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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intradermal / submucosal injection group | Active Comparator | intradermal / submucosal injection at pain area |
|
| intra-masseter injection group | Experimental | intra-masseter injection on the ipsilateral of pain involved |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Toxin type A (intradermal / submucosal injection at pain area) | Drug | Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief | 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 | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 1 week |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache |
| Measure | Description | Time Frame |
|---|---|---|
| Safety which is assessed by adverse reactions | Adverse reactions | 12 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chuanjie Wu, MD | Contact | 008615903676787 | wuchuanjie8557@163.com | |
| Yajun Lian, MD | Contact | 008613838367143 | lianyajun369@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Chuanjie Wu, MD | Xuanwu Hospital Captial Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital Captial Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D007271 | Injections, Intradermal |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved) | Drug | Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia |
|
| 2 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 3 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 4 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 5 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 6 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 7 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 8 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 9 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 10 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 11 weeks |
| Visual Analogue Scale score | Visual Analogue Scale score is an 11 point scale from 0 - 10 with 0 being no headache | 12 weeks |
| The overall response to treatment on the Patient Global Impression of Change | 8 weeks |
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| Xiangtan Central Hospital | Recruiting | Xiangtan | Hunan | China |
|
| Luzhou People's Hospital | Recruiting | Luzhou | Sichuan | China |
|
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D007279 | Injections, Subcutaneous |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |