistics were utilized to evaluate the change in pain scores in the population with moderate/severe neck pain at baseline (Pain Numeric Rating Scale [PNRS] score 4 to 10). RESULTS: Of 1046 enrolled, 733 (70.7%) had moderate/severe neck pain at baseline. Postinjection pain questionnaire responses 4 to 6 weeks after each of the 3 treatments revealed that a majority of subjects (67.1%, 72.4%, and 76.4%) reported pain relief; mean time to pain relief was 7.1, 7.4, and 7.6 days. All pain scales showed significant improvements from baseline to final visit (all P < 0.0001): PNRS, mean 6.6 to 3.8; CD Impact Profile-58 Pain and Discomfort subscale, mean 78.7 to 56.5; and Toronto Western Spasmodic Torticollis Rating Scale Pain subscale, mean 12.6 to 8.5. Multivariable regression models showed that initial pain score significantly contributed to the final pain score for all scales. CONCLUSION: Results from this real-world clinical registry indicate that a majority of CD subjects with moderate/severe neck pain experience significant relief following onabotulinumtoxinA treatment.
Authors: A R Bentivoglio; E Di Stasio; D Mulas; M L Cerbarano; T Ialongo; A Laurienzo; Martina Petracca Journal: Neurotox Res Date: 2017-05-06 Impact factor: 3.911
Authors: Pinky Agarwal; Richard Barbano; Henry Moore; Marc Schwartz; Aleksej Zuzek; Marjan Sadeghi; Atul Patel Journal: Front Neurol Date: 2022-06-30 Impact factor: 4.086