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 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: CEBD_CU_9122023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Inter incisal opening

  3 months

• Patient satisfaction

  3 months

• The need for analgesics

  3 months

Study Arms (3)

Botulinum toxin A

ACTIVE COMPARATOR

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

Platelet rich plasma

ACTIVE COMPARATOR

20 patients with Myofascial pain will be injected by .5 ml PRP solution per trigger point in masseter and/or temporalis

Physiologic saline

PLACEBO COMPARATOR

20 patients with Myofascial pain will be injected by.5 ml physiologic saline per each trigger point

Interventions

Botulinum Toxin A / Botulinum Toxin A DRUG

Botulinum toxin type A

Botulinum toxin A

Platelet rich plasma DRUG

Plasma that contains concentrated platelets

Saline -- placebo comparator DRUG

Physiological saline .9 %

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patient with myofascial trigger points in masseter or temporalis previously ----\*identified by manual palpation.
• years or More "Willingness to follow instructions.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo University

Giza, Egypt

Location

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 26, 2025
• First Posted: February 7, 2025
• Study Start: June 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-02

Locations

EG (1)