A Comparative Study of 2 doses of Botulinum Toxin A in Post Traumatic Trigeminal Neuropathic Pai

Phase 3

Recruiting

• Conditions: Post Traumatic Trigeminal Neuropathic Pain (PTTNP); Botulinum Toxin A; Post Traumatic Trigeminal Neuropathic Pain; Orofacial Pain; Neuropathic pain

• Registration Number: TCTR20210811001
• Lead Sponsor: euroscience Research and Development Group, Khon Kaen University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-11
• Study Completion: 2021-09-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

1. Diagnosed with PPTTN according to the diagnostic criteria of International Classification of Orofacial Pain (ICOP, 2020)
2. Age of 20 to 65 years old
3. Pain located intraorally, occurring unilaterally at the side of injury and is located at trigeminal nerve division of V2 and V3.
4. Patients experiencing pain score of more than or equal to 4 as measured by the Visual Analogue Scale (VAS) with continuous daily pain and those who do not respond to conventional pharmacotherapy within 3 months of treatment or has developed intolerable adverse reaction or detrimental systemic effects from medication
5. Presence of other neuropathic symptoms such as allodynia and numbness are included.
6. Participants are required to be in good general health
7.Participants who can read, write and have understood the information regarding about the trial and the possible complications.

Exclusion Criteria

1. Women who are pregnant or planning to be pregnant during the trial
2. The presence of other orofacial neuropathic conditions (e.g. Trigeminal neuralgia, Post herpetic neuralgia, etc) and headache.
3. Patients undergoing alternative treatment for PTTNP (e.g. acupuncture or herbal medicine)
4. Patients who have presence of infection at the injection site
5. Presence of medical conditions (e.g.motor neuropathic diseases and neuromuscular disorder) or use of any agent that might put patients at increased risk such as severe dysphagia and respiratory difficulties if exposed to BTX-A
6. Patients taking substances that might interfere with neuromuscular function
7. Having uncontrolled systemic condition such as those who suffer from coagulopathy or severe heart, liver, kidney, or other organ dysfunction
8. Patients with unstable mental illness and impaired cognitive.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain intensity baseline and after injection (2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks ) Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
safety and tolerability 30 mins after injection and throughout the trial adverse reaction checklist and daily pain diary,Pain quality baseline and after injection (2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks ) Neuropathic Pain Symptom Inventory (NPSI),Physical Functioning baseline and after injection (2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks ) Oral Health Impact Profile 14 ( OHIP-14),Emotional Functioning baseline and after injection (2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks ) Hospital Anxiety and Depression scores,Quality of Life baseline and after injection (2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 24 weeks ) EQ-5D-5L,Patient's Satisfaction and preference to treatment 12 weeks and 24 weeks after injection Patient's Global Impression of Change (PGIC),Onset and duration all throughout the trial Daily Pain Diary