Magnesium Sulphate Injection in Treatment of Myofascial Trigger Points
Study Details
Study Description
Brief Summary
This is a prospective, single- center, randomized (1:1) clinical trial comparing the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 4 |
Detailed Description
The proposal presents the magnesium sulphate (MgSO4) as a possible injection treatment for TrPs. The MgSO4 prevents the release of pre-synaptic acetylcholine from neuromuscular and sympathetic junctions that could explain the ability of the MgSO4 to relax the muscle and reduce pain Specific aim: evaluate the effectiveness of magnesium sulphate injections in treatment of myofascial trigger points in the masseter muscle versus the saline injection.
Hypothesis: the injection of masseter muscle trigger points with magnesium sulphate is more effective than saline injection in pain relief.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: group I each patient injected 0.5ml in each TrPs of saline by the same operator |
Drug: Saline
each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator
Other Names:
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Experimental: group II each patient injected 0.5ml in each TrPs of magnesium sulphate by the same operator |
Drug: Magnesium sulfate
each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator
Other Names:
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Outcome Measures
Primary Outcome Measures
- pain score [6 months postoperative]
pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.
Secondary Outcome Measures
- quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14) [six months postoperative]
OHIP-14 is used to measure patients' self-reported discomfort, disability, and functional limitation due to oral conditions with scores ranging from 0 to 56 (with 56 representing a subject answering ''very often'' to all 14 items)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Definite diagnosis of myofascial pain with a referral, based on the DC/TMD criteria
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the presence of one or more trigger points in the unilateral or bilateral masseter muscle
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no history of any invasive procedures in the related masseter muscle.
Exclusion Criteria:
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Factors that can cause pain in the orofacial region other than MTPs (decayed tooth, TMJ internal disorder).
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Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy
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pregnancy and lactation.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Faculty of Dentistry | Fayoum | Egypt | 63514 |
Sponsors and Collaborators
- Fayoum University
Investigators
- Principal Investigator: Alshaimaa Mohamed, phd, Fayoum University
Study Documents (Full-Text)
None provided.More Information
Publications
- Sakalys D, Rokicki JP, Januzis G, Kubilius R. Plasma rich in growth factors injection effectiveness for myofascial pain treatment in masticatory muscles. Randomised controlled trial. J Oral Rehabil. 2020 Jul;47(7):796-801. doi: 10.1111/joor.12973. Epub 2020 Apr 21.
- Yilmaz O, Sivrikaya EC, Taskesen F, Pirpir C, Ciftci S. Comparison of the Efficacy of Botulinum Toxin, Local Anesthesia, and Platelet-Rich Plasma Injections in Patients With Myofascial Trigger Points in the Masseter Muscle. J Oral Maxillofac Surg. 2021 Jan;79(1):88.e1-88.e9. doi: 10.1016/j.joms.2020.09.013. Epub 2020 Sep 14.
- Yousef AA, Al-deeb AE. A double-blinded randomised controlled study of the value of sequential intravenous and oral magnesium therapy in patients with chronic low back pain with a neuropathic component. Anaesthesia. 2013 Mar;68(3):260-6. doi: 10.1111/anae.12107. Epub 2012 Dec 17.
- Mg SO4 injections