The Use of Botulinum Toxin in the Management of Myofascial Pain Syndrome

NCT06824324 | Completed Phase 1 DMC

• 1 other identifier: 1004125
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to assess the efficacy of Botulinum toxin type (A) (BoNTA) injection in Myofascial pain syndrome management in the terms of duration of function improvement and pain reduction. Material and methods: Fourteen patients with Myofascial pain syndrome related to masticatory muscles were presented with trismus, pain and impairment of oral function. Treatment plan was established by utilizing thirty units of Botulinum toxin type (A) which was injected into masseter and sometimes temporalis muscle.

Conditions

Myofacial Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Pain level

  Pain level was assessed before the initiation of treatment and at 2, 8 and 16 weeks after injection by using the visual analogue scale

  16 weeks

Secondary Outcomes (1)

• Mouth opening

  16 weeks

Study Arms (1)

injection of Botulinum toxin A in Triger zone

ACTIVE COMPARATOR

The method utilized for dilution of Botulinum toxin A involved addition of 2.5ml of normal saline to 100 unit of Botox vial, and addition of 1.25ml to 50U of Botox so each 0.1ml contain 4U of Botox. Botox can be denatured easily so the dilution process was very precise and the dilute injected gently in to Botox Vial. A thirty units of Botulinum toxin A was injected intramuscularly bilaterally (30 U for each side) in thirteen patients and unilaterally in one patient

Drug: intramuscular Botulinum Toxin

Interventions

intramuscular Botulinum Toxin DRUG

A thirty units of Botulinum toxin A was injected intramuscularly in Triger zone of patient with myofascial pain syndrome

injection of Botulinum toxin A in Triger zone

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with myofascial pain related to the muscles of mastication (masseter and temporalis muscle).
• Patient with regional pain.
• Patient with or without limited mouth opening (trismus).
• Presence of trigger points within the identified masticatory muscles.

You may not qualify if:

• \- 1. Hypersensitivity to Botulinum toxin. 2. Active infection in the virtual points of injection. 3. Patient with generalized musculoskeletal pain as in Fibromyalgia Syndrome (FMS).
• \. Children younger than 12 years old and pregnant woman. 5-Patient recently undergone to one other modality of treatment

Sponsors & Collaborators

• Yassir R. Al-khannaq: lead

Study Sites (1)

College Of Dentistry University Of Baghdad

Baghdad, Iraq

Location

MeSH Terms

Conditions

Facial Neuralgia

Condition Hierarchy (Ancestors)

Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: LECTURER Dr.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 13, 2025
• Study Start: March 12, 2024
• Primary Completion: November 4, 2024
• Study Completion: January 6, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Locations

IR (1)