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

June 28, 2022 updated by: Richard Dewey, University of Texas Southwestern Medical Center

Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin for the Treatment of Muscle Spasm Associated With Neurological Disorders

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

105

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients will be recruited consecutively on presentation for treatment of muscle spasm due to neurological disease with botulinum toxin to the UT Southwestern Movement Disorders clinic by one of the investigators.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
10 weeks or less
Patients receiving botulinum toxin injections at a frequency of 10 weeks or less
12 weeks or more
Patients receiving botulinum toxin injections at a frequency of 12 weeks or more

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Life measured by Short Form 36 (SF-36)
Time Frame: 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)
single measure at 1 day of enrollment
Safety of injection
Time Frame: 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
single measure at 1 day of enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blepharospasm disability index survey (BSDI)
Time Frame: 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
single measure at 1 day of enrollment
Cervicocranial dystonia questionnaire (CDQ24)
Time Frame: 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
single measure at 1 day of enrollment
Arm Dystonia Disability Scale (ADDS)
Time Frame: 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
single measure at 1 day of enrollment
Hemifacial Spasm Scale (HFS7)
Time Frame: 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)
single measure at 1 day of enrollment
Oromandibular dystonia questionnaire (OMDQ-25)
Time Frame: 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)
single measure at 1 day of enrollment
Spasticity Quality of Life scale (SQoL-6D)
Time Frame: 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)
single measure at 1 day of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Richard B Dewey, Jr., MD, UT Southwestern Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2021

Primary Completion (Actual)

March 7, 2022

Study Completion (Actual)

June 14, 2022

Study Registration Dates

First Submitted

October 21, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2021-0224

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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