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A Comparative Study on the Impact of Trigger Points Injection of Platelet Rich Plasma Versus Botulinum Toxin on the Relief of Jaw Muscles Myofascial Pain

NCT06814535 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-11

No results posted yet for this study

Summary

This study aims at comparing the effect of trigger points injection of platelet rich plasma and botulinum toxin a on the relief of jaw muscles Myofascial pain .

The 1st group includes 20 patients who are supposed to receive 5 units of botulinum toxin A per trigger point in masseter and/or temporalis muscles.

The 2nd group will receive ,5 ml of PRP per trigger point in masseter and/or temporalis muscles.

The 3rd group will receive .5 ml of physiologic saline per each trigger point in masseter and/or temporalis muscles.

The 1st follow up session will be after 1 week then 1 month then 3 months . The patients are advised to limit excessive Mouth opening, yawning or singing. And when pain episode , theta re advised to take only paracetamol as analgesic drug .

At the follow up sessions ، measuring the interincisal opening , pressure pain threshold using algometer , VAS to measure the intensity of pain , Likert scale , current pain intensity, worst pain intensity and the need to take analgesics in Numbers.

Then comparing the results of these groups to end in rejecting the null hypothesis which says there's an equivalence between the 3 types of injected solutions or accepting it .

Conditions

  • Patients with Jaw Muscles Myofascial Pain

Interventions

DRUG

Botulinum Toxin A / Botulinum Toxin A

Botulinum toxin type A

DRUG

Platelet rich plasma

Plasma that contains concentrated platelets

DRUG

Saline -- placebo comparator

Physiological saline .9 %

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06814535 on ClinicalTrials.gov