Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin

NCT ID: NCT05103202

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-04
• Study Completion Date: 2022-06-14

Brief 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.

Detailed 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.

Conditions

Cervical Dystonia; Blepharospasm; Limb Dystonia; Hemifacial Spasm; Spasticity, Muscle; Fragments of Torsion Dystonia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

10 weeks or less

Patients receiving botulinum toxin injections at a frequency of 10 weeks or less

No interventions assigned to this group

12 weeks or more

Patients receiving botulinum toxin injections at a frequency of 12 weeks or more

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Aim 1:

1. Patient provides responses to an internet based survey which includes consent to participate

2. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study

3. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators

4. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more

Aim 2:

1. Patient provides responses to an internet based survey which includes consent to participate

2. Patient has been diagnosed with one or more of the conditions for which a HRQoL scale exists and will be employed in this study

3. Patient has received at least 2 prior injections with botulinum toxin for that condition by one of the study investigators

4. Both of the two most recent intervals between injections are either a) 10-weeks or less or b) 12-weeks or more

5. If receiving injections at 12-weeks or more, notes must have previously indicated that patient needs an injection interval of 10-weeks or less

6. If receiving injections at 12-weeks or more, the reason must be that the insurance carrier covering that patient's medical costs refused to allow a 10-week or less injection frequency

Exclusion Criteria

For both Aims 1 and 2:

1. Patient is unwilling to consent to study procedures (refuses to fill out surveys)

2. Patient has variable injection frequencies such that the two most recent injections do not both meet criteria of being 10-weeks or less in frequency or 12-weeks or more in frequency

3. Patient has a diagnosis of and is being treated for a condition for which a HRQoL scale does not exist

4. Patient has insufficient chart documentation to characterize demographics, diagnosis, toxin selected, dose used, and injection frequency employed

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard Dewey

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard B Dewey, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center

Locations

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

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Other Identifiers

STU-2021-0224

Identifier Type: -

Identifier Source: org_study_id