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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: TMJ Pain
• Intervention / Treatment: Drug: Saline; Drug: Triamcinolone with lidocaine; Drug: Lidocaine

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Ammar Ali Mudhsh Al-Hawbani Ammar Ali Mudhsh Al-Hawbani, bachelor's degree; Phone Number: 0103052078; Email: prof.hamidarefaee@gmail.com
• Study Contact Backup: Name: Hamida Refai Hasanien Hasanien professor, phd; Phone Number: 01013052078

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine	Drug: Lidocaine; Patients will take 1 ml lidocaine 2%
Active Comparator: Saline	Drug: Saline; Patients will take 1 ml of lidocaine 2%
Experimental: Triamcinolone with lidocaine	Drug: Triamcinolone with lidocaine; Patients will take 1 ml of active drug mix (1/4 ml of Triamcinolone and 3/4 ml of lidocaine)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
current pain intensity	• 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	1 week , 1 month , 3 months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum mouth opening	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	1 week , 1 month , 3 months after treatment
post operative demands for analgesics	measuring unit number	1 week , 1 month , 3 months after treatment
patient satisfaction	measured by likert scale	1 week , 1 month , 3 months after treatment
pressure pain threshold (PPT)	measuresd by algometer	1 week , 1 month , 3 months after treatment

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Hamida Refai Hasanien Hasanien Hamida Refai Hasanien, phd, cair university

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: February 28, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: masseter muscle
• Additional Relevant MeSH Terms: Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Inorganic Chemicals; Chlorine Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Sodium Compounds; Chlorides; Hydrochloric Acid; Lidocaine; Triamcinolone; Sodium Chloride
• Other Study ID Numbers: injection of masseter muscle

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No