PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
NCT ID: NCT04040309
Last Updated: 2020-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2019-05-10
2019-08-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
The second group of patients will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.
TREATMENT
NONE
Study Groups
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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.
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.
Lidocaine group
Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.
Lidocaine injection
1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.
Interventions
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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.
Lidocaine injection
1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Lithuanian University of Health Sciences
OTHER
Responsible Party
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Dovydas Šakalys
Principal Investigator
Principal Investigators
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Gintaras Januzis, PhD
Role: PRINCIPAL_INVESTIGATOR
Lithuanian University of Health Sciences
Locations
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LUHS Kaunas clinics Department of Maxillofacial surgery
Kaunas, , Lithuania
Countries
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Other Identifiers
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BE-10-10
Identifier Type: -
Identifier Source: org_study_id
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