NCT03323567

A Comparison of Collagen, Lidocaine and Saline, in Trigger Points in Masseter Muscle.

A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Medical University of Silesia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An intramusclular injection of three solutions were performed( collagen, lidocaine, saline) in musculoskeletal trigger points, in patients suffering from temporomandibular disorders(TMD). Best results were observed in collagen group: reduction of 59,2% sEMG activity of masseter muscles and 53,75% reduction of pain intensity in VAS scale.

Detailed description

Collagen is an important component, building myocytes and extracellular matrix of skeletal muscles. The novel treatment option for trigger point therapy and muscle regeneration in TMD patients are intramuscular collagen injections. The aim of the study was to evaluate the efficacy of intramuscular injections of Collagen MD Muscle(Guna) 2 ml, 2 ml of Lidocainum 2% without vasoconstrictor and 2 ml of Saline (0,9 % NaCl). 43 patients were enrolled to the study (17 male and 26 female, 40 +/- 3,8 years old). The masseter muscle activity was measured with sEMG Neurobit Optima 4 (Neurobit System). Visual Analogue Scale was used to determine pain intensity changes between follow-up visits in each group. Trigger points were localized with palpation of masseter muscle. Electromyographic activity of masseter muscle was measured before injections on each visit: 0, 7,14 days. In our analysis sEMG masseter muscle activity was significantly decreased: in collagen group 59,2%, in lidocainum group 39,3% and in saline group14%. Pain intensity reduction in VAS scale was 53,75% in collagen group, in lidocainum group 25% and in saline group 20,1%.

Conditions

• Temporomandibular Disorder

Interventions

Type	Name	Description
DRUG	MD Muscle GUNA collagen	intramusclular injections of MD Muscle collagen
DRUG	Lidocaine 2% Injectable Solution	intramuscular Lidocaine 2% injection
DRUG	Saline Solution, Hypertonic	intramuscular Saline injection

Timeline

• Start date: 2016-01-10
• Primary completion: 2017-10-04
• Completion: 2017-10-12
• First posted: 2017-10-27
• Last updated: 2018-01-04

Locations

1 site across 1 country: Poland