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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Cervical Dystonia | Procedure: Clinical targeting Procedure: Ultrasonography targeting | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 132 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography |
Actual Study Start Date : | March 27, 2019 |
Actual Primary Completion Date : | April 14, 2020 |
Actual Study Completion Date : | April 14, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Clinical targeting
Clinical localization method (observation and palpation of target muscles)
|
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)
|
Experimental: Ultrasonography targeting
Ultrason-guided method
|
Procedure: Ultrasonography targeting
The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
|
Variation of the GCI-I (Clinical Global Impressions - Improvement) patient scale :
Variation of the TWSTRS-2 (Toronto Western Spasmodic Torticollis Rating Scale) : pain scale only
Total score = 0 (no pain) to 40 (maximal pain)
Variation of the TWSTRS-PSYCH (Toronto Western Spasmodic Torticollis Rating Scale - Psychiatric) scale
Total score = 0 (no psychiatric disorders) to 24 (important psychiatric disorders)
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindication of botulinum toxin injections as :
France | |
Hôpital Roger Salengro, CHRU de Lille - Service de neurologie A | |
Lille, France, 59037 |
Principal Investigator: | Alexandre KREISLER, MD, Ph | Hôpital Roger Salengro, CHRU Lille |
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | April 26, 2019 | ||||
First Posted Date ICMJE | May 10, 2019 | ||||
Last Update Posted Date | April 23, 2021 | ||||
Actual Study Start Date ICMJE | March 27, 2019 | ||||
Actual Primary Completion Date | April 14, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Cervical Dystonia Impact Profile 58 (CDIP-58) [ Time Frame: 1 month after inclusion ] Variation of the total score obtained with The Cervical Dystonia Impact Profile
|
||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
|
||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Targeting Methods of Botulinum Toxin Injections for Cervical Dystonia | ||||
Official Title ICMJE | Results of Botulinum Toxin Injections for Cervical Dystonia : Benefits of Ultrasonography | ||||
Brief 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. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Other |
||||
Condition ICMJE | Idiopathic Cervical Dystonia | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
132 | ||||
Original Estimated Enrollment ICMJE |
150 | ||||
Actual Study Completion Date ICMJE | April 14, 2020 | ||||
Actual Primary Completion Date | April 14, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03946046 | ||||
Other Study ID Numbers ICMJE | 2017_68 2018-A02045-50 ( Registry Identifier: ID-RCB ) |
||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | University Hospital, Lille | ||||
Study Sponsor ICMJE | University Hospital, Lille | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | University Hospital, Lille | ||||
Verification Date | April 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |