PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

Myofascial Pain Clinical Trial

Official title:

Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04040309
• Other study ID #: BE-10-10
• Status: Completed
• Phase: Phase 4
• Start date: May 10, 2019
• Est. completion date: August 25, 2019

Study information

• Verified date: February 2020
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 25, 2019
• Est. primary completion date: August 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myofascial Pain
• Myofascial Pain Syndromes

Intervention

Biological:
• PRGF injection
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.

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

Locations

Country	Name	City	State
Lithuania	LUHS Kaunas clinics Department of Maxillofacial surgery	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.