Trigger Point Pain, Myofascial
Conditions
Keywords
trigger point, masseter muscle, myofascial pain, magnesium sulphate
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.
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.
Interventions
DRUGMagnesium sulfate
each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator
DRUGSaline
each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Definite diagnosis of myofascial pain with a referral, based on the DC/TMD criteria * the presence of one or more trigger points in the unilateral or bilateral masseter muscle * no history of any invasive procedures in the related masseter muscle.
Exclusion criteria
* Factors that can cause pain in the orofacial region other than MTPs (decayed tooth, TMJ internal disorder). * Any systemic disease that possibly affects the masticatory system such as rheumatoid arthritis and epilepsy * pregnancy and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Egypt
Outcome results
None listed