Myofascial Pain Syndrome (MPS)Phase 4NCT07867379
Botulinum Toxin Type A Versus Triamcinolone for Facial Myalgia
A Phase 4 study testing Botulinum Toxin A (Botox ) and Triamcinolone Acetonide in people with Myofascial Pain Syndrome (MPS), run by Riyadh Elm University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Myofascial Pain Syndrome (MPS)
- What is being tested?
- Botulinum Toxin A (Botox ) and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 11 Oct 2026to 24 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Albatool Saad Alahmari, BDS contact
About this study
Official title: Comparison of the Therapeutic Effects of Botulinum Toxin Type A and Triamcinolone Injection in Managing Facial Myalgia: A Single Blind Randomized Controlled 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.
- Conditions
- Myofascial Pain Syndrome (MPS)
- Being tested
- Botulinum Toxin A (Botox ), Triamcinolone Acetonide
- Keywords
- Facial myalgia, Orofacial pain, Triamcinolone, Trigger point injection, Botulinum toxin type A
- Medical subject headings
- Myofascial Pain Syndromes, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 AcetonideDrug
Triamcinolone acetonide will be administered by injection into the affected masticatory muscle trigger points according to the study protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks 4 weeks 6 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 2 weeks 4 weeks 6 weeks after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start11 Oct 2026 (estimated)
- Primary completion24 Dec 2026 (estimated)
- Study completion24 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome (MPS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riyadh Elm University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albatool Saad Alahmari, Riyadh Elm University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07867379
- Sponsor's protocol ID
- FPGRP/2026/1004/1437/1390
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Therapeutic Effects of Botulinum Toxin Type A and Triamcinolone Injection in Managing Facial Myalgia: A Single Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07867379
- Acronym / sponsor ID
- FPGRP/2026/1004/1437/1390
- Conditions
- Myofascial Pain Syndrome (MPS)
- Keywords
- Facial myalgia, Orofacial pain, Triamcinolone, Trigger point injection, Botulinum toxin type A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Riyadh Elm UniversityUniversity, hospital or other
- Study start
- 11 Oct 2026 (estimated)
- Primary completion
- 24 Dec 2026 (estimated)
- Study completion
- 24 Dec 2026 (estimated)
- First posted
- 9 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 botulinum toxin type 1 | Experimental | Drug: Botulinum Toxin A (Botox )Participants randomized to this arm will receive Botulinum Toxin Type A injection for the management of facial myofascial pain syndrome. |
| Arm 2 triamcinolone | Active comparator | Drug: Triamcinolone AcetonideParticipants randomized to this arm will receive triamcinolone injection for the management of facial myofascial pain syndrome. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin A (Botox )Botulinum Toxin Type A will be administered by injection into the affected masticatory muscle trigger points according to the study protocol. | Drug | Arm 1 botulinum toxin type 1 |
| Triamcinolone AcetonideTriamcinolone acetonide will be administered by injection into the affected masticatory muscle trigger points according to the study protocol. | Drug | Arm 2 triamcinolone |
Primary outcome
Pain intensity measured by the visual analoge scale VAS
Time frame: 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.
2 secondary outcomes
Headache
Time frame: 2 weeks 4 weeks 6 weeks after injection
Sleep quality
Time frame: 2 weeks 4 weeks 6 weeks after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Albatool Saad Alahmari, BDS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum Toxin A (Botox ) and Triamcinolone Acetonide in people with Myofascial Pain Syndrome (MPS), run by Riyadh Elm University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Albatool Saad Alahmari, BDS (+966545510103 ext. 000, Albatool.alahmari2024@student.riyadh.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by the visual analoge scale VAS (time frame: 2 weeks 4 weeks 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.