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PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04040309
Enrollment
50
Registered
2019-07-31
Start date
2019-05-10
Completion date
2019-08-25
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain

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.

Interventions

BIOLOGICALPRGF 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.

1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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, 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.

Design outcomes

Primary

MeasureTime frameDescription
Pain levels 2 weeks after the procedure: Visual analog scalePatients 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 scalePatients 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

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026