PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

• Sponsor: Lithuanian University of Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT04040309
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.5
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain	Biological: PRGF injection; Drug: Lidocaine injection	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial
• Actual Study Start Date: May 10, 2019
• Actual Primary Completion Date: Aug 20, 2019
• Actual Study Completion Date: Aug 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Plasma rich in growth factors group Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle.	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.
Active Comparator: Lidocaine group Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial 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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	LUHS Kaunas clinics Department of Maxillofacial surgery	Kaunas		Lithuania	LT-50161

Sponsors and Collaborators

• Lithuanian University of Health Sciences

Investigators

• Principal Investigator: Gintaras Januzis, PhD, Lithuanian University of Health Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dovydas Šakalys, Principal Investigator, Lithuanian University of Health Sciences
• ClinicalTrials.gov Identifier: NCT04040309
• Other Study ID Numbers: BE-10-10
• First Posted: Jul 31, 2019
• Last Update Posted: Feb 19, 2020
• Last Verified: Feb 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Myofascial Pain Syndromes; Lidocaine

Study Results

No Results Posted as of Feb 19, 2020