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

Completed

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

• Registration Number: NCT05103202
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

Study Timeline

• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-11-01
• Study First Posted: 2021-11-02
• Study Start: 2021-11-04
• Primary Completion: 2022-03-07
• Status Verified: 2022-06
• Study Completion: 2022-06-14
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of injection	single measure at 1 day of enrollment	Side effects recorded qualitatively and graded by severity (0 to 4 numerical subjective grade where 4 is most severe) by the injecting physician and attributed by that physician to the most recent injection
Quality of Life measured by Short Form 36 (SF-36)	single measure at 1 day of enrollment	SF-36 HRQoL score as collected by a patient-completed survey (measured from 0 to 100 with a scoring system where 100 is best quality of life)

Secondary Outcome Measures

Name	Time	Method
Blepharospasm disability index survey (BSDI)	single measure at 1 day of enrollment	Patient-completed survey BSDI- Disease specific quality of life score measured from 0 to 4 calculated as a mean of applicable items with 4 representing worst quality of life
Cervicocranial dystonia questionnaire (CDQ24)	single measure at 1 day of enrollment	Patient-completed survey CDQ24- Disease specific quality of life score measured from 0 to 100 with 100 representing worst quality of life
Arm Dystonia Disability Scale (ADDS)	single measure at 1 day of enrollment	Patient-completed survey ADDS- Disease specific quality of life score measured from 0 to 100% with 0% representing worst quality of life
Hemifacial Spasm Scale (HFS7)	single measure at 1 day of enrollment	Patient-completed survey HFS7- Disease specific quality of life score (measured from 0 to 4 where 4 is the most severe effect on quality of life)
Spasticity Quality of Life scale (SQoL-6D)	single measure at 1 day of enrollment	Patient-completed survey SQoL-6D- Disease specific quality of life score (measured from 0 to 100 with 100 representing best quality of life)
Oromandibular dystonia questionnaire (OMDQ-25)	single measure at 1 day of enrollment	Patient-completed survey OMDQ-25- Disease specific quality of life score (measured from 0 to 100 with 100 representing worst quality of life)

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States