Myofacial Pain
Conditions
Brief summary
Patients with orofacial pain lasting at least 3 months. The patients will be randomly assigned to one of the two groups according to the treatment method: group I (intraoral injection) and group II (transcutaneous injection) where each patient injected Botox at each trigger point according to the treatment group by the same operator. Patients will be examined by a blinded investigator at pre- and post-injections at the following intervals: during diagnosis, 1 week, 4, and 6 weeks post-injection. The patients will be assessed using a pain score measured on a 10-point visual analog scale (VAS). The secondary outcome assessed will be measuring the quality of life in an Oral Health Impact Profile questionnaire (OHIP-14).
Interventions
DRUGintraoral trigger point injection by botox
intraoral injection of trigger point of masseter muscle by botulinum toxin
DRUGtranscutaneous trigger point injection by botox
transcutaneous injection of masseter muscle by botulinum toxin
Sponsors
Fayoum University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Definite diagnosis of myofascial pain with a referral * 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 trigger points (decayed tooth, temporomandibular joint 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 weeks post injection | The participated patients will be assessed using 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 |
|---|---|---|
| (OHIP-14) scale | 6 weeks | 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