Botulinum Toxin Type A Versus Triamcinolone for Facial Myalgia

NCT07867379 | Not Yet Recruiting Phase 4

• 1 other identifier: FPGRP/2026/1004/1437/1390
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This single-blind randomized controlled trial aims to compare the therapeutic effects of Botulinum Toxin Type A and triamcinolone injections in adults with facial myofascial pain syndrome. A total of 56 participants will be randomly allocated in a 1:1 ratio to receive either Botulinum Toxin Type A or triamcinolone injection. The primary outcome will assess pain intensity using the Visual Analogue Scale (VAS). Secondary outcomes will evaluate headache symptoms and sleep quality. The study aims to determine the comparative effectiveness of the two interventions in reducing pain and improving patient-reported outcomes.

Conditions

Myofascial Pain Syndrome (MPS)

Keywords

Facial myalgia; Orofacial pain; Triamcinolone; Trigger point injection; Botulinum toxin type A

Outcome Measures

Primary Outcomes (1)

• Pain intensity measured by the visual analoge scale VAS

  using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. VAS scores will be compared between the Botulinum Toxin Type A and triamcinolone groups.

  2 weeks 4 weeks 6 weeks

Secondary Outcomes (2)

• Headache

  2 weeks 4 weeks 6 weeks after injection

• Sleep quality

  2 weeks 4 weeks 6 weeks after injection

Study Arms (2)

Arm 1 botulinum toxin type 1

EXPERIMENTAL

Participants randomized to this arm will receive Botulinum Toxin Type A injection for the management of facial myofascial pain syndrome.

Drug: Botulinum Toxin A (Botox )

Arm 2 triamcinolone

ACTIVE COMPARATOR

Participants randomized to this arm will receive triamcinolone injection for the management of facial myofascial pain syndrome.

Drug: Triamcinolone Acetonide

Interventions

Botulinum Toxin A (Botox ) DRUG

Botulinum Toxin Type A will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.

Arm 1 botulinum toxin type 1

Triamcinolone Acetonide DRUG

Triamcinolone acetonide will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.

Arm 2 triamcinolone

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 to 60 years.
• Diagnosed with Myofascial Pain Syndrome with active trigger points.
• Ability and willingness to provide informed consent and adhere to the study procedures.

You may not qualify if:

• Received any injection therapy within the past 6 months.
• Neuromuscular disorders.
• Pregnancy or breastfeeding.
• Allergy to Botulinum Toxin or corticosteroids.
• Refusal to provide informed consent.
• Current use of systemic corticosteroids or muscle relaxants.
• Individuals with disabilities who are unable to provide informed consent.

Sponsors & Collaborators

• Riyadh Elm University: lead

Study Sites (1)

Riyadh Elm University

Riyadh, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Facial Pain

Interventions

Botulinum Toxins, Type A; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Albatool Saad Alahmari, BDS

CONTACT

+966545510103; Albatool.alahmari2024@student.riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to treatment allocation. The clinician administering the injection is aware of the assigned intervention because the preparation and administration of the two treatments differ.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start (Estimated): October 11, 2026
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: October 9, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)