PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

Study Overview
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Brief Summary
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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.

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

Conditions
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Myofascial Pain

Intervention / Treatment
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* Biological: PRGF injection
* Drug: Lidocaine injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plasma rich in growth factors group<br>Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle. | Biological: PRGF injection<br>* 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.<br>|
| Active Comparator: Lidocaine group<br>Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle. | Drug: Lidocaine injection<br>* 1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |