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

ConditionTMJ Pain
Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age more than or equal 18 years

Both sexes

Patients' willingness to follow instructions

Disqualifiers

Patients who will be using any medications to reduce the pain and/or have any effect on the skeletal muscle

Clinical conditions such as pregnancy

Medical problems that may interfere with the procedures such as bleeding disorders

Cognitive impairment or exhibited inadequate cooperation

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline

    Drug

    Patients will take 1 ml of lidocaine 2%

  • Triamcinolone with lidocaine

    Drug

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

  • Lidocaine

    Drug

    Patients will take 1 ml lidocaine 2%

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: SalineActive comparator 1 intervention
Group B: Triamcinolone with lidocaineExperimental treatment 1 intervention
Group C: LidocaineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 week , 1 month , 3 months after treatment

Secondary outcomes

1

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

Time frame
1 week , 1 month , 3 months after treatment
2

post operative demands for analgesics

measuring unit number

Time frame
1 week , 1 month , 3 months after treatment
3

patient satisfaction

measured by likert scale

Time frame
1 week , 1 month , 3 months after treatment
4

pressure pain threshold (PPT)

measuresd by algometer

Time frame
1 week , 1 month , 3 months after treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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