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PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04040309
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Dovydas Šakalys, Lithuanian University of Health Sciences

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

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Study Type : Interventional  (Clinical Trial)
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.

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 : August 20, 2019
Actual Study Completion Date : August 25, 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Pain levels 2 weeks after the procedure: Visual analog scale [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04040309


Locations
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Lithuania
LUHS Kaunas clinics Department of Maxillofacial surgery
Kaunas, Lithuania, LT-50161
Sponsors and Collaborators
Lithuanian University of Health Sciences
Investigators
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Principal Investigator: Gintaras Januzis, PhD Lithuanian University of Health Sciences
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Responsible Party: Dovydas Šakalys, Principal Investigator, Lithuanian University of Health Sciences
ClinicalTrials.gov Identifier: NCT04040309    
Other Study ID Numbers: BE-10-10
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020

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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:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action