Myofascial Pain Dysfunction SyndromeNCT07390851
Magnesium Sulfate as an Adjuvant to Lidocaine in MPDS Trigger Point Injections Assessed by VAS and sEMG.
A study testing Lidocaine 2% (preservative-free, without vasoconstrictor) and Lidocaine 2% + Magnesium Sulfate 10% (combination) in people with Myofascial Pain Dysfunction Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
Two groups of patients diagnosed with Myofascial Pain Dysfunction Syndrome (MPDS) will be included in this study. One group will receive trigger point injections of lidocaine alone. The other group will receive trigger point injections of lidocaine combined with magnesium sulfate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myofascial Pain Dysfunction Syndrome
- What is being tested?
- Lidocaine 2% (preservative-free, without vasoconstrictor) and Lidocaine 2% + Magnesium Sulfate 10% (combination)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Nov 2025to 26 Nov 2026
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Clinical diagnosis of Myofascial Pain Dysfunction Syndrome (MPDS).
- Presence of active myofascial trigger points in accessible muscles (e.g., masseter, temporalis, upper trapezius).
- Pain duration ≥ 3 months.
- Pain intensity ≥ 4 on the Visual Analog Scale (VAS).
- Noprior trigger point injection in the affected area within the past 3 months.
- Ability and willingness to provide informed consent.
- Compliance with study visits and procedures
Who cannot join
- Known allergy or hypersensitivity to Lidocaine, Magnesium Sulfate, or related agents.
- Current use of anticoagulants or history of bleeding disorders.
- Systemic or local infection at or near the injection site.
- History of fibromyalgia, central pain syndromes, or cancer-related pain.
- Major psychiatric illnesses (e.g., schizophrenia, severe depression).
- Recent surgery or trauma to the head, neck, or upper back (<6 months).
- Use of analgesics (NSAIDs, opioids) within 5 days before intervention.
- Severe systemic diseases:- Uncontrolled diabetes mellitus- Liver or kidney failure- Severe cardiovascular conditions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Khaled A Elhayes, PhD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of oral and dental medicine, cairo university
Giza, Giza Governorate, 12613
Maii E Abdelazeem, BSc, 01013988933, Maii.emad@dentistry.cu.edu.eg
Khaled A Elhayes, Phd
About this study
Official title: Evaluation of the Effect of Adding Magnesium Sulfate to Lidocaine in the Treatment of Myofascial Pain Dysfunction Syndrome Using Surface Electromyography (sEMG).(Randomized Clinical Trial)
Two groups of patients diagnosed with Myofascial Pain Dysfunction Syndrome (MPDS) will be included in this study. One group will receive trigger point injections of lidocaine alone. The other group will receive trigger point injections of lidocaine combined with magnesium sulfate. The study aims to compare the effectiveness of both treatments in reducing pain and improving muscle function. Patients will be assessed using a pain scale (VAS) and surface electromyography (sEMG) to measure muscle activity.
Read the detailed description
This randomized clinical trial aims to evaluate whether adding magnesium sulfate to lidocaine in trigger point injections provides better pain relief and muscle relaxation in patients with Myofascial Pain Dysfunction Syndrome (MPDS) compared to lidocaine alone.
Participants diagnosed with MPDS will be randomly assigned into one of two groups:
Group 1 (Control Group): Trigger point injection of lidocaine 2% Group 2 (Intervention Group): Trigger point injection of lidocaine 2% combined with magnesium sulfate 10% Each participant will receive injections in the identified myofascial trigger points. Pain during injection and after injection will be assessed using the Visual Analog Scale (VAS). Muscle activity will be measured using surface electromyography (sEMG) at specific time points during rest and muscle contraction.
The study will compare the changes in pain scores and EMG readings between the two groups to determine whether magnesium sulfate enhances the analgesic and muscle-relaxing effects of lidocaine. The results of this study may help improve treatment strategies for MPDS and provide evidence for using magnesium sulfate as an adjuvant to lidocaine in trigger point injections.
- Conditions
- Myofascial Pain Dysfunction Syndrome
- Being tested
- Lidocaine 2% (preservative-free, without vasoconstrictor), Lidocaine 2% + Magnesium Sulfate 10% (combination)
- Keywords
- Trigger points injection, Myofascial Pain Dysfunction Syndrome (MPDS), Magnesium Sulfate, Surface Electromyography, Visual Analog Scale
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 2% (preservative-free, without vasoconstrictor)Drug
Using 25-27G sterile disposable needle, intramuscular injection of 2%preservative-free solution of lidocaine without vasocostrictor, 1.8 ml at the most painful trigger points with "Fast-in, fast out" or "peppering" method and inject the solution slowly.
Lidocaine 2% + Magnesium Sulfate 10% (combination)Drug
Using 25-27G sterile disposable needle, intramuscular injection of 2%preservative-free solution of lidocaine without vasocostrictor mixed with 10%magnesium sulphate , Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄) at the most painful trigger points with "Fast-in, fast out" or "peppering" method and inject the solution slowly.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine injection | Active comparator | 2%preservative-free without vasocostrictor injectable solution, 1.8 ml per injection point. Receives: Drug: Lidocaine 2% (preservative-free, without vasoconstrictor) |
| Injection of Magnesium sulfate with Lidocaine | Experimental | 10% injectable solution (100 mg/ml), from certified supplier. Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄) Receives: Drug: Lidocaine 2% + Magnesium Sulfate 10% (combination) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction.
Pain intensity will be assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10 cm, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: Baseline, 1week, 2 weeks post-injection.
Muscle activity improvement.
Muscle activity will be assessed using surface electromyography (sEMG) by measuring Maximum Voluntary Contraction (MVC) in microvolts (µV). Higher values indicate improved muscle activity.
Measured: Baseline, 1 week, 2 weeks post-injection
Secondary outcomes (1)
Pain experienced during injection
Pain during injection will be assessed immediately after injection using the Visual Analogue Scale (VAS) ranging from 0 to 10 cm, where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: Immediately after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start26 Nov 2025
- Primary completion26 Nov 2026 (estimated)
- Study completion26 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myofascial Pain Dysfunction SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. Group 1 will receive lidocaine trigger point injections, while Group 2 will receive lidocaine combined with magnesium sulfate. Outcomes will be assessed at predefined follow-up visits using VAS and surface EMG.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maii Emad Abdelazeem, Cairo University
- Investigators
- Maii E Abdelazeem, Bsc, Principal investigator, Faculty of Oral & Dental Medicine, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390851
- Sponsor's protocol ID
- CU-OMFS-MPDS-TP-2025
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This is an academic thesis-based study, and the data contain sensitive personal and clinical information. Data access is restricted by institutional policies and ethical approval requirements. De-identified aggregate results will be reported in publications.
Publications
Leitch J, Webb A, Pudwell J, Chamberlain S, Henry R, Nitsch R. Magnesium-Based Trigger Point Infiltrations Versus Local Anaesthetic Infiltrations in Chronic Pelvic Myofascial Pain: A Randomized, Double-Blind, Controlled Study. J Obstet Gynaecol Can. 2022 Aug;44(8):877-885. doi: 10.1016/j.jogc.2022.02.129. Epub 2022 Mar 24.
PubMed 35339694Refahee SM, Mahrous AI, Shabaan AA. Clinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical study. BMC Oral Health. 2022 Sep 19;22(1):408. doi: 10.1186/s12903-022-02452-3.
PubMed 36123724
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Adding Magnesium Sulfate to Lidocaine in the Treatment of Myofascial Pain Dysfunction Syndrome Using Surface Electromyography (sEMG).(Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07390851
- Acronym / sponsor ID
- CU-OMFS-MPDS-TP-2025
- Conditions
- Myofascial Pain Dysfunction Syndrome
- Keywords
- Trigger points injection, Myofascial Pain Dysfunction Syndrome (MPDS), Magnesium Sulfate, Surface Electromyography, Visual Analog Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 26 Nov 2026 (estimated)
- Study completion
- 26 Nov 2026 (estimated)
- First posted
- 5 Feb 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.
Two groups of patients diagnosed with Myofascial Pain Dysfunction Syndrome (MPDS) will be included in this study. One group will receive trigger point injections of lidocaine alone. The other group will receive trigger point injections of lidocaine combined with magnesium sulfate. The study aims to compare the effectiveness of both treatments in reducing pain and improving muscle function. Patients will be assessed using a pain scale (VAS) and surface electromyography (sEMG) to measure muscle activity.
Detailed description
This randomized clinical trial aims to evaluate whether adding magnesium sulfate to lidocaine in trigger point injections provides better pain relief and muscle relaxation in patients with Myofascial Pain Dysfunction Syndrome (MPDS) compared to lidocaine alone.
Participants diagnosed with MPDS will be randomly assigned into one of two groups:
Group 1 (Control Group): Trigger point injection of lidocaine 2% Group 2 (Intervention Group): Trigger point injection of lidocaine 2% combined with magnesium sulfate 10% Each participant will receive injections in the identified myofascial trigger points. Pain during injection and after injection will be assessed using the Visual Analog Scale (VAS). Muscle activity will be measured using surface electromyography (sEMG) at specific time points during rest and muscle contraction.
The study will compare the changes in pain scores and EMG readings between the two groups to determine whether magnesium sulfate enhances the analgesic and muscle-relaxing effects of lidocaine. The results of this study may help improve treatment strategies for MPDS and provide evidence for using magnesium sulfate as an adjuvant to lidocaine in trigger point injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups. Group 1 will receive lidocaine trigger point injections, while Group 2 will receive lidocaine combined with magnesium sulfate. Outcomes will be assessed at predefined follow-up visits using VAS and surface EMG.
| Arm | Type | Receives |
|---|---|---|
| Lidocaine injection | Active comparator | Drug: Lidocaine 2% (preservative-free, without vasoconstrictor)2%preservative-free without vasocostrictor injectable solution, 1.8 ml per injection point. |
| Injection of Magnesium sulfate with Lidocaine | Experimental | Drug: Lidocaine 2% + Magnesium Sulfate 10% (combination)10% injectable solution (100 mg/ml), from certified supplier. Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70 years.
- Clinical diagnosis of Myofascial Pain Dysfunction Syndrome (MPDS).
- Presence of active myofascial trigger points in accessible muscles (e.g., masseter, temporalis, upper trapezius).
- Pain duration ≥ 3 months.
- Pain intensity ≥ 4 on the Visual Analog Scale (VAS).
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to Lidocaine, Magnesium Sulfate, or related agents.
- Current use of anticoagulants or history of bleeding disorders.
- Systemic or local infection at or near the injection site.
- History of fibromyalgia, central pain syndromes, or cancer-related pain.
- Major psychiatric illnesses (e.g., schizophrenia, severe depression).
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 |
|---|---|---|
| Lidocaine 2% (preservative-free, without vasoconstrictor)Using 25-27G sterile disposable needle, intramuscular injection of 2%preservative-free solution of lidocaine without vasocostrictor, 1.8 ml at the most painful trigger points with "Fast-in, fast out" or "peppering" method and inject the solution slowly. | Drug | Lidocaine injection |
| Lidocaine 2% + Magnesium Sulfate 10% (combination)Using 25-27G sterile disposable needle, intramuscular injection of 2%preservative-free solution of lidocaine without vasocostrictor mixed with 10%magnesium sulphate , Approx. 3.8 ml per point (1.8 ml Lidocaine + 2 ml MgSO₄) at the most painful trigger points with "Fast-in, fast out" or "peppering" method and inject the solution slowly. | Drug | Injection of Magnesium sulfate with Lidocaine |
Primary outcome
Pain reduction.
Time frame: Baseline, 1week, 2 weeks post-injection.
Pain intensity will be assessed using the Visual Analogue Scale (VAS) ranging from 0 to 10 cm, where 0 indicates no pain and 10 indicates worst imaginable pain.
Muscle activity improvement.
Time frame: Baseline, 1 week, 2 weeks post-injection
Muscle activity will be assessed using surface electromyography (sEMG) by measuring Maximum Voluntary Contraction (MVC) in microvolts (µV). Higher values indicate improved muscle activity.
1 secondary outcome
Pain experienced during injection
Time frame: Immediately 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 5 Feb 2026.
- Background: PubMed 35339694Leitch J, Webb A, Pudwell J, Chamberlain S, Henry R, Nitsch R. Magnesium-Based Trigger Point Infiltrations Versus Local Anaesthetic Infiltrations in Chronic Pelvic Myofascial Pain: A Randomized, Double-Blind, Controlled Study. J Obstet Gynaecol Can. 2022 Aug;44(8):877-885. doi: 10.1016/j.jogc.2022.02.129. Epub 2022 Mar 24.
- Background: PubMed 36123724Refahee SM, Mahrous AI, Shabaan AA. Clinical efficacy of magnesium sulfate injection in the treatment of masseter muscle trigger points: a randomized clinical study. BMC Oral Health. 2022 Sep 19;22(1):408. doi: 10.1186/s12903-022-02452-3.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This is an academic thesis-based study, and the data contain sensitive personal and clinical information. Data access is restricted by institutional policies and ethical approval requirements. De-identified aggregate results will be reported in publications.
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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.
Khaled A Elhayes, PhD contact
Maii E Abdelazeem, Bsc principal investigator
Faculty of Oral & Dental Medicine, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine 2% (preservative-free, without vasoconstrictor) and Lidocaine 2% + Magnesium Sulfate 10% (combination) in people with Myofascial Pain Dysfunction Syndrome, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Feb 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 Egypt. 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.
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 Maii E Abdelazeem, BSc (+20 1013988933, Maii.emad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction. (time frame: Baseline, 1week, 2 weeks post-injection.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07390851, which also lists 2 linked publications.
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 5 Feb 2026.