PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

NCT04040309 | Completed Phase 4

• 1 other identifier: BE-10-10
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain

Outcome Measures

Primary Outcomes (2)

• Pain levels 2 weeks after the procedure: Visual analog scale

  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

  Patients pain levels will be measured 2 weeks after the procedure.

• Pain levels 4 weeks after the procedure: Visual analog scale

  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

  Patients pain levels will be measured 4 weeks after the procedure.

Study Arms (2)

Plasma rich in growth factors group

EXPERIMENTAL

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

Biological: PRGF injection

Lidocaine group

ACTIVE COMPARATOR

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

Drug: Lidocaine injection

Interventions

PRGF injection BIOLOGICAL

Plasma rich in growth factors will be prepared following the protocol described by E. Anitua. 9 ml of patients venous blood will be taken into one tube with 3,8% sodium citrate used as an anticoagulant. The blood then will be centrifuged (PRGF Centrifuge System, Biotechnology Institute, Vitoria, Spain) at room temperature for 8 min at 1800 rpm. After centrifugation 1 ml of 2nd plasma fraction will be collected by using a pipet. To activate plasma 10% calcium chloride will be used immediately before injecting plasma into the trigger point in the masseter muscle.

Plasma rich in growth factors group

Lidocaine injection DRUG

1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.

Lidocaine group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

LUHS Kaunas clinics Department of Maxillofacial surgery

Kaunas, LT-50161, Lithuania

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Gintaras Januzis, PhD

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The first group of patients will receive 1 ml PRGF 2nd fraction injections into the myofascial trigger point in the masseter muscle. The second group of patients will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 31, 2019
• Study Start: May 10, 2019
• Primary Completion: August 20, 2019
• Study Completion: August 25, 2019
• Last Updated: February 19, 2020

Record last verified: 2020-02

Locations

LI (1)