Botulinum Toxin for Trigeminal Neuralgia
- Conditions
- Trigeminal Neuralgia
- Interventions
- Drug: Botulinum Toxin type A (intradermal / submucosal injection at pain area)Drug: Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)
- Registration Number
- NCT03331913
- Lead Sponsor
- The First Affiliated Hospital of Zhengzhou University
- Brief Summary
Trigeminal neuralgia (TN) is one of the most painful and common types of neuropathic pain encountered by clinicians. It is typically treated pharmacologically with anticonvulsants,but these can be ineffective, or can lose their effectiveness over time.Botulinum toxin type A (BoNT-A) is an exotoxin released by the Gram-positive, anaerobic bacillus Clostridium botulinum that causes flaccid paralysis by blocking neurotransmitter release by axonal terminals. As a contaminant, it is the cause of potentially lethal botulism poisoning; however, as a drug, it has been widely used in the treatment of dystonia, as well as for non-surgical cosmetic treatment. More recently, studies investigating the ability of BoNT-A to treat pain have been increasing. In 2012, the investigators reported the results of a randomized, double-blind, and placebo-controlled trial in which subcutaneous injection of BoNT-A at the site of pain provided long-term effective relief in TN. The investigators noted that adverse effects were mild, as well. Other studies on TN have estimated the effectiveness of BoNT-A treatment in TN to be 47-73%. However, BoNT-A treatment is still ineffective in more than 30% of patients.In this study, the investigators investigate whether different treatment methods have different efficacy and safety.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Age >18 years
- Clinical diagnosis of classical trigeminal neuralgia according to the ICHD III (beta)
- The pain involved the gingiva
- Signed informed consent prior to entering study
- comorbid diseases that may be exacerbated by botulinum toxin type A (e.g., myasthenia gravis, motor neuron disease, or Lambert-Eaton syndrome).
- receiving drugs with neuromuscular junction toxicity 1 week before botulinum toxin type A treatment (e.g. quinine, aminoglycosides or penicillamine)
- had an infection of the skin or mucosa at any of the injection sites.
- psychiatric illness.
- malignancy.
- pregnancy or lactation.
- currently participating or previously participated in any investigational drug or device study within 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intradermal / submucosal injection group Botulinum Toxin type A (intradermal / submucosal injection at pain area) intradermal / submucosal injection at pain area intra-masseter injection group Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) intra-masseter injection on the ipsilateral of pain involved
- Primary Outcome Measures
Name Time Method Pain relief 4 weeks Pain relief was defined as ≥50% reduction in Visual Analogue Scale score which is an 11 point scale from 0 - 10 with 0 being no headache
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale score 12 weeks Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache
The overall response to treatment on the Patient Global Impression of Change 8 weeks
Trial Locations
- Locations (5)
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Guizhou Provincial People's Hospital
🇨🇳Guiyang, Guizhou, China
Xuanwu Hospital Captial Medical University
🇨🇳Beijing, Beijing, China
Xiangtan Central Hospital
🇨🇳Xiangtan, Hunan, China
Luzhou People's Hospital
🇨🇳Luzhou, Sichuan, China