A Phase 4 interventional study of Magnesium sulfate and Saline in Trigger Point Pain, Myofascial, sponsored by Fayoum University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-12-07.
Sponsored by Fayoum University · Phase 4, Interventional, and Treatment
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.
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.
1,136 studies on the registry are indexed under Myofascial Pain Syndromes; 137 are open to participants now.
This study's enrollment of 180 is above the median of 60 across 931 interventional studies indexed under Myofascial Pain Syndromes.
Browse Myofascial Pain Syndromes studies →Fayoum University is the lead sponsor of 144 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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
Also known as: Study
each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator
Also known as: Control
pain score
pain score measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever.
Time frame: 6 months postoperative
quality-of-life in an Oral Health Impact Profile questionnaire (OHIP-14)
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)
Time frame: six months postoperative
Plan to share: No
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Fayoum University