PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
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|ClinicalTrials.gov Identifier: NCT04040309|
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : February 19, 2020
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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)|
|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|
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.
- 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
- 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
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
|LUHS Kaunas clinics Department of Maxillofacial surgery|
|Kaunas, Lithuania, LT-50161|
|Principal Investigator:||Gintaras Januzis, PhD||Lithuanian University of Health Sciences|