N/A
Completed N=20
Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia
Spasticity · Focal Dystonia · Tremor, Limb
Source: ClinicalTrials.gov NCT02334683 ↗
Enrolled (actual)
20
Serious AEs
2.6%
Results posted
Nov 2021
Primary outcomePrimary: Change in Patient Global Impression of Change — 53.1; 51.5 score on a scale
Summary
This study seeks to compare the use of ultrasound and electrophysiologic techniques to target muscles for the treatment of spasticity and focal dystonia of the limbs. The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity. Electrophysiologic guidance, using electrical stimulation, and ultrasound are the standard ways of locating muscles during a treatment of BoNT injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Patient Global Impression of Change |
53.1; 51.5 | — |
| SECONDARY Change in Visual Analog Scale |
54.72; 52.37 | — |
| SECONDARY Change in Muscle Strength |
29.89; 20.63 | — |
Eligibility Criteria
Inclusion Criteria
- 18 years or older
- Confirmed diagnosis of focal upper extremity dystonia (FHD) or upper limb spasticity
- Stable onabotulinumtoxinA dose regimen with a stable response as judged by the physician and patient for at least 2 treatment sessions.
Exclusion Criteria
- Contraindications to botulinum toxin
- Pregnancy or nursing
- Cognitive impairment that prevents reliable outcome measures of self-report
Data sourced from ClinicalTrials.gov (NCT02334683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.