Trials / Completed
CompletedNCT03946046
Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia
Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- University Hospital, Lille · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Botulinum toxin injections are the treatment of choice for cervical dystonia. Even if this treatment is successful for most of the patients, partials or completes failures still remained. Usually, botulinum toxin injections are realized by clinical localization techniques (observation and palpation of target muscles). The use of Ultrasonography to guide injections of Botulinum toxin has theoretical benefits (as an improved precision, an improved reproducibility, the targeting of deep-seated muscles, and a lower risk of adverse events) but its interest has never been demonstrated.
Detailed description
Open label non-randomised controlled clinical trial comparing clinical localization techniques and ultrasonography to guide injections of Botulinum toxin A. The primary outcome is to compare both techniques of injection regarding to the health impact of cervical dystonia (CDIP-58) measured 1 month after injection. The results of this clinical trial will help the clinician to decide which strategy of injection is the most effective in terms of benefit/risk ratio to treat the cervical dystonia.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Clinical targeting | The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles) |
| PROCEDURE | Ultrasonography targeting | The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method |
Timeline
- Start date
- 2019-03-27
- Primary completion
- 2020-04-14
- Completion
- 2020-04-14
- First posted
- 2019-05-10
- Last updated
- 2021-04-23
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03946046. Inclusion in this directory is not an endorsement.