Myofascial Pain SyndromePhase 2NCT06975813
Magnesium Sulfate and Trigger Points
A Phase 2 study testing masseter muscle and masseter and sternocleidomastoid muscle in people with Myofascial Pain Syndrome, run by Fayoum University.
Trial summary
The patients will be randomly assigned to one of the two groups according to the treatment method: group I (masseter group) and group II (masseter \&sternocleidomastoid group) where each patient will be injected 0.5ml in each trigger point (TrPs) of magnesium sulphate according to the treatment group by the same… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pain Syndrome
- What is being tested?
- masseter muscle and masseter and sternocleidomastoid muscle
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 27 Jan 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- definite diagnosis of myofascial pain
- presence of one or more unilateral or bilateral trigger points in the masseter muscle and sternocleidomastoid muscle;
- no history of any invasive procedures of the related masseter muscle.
Who cannot join
- any painful conditions (other than myofascial trigger points) affecting the orofacial region
- any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy);
- pregnancy and lactation
About this study
Official title: Efficacy of Isolated Masseter Versus Masseter- Sternocleidomastoid Trigger Points Injection by Magnesium Sulfate for Myofacial Pain
The patients will be randomly assigned to one of the two groups according to the treatment method: group I (masseter group) and group II (masseter \&sternocleidomastoid group) where each patient will be injected 0.5ml in each trigger point (TrPs) of magnesium sulphate according to the treatment group by the same operator. The treatment method for TrPs will be the primary predictor variable. Patients will be examined at the following intervals: during diagnosis, 1-month, 3-months, and 6-months post-injection. The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever
- Conditions
- Myofascial Pain Syndrome
- Being tested
- masseter muscle, masseter and sternocleidomastoid muscle
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
masseter muscleDrug
masseter muscle trigger points injection by magnesium sulphate
masseter and sternocleidomastoid muscleDrug
masseter and sternocleidomastoid muscle trigger points injection by magnesium sulphate
| Study group | Role | What they receive |
|---|---|---|
| masseter muscle | Active comparator | Not described Receives: Drug: masseter muscle |
| masseter and sternocleidomastoid muscles | Experimental | Not described Receives: Drug: masseter and sternocleidomastoid muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle pain
by visual analogue scal
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion27 Jan 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 SyndromeStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Mohsen, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975813
- Sponsor's protocol ID
- 1111
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Isolated Masseter Versus Masseter- Sternocleidomastoid Trigger Points Injection by Magnesium Sulfate for Myofacial Pain
- ClinicalTrials.gov ID
- NCT06975813
- Acronym / sponsor ID
- 1111
- Conditions
- Myofascial Pain Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 27 Jan 2026 (estimated)
- First posted
- 16 May 2025 (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.
The patients will be randomly assigned to one of the two groups according to the treatment method: group I (masseter group) and group II (masseter \&sternocleidomastoid group) where each patient will be injected 0.5ml in each trigger point (TrPs) of magnesium sulphate according to the treatment group by the same operator. The treatment method for TrPs will be the primary predictor variable. Patients will be examined at the following intervals: during diagnosis, 1-month, 3-months, and 6-months post-injection. The participated patients will be assessed using pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| masseter muscle | Active comparator | Drug: masseter muscle |
| masseter and sternocleidomastoid muscles | Experimental | Drug: masseter and sternocleidomastoid muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- definite diagnosis of myofascial pain
- presence of one or more unilateral or bilateral trigger points in the masseter muscle and sternocleidomastoid muscle;
- no history of any invasive procedures of the related masseter muscle.
Key exclusion criteria (3 listed)
- any painful conditions (other than myofascial trigger points) affecting the orofacial region
- any systemic diseases that could masticatory function (e.g., rheumatoid arthritis and epilepsy);
- pregnancy and lactation
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 |
|---|---|---|
| masseter musclemasseter muscle trigger points injection by magnesium sulphate | Drug | masseter muscle |
| masseter and sternocleidomastoid musclemasseter and sternocleidomastoid muscle trigger points injection by magnesium sulphate | Drug | masseter and sternocleidomastoid muscles |
Primary outcome
muscle pain
Time frame: 6 months
by visual analogue scal
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 16 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing masseter muscle and masseter and sternocleidomastoid muscle in people with Myofascial Pain Syndrome, run by Fayoum University.
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 3 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 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
muscle pain (time frame: 6 months). 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 16 May 2025.