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Clinical Trials/TCTR20210811001
TCTR20210811001
Recruiting
Phase 3

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

euroscience Research and Development Group, Khon Kaen University0 sites46 target enrollmentAugust 11, 2021

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Post Traumatic Trigeminal Neuropathic Pain (PTTNP)
Sponsor
euroscience Research and Development Group, Khon Kaen University
Enrollment
46
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 11, 2021
End Date
September 15, 2021
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
euroscience Research and Development Group, Khon Kaen University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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