A Phase 2 interventional study of intraoral trigger point injection by botox and transcutaneous trigger point injection by botox in Myofacial Pain, sponsored by Fayoum University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by Fayoum University · Phase 2, Interventional, and Treatment
Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).
186 studies on the registry are indexed under Facial Pain; 58 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 136 interventional studies indexed under Facial Pain.
Browse Facial Pain studies →Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: transcutaneous trigger point injection by botox
Drug: intraoral trigger point injection by botox
intraoral injection of trigger point of masseter muscle by botulinum toxin
transcutaneous injection of masseter muscle by botulinum toxin
pain score
The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.
Time frame: 6 weeks post injection
(OHIP-14) scale
OHIP-14 is used to measure patients' self-reported discomfort, disability, and functional limitation due to oral conditions with scores ranging from 0 to 56 (with 56 representing a subject answering ''very often'' to all 14 items
Time frame: 6 weeks
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Fayoum University