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Completed

NCT Number: NCT03323567

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department of TMD and Orthodontics Silesian Medical University

Zabrze, 41-800, Poland

About this study

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%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral

Exclusion criteria

  • younger than 18years old, active orthodonctic treatment,neurological treatment, post radiotherapy, after head trauma within 2 years, patients with unsupported occlusal contacts, addicted to analgesic drugs, with the fear of needle

Treatment and study plan

MD Muscle GUNA collagen

Drug

intramusclular injections of MD Muscle collagen

Other names: intramuscular MD Muscle collagen injection

Lidocaine 2% Injectable Solution

Drug

intramuscular Lidocaine 2% injection

Other names: intramuscular Lidocaine 2% injection

Saline Solution, Hypertonic

Drug

intramuscular Saline injection

Other names: intramuscular Saline injection

Primary outcomes

  1. sEMG reduction of masseter muscle in TMD patients

    Time frame: 14 days

    reduction of electromyograpic activity of masseter muscle

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 27, 2017
Registry last updated
Jan 4, 2018

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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