Myofascial PainPhase 4NCT04040309
PRGF Effectiveness for Myofascial Pain Treatment in Masticatory Muscles
A Phase 4 study testing PRGF injection and Lidocaine injection in people with Myofascial Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myofascial Pain
- What is being tested?
- PRGF injection and Lidocaine injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteLithuania
- Study dates
- 10 May 2019to 25 Aug 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
LUHS Kaunas clinics Department of Maxillofacial surgery
Kaunas, LT-50161
About this study
Official title: Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial
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.
Read more
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.
- Conditions
- Myofascial Pain
- Being tested
- PRGF injection, Lidocaine injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRGF injectionBiological
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 injectionDrug
1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.
| Study group | Role | What they receive |
|---|---|---|
| Plasma rich in growth factors group | Experimental | Group of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle. Receives: Biological: PRGF injection |
| Lidocaine group | Active comparator | Group of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle. Receives: Drug: Lidocaine injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Patients pain levels will be measured 2 weeks after the procedure.
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
Measured: Patients pain levels will be measured 4 weeks after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start10 May 2019
- Primary completion20 Aug 2019
- Study completion25 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dovydas Šakalys, Lithuanian University of Health Sciences
- Investigators
- Gintaras Januzis, PhD, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040309
- Sponsor's protocol ID
- BE-10-10
- Status last verified
- Feb 2020
- First submitted
- 25 Jul 2019
- Last updated
- 19 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Rich in Growth Factors Effectiveness for Myofascial Pain Treatment in Masticatory Muscles: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04040309
- Acronym / sponsor ID
- BE-10-10
- Conditions
- Myofascial Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 10 May 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 25 Aug 2019 (actual)
- First posted
- 31 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Plasma rich in growth factors group | Experimental | Biological: PRGF injectionGroup of patients who will receive 1 ml of PRGF 2nd fractions injections into their trigger points in the masseter muscle. |
| Lidocaine group | Active comparator | Drug: Lidocaine injectionGroup of patients who will receive 1 ml 2% Lidocaine injections into the myofascial trigger point in the masseter muscle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRGF injectionPlasma 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. | Biological | Plasma rich in growth factors group |
| Lidocaine injection1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle. | Drug | Lidocaine group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gintaras Januzis, PhD principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRGF injection and Lidocaine injection in people with Myofascial Pain, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain levels 2 weeks after the procedure: Visual analog scale (time frame: Patients pain levels will be measured 2 weeks after the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.