A Phase 4 interventional study of Botulinum Toxin A (Botox ) and Triamcinolone Acetonide in Myofascial Pain Syndrome (MPS), sponsored by Riyadh Elm University. Not yet recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Riyadh Elm University · Phase 4, Interventional, and Treatment
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.
1,143 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's planned enrollment of 56 is close to the median of 60 across 937 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Riyadh Elm University is the lead sponsor of 26 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
Received any injection therapy within the past 6 months.
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 )
Participants randomized to this arm will receive triamcinolone injection for the management of facial myofascial pain syndrome.
Drug: Triamcinolone Acetonide
Botulinum Toxin Type A will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.
Triamcinolone acetonide will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.
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
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
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
Plan to share: No — Individual participant data will not be shared with external researchers. Study data will be kept confidential and accessible only to authorized members of the research team. Anonymized data may be accessed by the independent statistician and Data Monitoring Officer for study-related purposes.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Riyadh Elm University