PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
Primary Purpose
Myofascial Pain
Status
Completed
Phase
Phase 4
Locations
Lithuania
Study Type
Interventional
Intervention
PRGF injection
Lidocaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pain
Eligibility Criteria
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.
Sites / Locations
- LUHS Kaunas clinics Department of Maxillofacial surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Plasma rich in growth factors group
Lidocaine group
Arm Description
Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle.
Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04040309
First Posted
July 25, 2019
Last Updated
February 18, 2020
Sponsor
Lithuanian University of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04040309
Brief Title
PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
Official Title
Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2019 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
August 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plasma rich in growth factors group
Arm Type
Experimental
Arm Description
Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle.
Arm Title
Lidocaine group
Arm Type
Active Comparator
Arm Description
Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle.
Intervention Type
Biological
Intervention Name(s)
PRGF injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine injection
Intervention Description
1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.
Primary Outcome Measure Information:
Title
Pain levels 2 weeks after the procedure: Visual analog scale
Description
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
Time Frame
Patients pain levels will be measured 2 weeks after the procedure.
Title
Pain levels 4 weeks after the procedure: Visual analog scale
Description
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
Time Frame
Patients pain levels will be measured 4 weeks after the procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gintaras Januzis, PhD
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
LUHS Kaunas clinics Department of Maxillofacial surgery
City
Kaunas
ZIP/Postal Code
LT-50161
Country
Lithuania
12. IPD Sharing Statement
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PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
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