PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

Lithuanian University of Health Sciences

Status and phase: Completed; Phase 4

Conditions: Myofascial Pain

Treatments: Drug: Lidocaine injection; Biological: PRGF injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04040309

BE-10-10

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Plasma rich in growth factors group

Experimental group

Description:

Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle.

Treatment:

Biological: PRGF injection

Lidocaine group

Active Comparator group

Description:

Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.

Treatment:

Drug: Lidocaine injection