PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

Phase 4

Completed

• Conditions: Myofascial Pain
• Interventions: Biological: PRGF injection; Drug: Lidocaine injection

• Registration Number: NCT04040309
• Lead Sponsor: Lithuanian University of Health Sciences

Brief Summary

The investigators set up a randomized controlled clinical trial to evaluate the effectiveness of plasma rich in growth factors (PRGF) injections into the masseter muscle trigger points for myofascial pain treatment. The investigators also seek to compare PRGF injections effectiveness with local anesthetic injections.

Dry needling and local anesthetics injections release trigger point by disrupting the membranes of a tout band. However, the injected substance itself does not affect the pathophysiological mechanism of the trigger point.

It is known that the platelets release growth factors who can enhance muscle regeneration processes and moreover reduce chronic pain.

The investigators raised a hypothesis that PRGF injections into the trigger points in masseter muscle can be an effective treatment method for the myofascial pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-10
• Study First Submitted: 2019-07-25
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-31
• Primary Completion: 2019-08-20
• Study Completion: 2019-08-25
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-18
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Adult patients.
• Diagnosed myofascial pain syndrome in one side of the masseter muscle (diagnosis is based on diagnostic criteria described by Travell and Simons: 1) palpable taut band, 2) spot tenderness in a taut band, 3) pain recognition.
• Patients have never had injections into their masseter muscle.

Exclusion Criteria

• Myofascial trigger points in other masticatory muscles.
• Head and neck region inflammations that causes pain.
• Temporomandibular joint pathology which causes pain.
• Trigeminal nerve neuralgia.
• Head and neck region oncological diseases.
• Myofascial trigger points in both sides of masseter muscles.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma rich in growth factors group	PRGF injection	Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle.
Lidocaine group	Lidocaine injection	Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.

Primary Outcome Measures

Name	Time	Method
Pain levels 2 weeks after the procedure: Visual analog scale	Patients pain levels will be measured 2 weeks after the procedure.	Patients will evaluate pain by using the Visual analog scale from 0 to 10. Where 0 means no pain and 10 means the worst possible pain
Pain levels 4 weeks after the procedure: Visual analog scale	Patients pain levels will be measured 4 weeks after the procedure.	Patients will evaluate pain by using the Visual analog scale from 0 to 10. Where 0 means no pain and 10 means the worst possible pain

Trial Locations

Locations (1)

LUHS Kaunas clinics Department of Maxillofacial surgery; 🇱🇹 Kaunas, Lithuania