Intraoral Injection of Trigger Points by Botox

Myofacial Pain Clinical Trial

Official title:

Evaluation of Ultrasound Sonography Intraoral Guided Injection of Botulinum Toxin in Masseter Muscle

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05673655
• Other study ID #: EC2213
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: December 25, 2022
• Est. completion date: February 25, 2023

Study information

• Verified date: January 2023
• Source: Fayoum University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: February 25, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Definite diagnosis of myofascial pain with a referral

• the presence of one or more trigger points in the unilateral or bilateral masseter muscle -

• no history of any invasive procedures in the related masseter muscle

Exclusion Criteria:

• Factors that can cause pain in the orofacial region other than trigger points (decayed tooth, temporomandibular joint internal disorder).

• Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy

• pregnancy and lactation.

Related Conditions & MeSH terms

• Facial Pain
• Myofacial Pain

Intervention

Drug:
• intraoral trigger point injection by botox
intraoral injection of trigger point of masseter muscle by botulinum toxin
• transcutaneous trigger point injection by botox
transcutaneous injection of masseter muscle by botulinum toxin

Locations

Country	Name	City	State
Egypt	Fayoum University	Fayoum

Sponsors (1)

Lead Sponsor	Collaborator
Fayoum University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks post injection
Secondary	(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	6 weeks