Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04040309
Other study ID # BE-10-10
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 10, 2019
Est. completion date August 25, 2019

Study information

Verified date February 2020
Source Lithuanian University of Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date August 25, 2019
Est. primary completion date August 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Lithuania LUHS Kaunas clinics Department of Maxillofacial surgery Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Patients pain levels will be measured 2 weeks after the procedure.
Primary 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 Patients pain levels will be measured 4 weeks after the procedure.
See also
  Status Clinical Trial Phase
Completed NCT04157426 - Percutaneous Electrolysis Versus Dry Needling in Levator Scapulae N/A
Enrolling by invitation NCT06029413 - Myo vs. Myofascial Injection for Myofascial Trigger Points N/A
Not yet recruiting NCT05637047 - Pulsed Radiofrequency vs Dry Needling in Myofascial Pain N/A
Completed NCT04057781 - Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus. N/A
Recruiting NCT06036524 - Multi-modal Imaging of Myofascial Pain N/A
Completed NCT04897581 - BBTI vs PSR in Musculoskeletal Orofacial Pain Adults N/A
Completed NCT03398486 - The Effectiveness of Kinesiotaping and Inactivation of Trigger Points in Chronic Myofascial Pain of TMD N/A
Recruiting NCT05928884 - Ultrasound Imaging for Myofascial Pain
Completed NCT04790071 - Dry Needling Treatment in Hemiplegic Shoulder Pain N/A
Completed NCT03704311 - Evaluation of Mitochondrial Function in Myofascial Trigger Points Cohort Pilot Study Using High-resolution Respirometry N/A
Completed NCT05365932 - Evaluation of an Intra Auricular Device as a Treatment for Painful Temporo-Mandibular Disorders N/A
Completed NCT04628286 - Myofascial Induction Effects on Stabilometry Versus Sham Laser N/A
Completed NCT04628299 - Effects of the Myofascial Induction Technique Versus a Control Laser N/A
Completed NCT04884152 - Telerehabilitation in Individuals Temporomandibular Dysfunction With Bruxism N/A
Completed NCT01850420 - A Study of IMC-1 In Patients With Fibromyalgia Phase 2
Terminated NCT03028012 - TPI Medication Comparison - Ketorolac, Lidocaine, or Dexamethasone Phase 4
Completed NCT04929171 - Myofascial Pain and Central Sensitization
Completed NCT03651141 - The Effects of Soft Tissue Therapy and Exercise on Hamstring Tightness N/A
Recruiting NCT03885791 - Randomized Controlled Trial of Vaginal Cryotherapy for Pelvic Floor Myofascial Pain N/A
Completed NCT02389140 - Blood Flow Within Active Myofascial Trigger Points Following Massage N/A