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Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial

Clinical Assessment of The Efficacy of Triamcinolone-Lidocaine Mix in Trigger Points Injection of Masseter Muscle: Double-blinded, Randomized Controlled Trial

Status
Not yet recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07445191
Enrollment
30
Registered
2026-03-03
Start date
2026-03-01
Completion date
2026-07-01
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

TMJ Pain

Keywords

masseter muscle

Brief summary

This study aims to clinically evaluate the efficacy of trigger points using active drug mix (Triamcinolone with lidocaine) on relief of myofascial pain of jaw muscle.

Interventions

DRUGSaline

Patients will take 1 ml of lidocaine 2%

DRUGTriamcinolone with lidocaine

Patients will take 1 ml of active drug mix (1/4 ml of Triamcinolone and 3/4 ml of lidocaine)

DRUGLidocaine

Patients will take 1 ml lidocaine 2%

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age more than or equal 18 years 2. Both sexes 3. Patients' willingness to follow instructions

Exclusion criteria

1. Patients who will be using any medications to reduce the pain and/or have any effect on the skeletal muscle 2. Clinical conditions such as pregnancy 3. Medical problems that may interfere with the procedures such as bleeding disorders 4. Cognitive impairment or exhibited inadequate cooperation 5. Patients will be receiving physical therapy or wearing occlusal splint in the same period of the research

Design outcomes

Primary

MeasureTime frameDescription
current pain intensity1 week , 1 month , 3 months after treatment• Patients' subjective pain experience. Each patient will be asked to rate his or her current and worst pain intensity on visual analogue scale (VAS) of 0-10 with zero being no pain and ten corresponds to the worst pain that the patient ever had

Secondary

MeasureTime frameDescription
maximum mouth opening1 week , 1 month , 3 months after treatment* Maximum mouth opening (MMO). Assessment of MMO will be performed by measuring the distance in mm between the incisal edges of the upper and lower central incisors using a ruler. * The postoperative demand for analgesics will be evaluated by recording the number of the analgesic's intake. * Patient satisfaction. * Pressure pain threshold (PPT). Data will be collected preoperatively, pain will be measured immediately after the treatment, as well as one week, one month, and 3 months after the end of the treatment sessions
post operative demands for analgesics1 week , 1 month , 3 months after treatmentmeasuring unit number
patient satisfaction1 week , 1 month , 3 months after treatmentmeasured by likert scale
pressure pain threshold (PPT)1 week , 1 month , 3 months after treatmentmeasuresd by algometer

Contacts

CONTACTAmmar Ali Mudhsh Al-Hawbani Ammar Ali Mudhsh Al-Hawbani, bachelor's degree
prof.hamidarefaee@gmail.com0103052078
CONTACTHamida Refai Hasanien Hasanien professor, phd
01013052078
STUDY_DIRECTORHamida Refai Hasanien Hasanien Hamida Refai Hasanien, phd

cair university

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026