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

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

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 .

Study Overview

• Status: Active, not recruiting
• Conditions: Patients with Jaw Muscles Myofascial Pain
• Intervention / Treatment: Drug: Botulinum Toxin A / Botulinum Toxin A; Drug: Platelet rich plasma; Drug: Saline -- placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt
    • Faculty of Dentistry Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patient with myofascial trigger points in masseter or temporalis previously ----*identified by manual palpation.

  • 18 years or More "Willingness to follow instructions.

Exclusion Criteria:

• therapeutic intervention for myofascial pain in the last view months such as taking medications for pain control or wearing an occlusal splint.

  • Clinical conditions as pregnancy
  • Medical problems that will interfere with the procedure as bleeding disorders.
  • Cognitive impairment or present inadequate cooperation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Botulinum toxin A; 20 Patients with Myofascial pain will be injected by 5 units botulinum toxin A per trigger point in masseter and/or temporalis	Drug: Botulinum Toxin A / Botulinum Toxin A; Botulinum toxin type A
Active Comparator: Platelet rich plasma; 20 patients with Myofascial pain will be injected by .5 ml PRP solution per trigger point in masseter and/or temporalis	Drug: Platelet rich plasma; Plasma that contains concentrated platelets
Placebo Comparator: Physiologic saline; 20 patients with Myofascial pain will be injected by.5 ml physiologic saline per each trigger point	Drug: Saline -- placebo comparator; Physiological saline .9 %

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure pain threshold	The amount of force per kilogram needed to induce pain in patients with myofascial pain at the trigger point.. Will be measured using the algometer which presses on the trigger point to induce pain by force measured in kilograms/cm2 If the reading increased among the treatment visits , this means better outcome and decreased pain intensity with effectiveness of the treatment	3 months
Current pain intensity	The amount of pain on VAS at the time of examination from 0-10 With 0 no pain which increases to reach 10 ( the highest pain intensity).. Decrease in pain intensity means better outcome	3 months
Worst pain intensity	The worst pain the patient had suffered from on the previous duration. Using visual analogue scale from (0-10) with 0 least pain and 10 worst pain . Decrease in pain intensity means better outcome	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter incisal opening	The measurement in millimeters of the distance between the incisal edge of the upper incisor and the lower incisor Using calibers to measure the effect of myofascial pain on decreasing muscle spasm and the effectiveness of the treatment by time. Increased degree of mouth opening meaning the muscles had relaxed and trigger points released	3 months
Patient satisfaction	Will be measured by Likert scale by faces to indicate whether the treatment was satisfactory to the patient or not and to which degree .it affected their quality of life	3 months
The need for analgesics	The patient will count how many Paracetamol tabs he took at the time from the last visit till now. With decreased amount of analgesics taken between the visits means better outcome	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: January 26, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 8, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Neurotransmitter Agents; Membrane Transport Modulators; Cholinergic Agents; Neuromuscular Agents; Acetylcholine Release Inhibitors; Botulinum Toxins, Type A; abobotulinumtoxinA; Botulinum Toxins
• Other Study ID Numbers: CEBD_CU_9122023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No