Myofascial Pain Dysfunction SyndromePhase 2NCT06595017
Lidocaine Versus Magnesium Sulphate in Management of Myofascial Pain Dysfunction Syndrome
A Phase 2 study testing Magnesium sulphate, Lidocaine (drug) and Saline in people with Myofascial Pain Dysfunction Syndrome, run by Misr University for Science and Technology.
Trial summary
The goal of this clinical trial is to investigate the effectiveness of Magnesium Sulphate in the management of myofascial pain dysfunction syndrome in comparison to Lidocaine and Saline. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Myofascial Pain Dysfunction Syndrome
- What is being tested?
- Magnesium sulphate, Lidocaine (drug) and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 30 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age Limitations: Participants must be between 18 and 55 years old.
- Chronic Pain Diagnosis: Individuals must have a diagnosis of chronic myofascial pain dysfunction syndrome (MPDS) affecting the face muscles, neck, shoulder, or upper back for a duration exceeding three months.
- Trigger Point Recognition: Patients must show awareness of their pain when pressure is applied to identified myofascial trigger points, in accordance with established diagnostic guidelines.
- Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.
Who cannot join
- Previous Treatments: A history of receiving dry needling or pulsed radiofrequency therapy, or currently participating in other pain management treatments.
- Recent Injury or Surgery: Any recent trauma, surgical procedures, or infections in the affected area within the past six months.
- Medication Interference: Current or recent use of moderate to strong analgesics (e.g., tramadol, morphine) that could influence pain assessment.
- Severe Health Conditions: Individuals with significant systemic illnesses (e.g., severe liver or kidney disease), blood clotting disorders, rheumatoid arthritis or epilepsy.
- Mental Health: Presence of current psychiatric disorders, cognitive impairments, or inability to comply with the study protocol.
Trial locations and contacts
No sites are listed yet.
Maha Majied Demonstrator in Oral and Maxillofacial Surgery Department contact
About this study
Official title: Evaluation of the Effect of Magnesium Sulfate Injection in Comparison to Lidocaine for Management of Myofascial Pain Dysfunction Syndrome: a Randomized Controlled Clinical Trial
The goal of this clinical trial is to investigate the effectiveness of Magnesium Sulphate in the management of myofascial pain dysfunction syndrome in comparison to Lidocaine and Saline.
A total of 75 patients suffering from myofascial pain dysfunction syndrome will be assigned into one of three groups, each with 25 patients.
Group A: (Saline) includes patients enrolled for Saline injection into the trigger points. Group B: (Magnesium Sulphate) includes patients enrolled for Magnesium Sulphate injection into the trigger points. Group C: (Lidocaine) includes patients who will be enrolled for Lidocaine injection into the trigger points The primary outcome that will be investigated is (pain with a visual analogue score), and secondary outcomes will be (maximum mouth opening between edges of upper and lower incisors with millimeters, electrical activity with Electromyography, and quality of life assessed using the Oral Health Impact Profile questionnaire) The outcomes will be assessed pre-injection, 1month after injection, 3months after injection, and 6 months after injection
- Conditions
- Myofascial Pain Dysfunction Syndrome
- Being tested
- Magnesium sulphate, Lidocaine (drug), Saline
- Keywords
- Myofascial pain dysfunction syndrome, Magnesium Sulphate, Lidocaine, Pain, Electromyography
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulphateDrug
After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of magnesium sulphate
Lidocaine (drug)Drug
After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Lidocaine
SalineDrug
After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Saline
| Study group | Role | What they receive |
|---|---|---|
| Saline arm | Placebo comparator | After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of saline Receives: Drug: Saline |
| Lidocaine arm | Active comparator | After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of lidocaine Receives: Drug: Lidocaine (drug) |
| Magnesium Sulphate arm | Active comparator | Not described Receives: Drug: Magnesium sulphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain intensity was assessed using a 10-cm line visual analog scale (VAS) that represents a continuum between "no pain" and "worst pain." with 0 cm representing no pain, and 10 cm representing the worst pain imaginable.
Measured: At interval pre-injection and 1, 3, and 6 months after injection.
Secondary outcomes (3)
The maximum mouth opening
The maximum mouth opening (MMO) was evaluated by measuring the interincisal distance between the upper and lower central incisors.
Measured: At interval pre-injection and 1, 3, and 6 months after injection.
Electrical activity
Measured using electromyography, EMG can provide valuable insights into altered muscle activity patterns and help in the diagnosis and management of myofascial pain dysfunction syndrome through readings.
Measured: At interval pre-injection and 1, 3, and 6 months after injection.
Quality of life
evaluated using the Oral Health Impact Profile questionnaire (OHIP-14), which consists of 14 items categorized into seven domains of oral health. Participants were instructed to score each item on a scale from 0 to 4, where 0 indicates never, 1 represents hardly ever, 2 signifies occasionally, 3 denotes fairly often, and 4 corresponds to very often. The total score was computed by summing the responses to all 14 items, with higher scores reflecting a greater negative impact on oral health-related quality of life
Measured: At interval pre-injection and 1, 3, and 6 months after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Dysfunction 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Abd ALMajied Mahmoud Mohamed, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595017
- Sponsor's protocol ID
- 1
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Magnesium Sulfate Injection in Comparison to Lidocaine for Management of Myofascial Pain Dysfunction Syndrome: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06595017
- Acronym / sponsor ID
- 1
- Conditions
- Myofascial Pain Dysfunction Syndrome
- Keywords
- Myofascial pain dysfunction syndrome, Magnesium Sulphate, Lidocaine, Pain, Electromyography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 19 Sep 2024 (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 goal of this clinical trial is to investigate the effectiveness of Magnesium Sulphate in the management of myofascial pain dysfunction syndrome in comparison to Lidocaine and Saline.
A total of 75 patients suffering from myofascial pain dysfunction syndrome will be assigned into one of three groups, each with 25 patients.
Group A: (Saline) includes patients enrolled for Saline injection into the trigger points. Group B: (Magnesium Sulphate) includes patients enrolled for Magnesium Sulphate injection into the trigger points. Group C: (Lidocaine) includes patients who will be enrolled for Lidocaine injection into the trigger points The primary outcome that will be investigated is (pain with a visual analogue score), and secondary outcomes will be (maximum mouth opening between edges of upper and lower incisors with millimeters, electrical activity with Electromyography, and quality of life assessed using the Oral Health Impact Profile questionnaire) The outcomes will be assessed pre-injection, 1month after injection, 3months after injection, and 6 months after injection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Saline arm | Placebo comparator | Drug: SalineAfter localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of saline |
| Lidocaine arm | Active comparator | Drug: Lidocaine (drug)After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of lidocaine |
| Magnesium Sulphate arm | Active comparator | Drug: Magnesium sulphate |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age Limitations: Participants must be between 18 and 55 years old.
- Chronic Pain Diagnosis: Individuals must have a diagnosis of chronic myofascial pain dysfunction syndrome (MPDS) affecting the face muscles, neck, shoulder, or upper back for a duration exceeding three months.
- Trigger Point Recognition: Patients must show awareness of their pain when pressure is applied to identified myofascial trigger points, in accordance with established diagnostic guidelines.
- Consent to Participate: Willingness to provide informed consent and engage in all aspects of the study.
Key exclusion criteria (5 listed)
- Previous Treatments: A history of receiving dry needling or pulsed radiofrequency therapy, or currently participating in other pain management treatments.
- Recent Injury or Surgery: Any recent trauma, surgical procedures, or infections in the affected area within the past six months.
- Medication Interference: Current or recent use of moderate to strong analgesics (e.g., tramadol, morphine) that could influence pain assessment.
- Severe Health Conditions: Individuals with significant systemic illnesses (e.g., severe liver or kidney disease), blood clotting disorders, rheumatoid arthritis or epilepsy.
- Mental Health: Presence of current psychiatric disorders, cognitive impairments, or inability to comply with the study protocol.
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 |
|---|---|---|
| Magnesium sulphateAfter localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger points at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of magnesium sulphate | Drug | Magnesium Sulphate arm |
| Lidocaine (drug)After localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Lidocaine | Drug | Lidocaine arm |
| SalineAfter localization of the trigger points, the skin was disinfected with alcohol, the tight muscle band was grabbed between two fingers, and a 30-gage 3/4-inch needle was introduced 1-2 cm away from the trigger point at a 30º angle to the skin. Negative aspiration was performed and each trigger point was injected with 2 ml of Saline | Drug | Saline arm |
Primary outcome
Pain score
Time frame: At interval pre-injection and 1, 3, and 6 months after injection.
Pain intensity was assessed using a 10-cm line visual analog scale (VAS) that represents a continuum between "no pain" and "worst pain." with 0 cm representing no pain, and 10 cm representing the worst pain imaginable.
3 secondary outcomes
The maximum mouth opening
Time frame: At interval pre-injection and 1, 3, and 6 months after injection.
Electrical activity
Time frame: At interval pre-injection and 1, 3, and 6 months after injection.
Quality of life
Time frame: At interval pre-injection and 1, 3, and 6 months after injection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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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. This study is not recruiting at the moment.
Maha Majied Demonstrator in Oral and Maxillofacial Surgery Department contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magnesium sulphate, Lidocaine (drug) and Saline in people with Myofascial Pain Dysfunction Syndrome, run by Misr University for Science and Technology.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maha Majied Demonstrator in Oral and Maxillofacial Surgery Department (00201024127018, maha.abdalmajied@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: At interval pre-injection and 1, 3, and 6 months after injection.). 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 19 Sep 2024.