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PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

L

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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