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NCT Number: NCT04040309

PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles

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.

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Key information

Conditions

Myofascial Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LUHS Kaunas clinics Department of Maxillofacial surgery

Kaunas, LT-50161, Lithuania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PRGF injection

Biological

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

Drug

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2019
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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