Myofascial Pain Syndrome (MPS)
Conditions
Keywords
Facial myalgia, Orofacial pain, Triamcinolone, Trigger point injection, Botulinum toxin type A
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.
Interventions
Botulinum Toxin Type A will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.
DRUGTriamcinolone Acetonide
Triamcinolone acetonide will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.
Sponsors
Riyadh Elm University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: * 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity measured by the visual analoge scale VAS | 2 weeks 4 weeks 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Headache | 2 weeks 4 weeks 6 weeks after injection | 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. |
| Sleep quality | 2 weeks 4 weeks 6 weeks after injection | 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. |
Countries
Saudi Arabia
Contacts
CONTACTAlbatool Saad Alahmari, BDS
Outcome results
None listed