Clinical Trials Logo

Clinical Trial Summary

Our hypothesis is that botulinum toxin injections (with onabotulinum toxin, incobotulinum toxin, and abobotulinum toxin) given at 10-week or shorter intervals for the indication of treatment of muscle spasms associated with neurological disorders are associated with equal safety and effectiveness as those given at 12-week or longer intervals. We also hypothesize that for those patients who would prefer a shorter inter-injection interval, but for whom their insurance carrier has prevented this, have worse health-related quality of life compared to patients who receive injections at a 10-week or shorter interval. We aim to investigate this hypothesis by collecting demographic and injection data and patient survey responses.


Clinical Trial Description

Our project has the following aims: Aim 1: to determine if any difference exists in safety or efficacy between patients receiving injections of botulinum toxin at 10-week or shorter intervals as compared to patients receiving injections at 12-week or longer intervals. Aim 2: to determine if patients who have expressed a preference for injections at 10 week or shorter intervals but whose insurance carriers have mandated a 12-week interval have worse health related quality of life as compared to patients who are receiving injections at 10-week or shorter intervals. This project consists of two analyses, each designed to accomplish aims 1 and 2. For both aims, we will invite consecutive patients who meet entry criteria to participate who are followed in the botulinum toxin injection clinics of the University of Texas Southwestern Medical Center movement disorders faculty. Participants who consent to data collection by participating in an email-administered survey of quality of life will have their medical records reviewed by an investigator for abstraction of clinical data (to include dose, injection site, injection interval, side effects, demographics, and diagnoses). Additionally, patients will fill out two or more survey instruments on the date of their enrollment visit following their botulinum toxin injection visit. The survey instruments completed will be 1) the SF-36 health questionnaire and 2) a disease-specific HRQoL survey chosen to be applicable to the specific condition for which that subject is receiving botulinum toxin injections. Patients receiving injections for multiple conditions will receive surveys for each condition for which they are receiving treatment. The disease specific scales to be used selectively depending on the patient's specific condition include: - Blepharospasm disability index - Craniocervical dystonia questionnaire (CDQ-24) - Arm dystonia disability scale (ADDS) - Hemifacial spasm scale (HSF-7) - Oromandibular dystonia questionnaire (OMDQ-25) - Spasticity scale (SQoL-6D) For analysis, patients will be segregated into two groups (10-week or shorter inter-injection interval and 12 week or longer inter-injection interval) on the basis of time elapsed between the most recent botulinum toxin treatments. Clinical and survey data will be analyzed to determine if differences exist between the two groups. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05103202
Study type Observational
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase
Start date November 4, 2021
Completion date June 14, 2022

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT03908580 - MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity Phase 4
Not yet recruiting NCT04550793 - Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
Active, not recruiting NCT05562453 - Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain N/A
Recruiting NCT06214975 - EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2) N/A
Recruiting NCT05464160 - Focal Muscular Vibration in Patients With Severe Acquired Brain Injury N/A
Completed NCT04130295 - Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury N/A
Recruiting NCT06070233 - Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy N/A
Completed NCT03747900 - Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity N/A
Completed NCT03307135 - Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity N/A
Recruiting NCT05070780 - Neurophysiological Evaluation of Muscle Tone
Recruiting NCT04620707 - RGS@Home: Personalized 24/7 Home Care Post-stroke N/A
Recruiting NCT06109129 - Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy N/A
Enrolling by invitation NCT05598736 - Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain N/A
Active, not recruiting NCT05626790 - Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow N/A
Recruiting NCT04904016 - Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity N/A
Withdrawn NCT05887479 - The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity Phase 4
Completed NCT03442660 - Validation of the Spasticity Related Quality of Life Questionnaire N/A