Intraoral Injection of Trigger Points by Botox

NCT05673655 | Unknown Phase 2 DMC

• 1 other identifier: EC2213
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Myofacial Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• (OHIP-14) scale

  6 weeks

Study Arms (2)

transcutaneous injection

ACTIVE COMPARATOR

Drug: transcutaneous trigger point injection by botox

intraoral injection

ACTIVE COMPARATOR

Drug: intraoral trigger point injection by botox

Interventions

intraoral trigger point injection by botox DRUG

intraoral injection of trigger point of masseter muscle by botulinum toxin

intraoral injection

transcutaneous trigger point injection by botox DRUG

transcutaneous injection of masseter muscle by botulinum toxin

transcutaneous injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University

Al Fayyum, Egypt

Location

Related Publications (1)

• Shabaan AA, Kassem I, Aboulmagd I, Amer IA, Shaaban A, Abd-El-Ghafour M, Refahee SM. Effectiveness of intra-oral botulinum toxin injection in comparison to the extra-oral approach on pain and quality of life in patients with myofascial pain: a randomized clinical trial. Clin Oral Investig. 2024 Dec 17;29(1):18. doi: 10.1007/s00784-024-06051-0.

  PMID: 39681752 DERIVED

MeSH Terms

Conditions

Facial Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 6, 2023
• Study Start: December 25, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 25, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

EG (1)