Health TrialsbyHealthPanel

Botulinum Toxin Type A Versus Triamcinolone for Facial Myalgia

ConditionMyofascial Pain Syndrome (MPS)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-60
SponsorRiyadh Elm University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Neuromuscular disorders.

Pregnancy or breastfeeding.

Allergy to Botulinum Toxin or corticosteroids.

Refusal to provide informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Triamcinolone Acetonide

    Drug

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

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Arm 1 botulinum toxin type 1Experimental treatment 1 intervention
Group B: Arm 2 triamcinoloneActive comparator 1 intervention

Trial outcomes

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.

Time frame
2 weeks 4 weeks 6 weeks

Secondary outcomes

1

Headache

Headache-related impact will be assessed using the 6-item Headache Impact Test (HIT-6). Scores will be compared between the Botulinum Toxin Type A and triamcinolone groups.

Time frame
2 weeks 4 weeks 6 weeks after injection
2

Sleep quality

Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Scores will be compared between the Botulinum Toxin Type A and triamcinolone groups.

Time frame
2 weeks 4 weeks 6 weeks after injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riyadh Elm University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: