Cervical dystonia is a condition that causes the neck muscles to tighten or spasm, leading to abnormal head positions and pain.
The main questions it aims to answer are:
* Do ultrasound-guided BoNT injections improve quality of life more than injections without ultrasound? * Are ultrasound-guided injections as safe as injections without ultrasound?
Researchers will compare:
* BoNT injections with ultrasound guidance * BoNT injections without ultrasound guidance (based only on body landmarks)
Participants will:
* Receive both types of injections during the study (one first, then the other) * Complete questionnaires about quality of life, movement, pain, and mood * Attend follow-up visits over about 8 months About 37 adults with cervical dystonia will take part. The study will take place at the Fondazione IRCCS Istituto Neurologico Carlo Besta in Milan, Italy.
Minimum age 18 years old
Clinical diagnosis of Idiopathic Cervical Dystonia
On a stable dose of other medications (if any) used for focal dystonia treatment (e.g. anticholinergics and benzodiazepines) for at least 3 months prior to screening and expected to be maintained throughout the study
Treatment non-naïve to BoNT type A therapy for CD
Diagnosis of other types of Cervical Dystonia (Inherited and Acquired)
Concomitant diagnosis of diseases that contraindicate the use of botulinum toxin, such as myasthenia gravis
Known hypersensitivity or allergy to Botulinum-A Toxin
Women who are pregnant or breast feeding
Crossover
Ultrasound-guided botulinum toxin injection
Procedure/SurgeryBotulinum toxin type A is injected into dystonic cervical muscles under real-time ultrasound guidance, allowing visualisation of target muscles and adjacent structures. Injections are performed according to standard clinical practice with a stable dose and scheme
Non-ultrasound-guided botulinum toxin injection
Procedure/SurgeryBotulinum toxin type A is injected into dystonic cervical muscles using anatomical landmarks, without ultrasound guidance. To maintain blinding, the ultrasound device is present in all procedures, but the screen is turned off in this arm. Injections are performed according to standard clinical practice with a stable dose and scheme
Change in Cervical Dystonia Impact Profile-58 (CDIP-58) score
Total score on the Cervical Dystonia Impact Profile (CDIP-58), a patient-reported outcome measure of quality of life in cervical dystonia. Score range: 0-100, with higher scores indicating greater impact on quality of life (worse outcome).
Change in Toronto Western Spasmodic Torticollis Rating Scale - 2 (TWSTRS-2)
Total score on the Toronto Western Spasmodic Torticollis Rating Scale, 2nd edition (TWSTRS-2), a clinician-rated scale assessing severity, disability, and pain in cervical dystonia. Score range: 0-100, with higher scores indicating greater severity, disability, or pain (worse outcome).
Change in Psychiatric Screening Tool (TWSTRS-PSYCH) score
The TWSTRS-PSYCH assesses psychiatric comorbidity associated with cervical dystonia. The total score ranges from \[inserire range corretto, es. 0-X\], with higher scores indicating greater psychiatric symptom severity (worse outcome).
Change in Hospital Anxiety and Depression Scale (HADS) score
The HADS is a 14-item self-administered questionnaire assessing anxiety and depressive symptoms. The total score ranges from 0 to 42, with higher scores indicating greater anxiety and depressive symptom severity (worse outcome). Each subscale (HADS-A and HADS-D) ranges from 0 to 21, with higher scores indicating worse symptoms.
Change in Pain Numerical Rating Scale (NRS) score
Pain intensity is assessed using the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). The outcome measure is the change in NRS score from baseline to 6 weeks after each injection in both crossover periods. Higher scores indicate greater pain severity (worse outcome).
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