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

Study Overview
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Brief Summary
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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
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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%.

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

Conditions
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Temporomandibular Disorder

Intervention / Treatment
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* Drug: MD Muscle GUNA collagen
* Drug: Lidocaine 2% Injectable Solution
* Drug: Saline Solution, Hypertonic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: patients were divided into the three groups and examination and therapy was performed after 7 and 14 days
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MD Muscle Collagen group<br>Group with collagen intramuscular injections | Drug: MD Muscle GUNA collagen<br>* intramusclular injections of MD Muscle collagen<br>* Other names: intramuscular MD Muscle collagen injection;|
| Experimental: Lidocaine 2% group<br>Group with 2% Lidocaine intramuscular injections | Drug: Lidocaine 2% Injectable Solution<br>* intramuscular Lidocaine 2% injection<br>* Other names: intramuscular Lidocaine 2% injection;|
| Placebo Comparator: Saline<br>Group with 0,9% NaCl intramuscular injections | Drug: Saline Solution, Hypertonic<br>* intramuscular Saline injection<br>* Other names: intramuscular Saline injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sEMG reduction of masseter muscle in TMD patients | reduction of electromyograpic activity of masseter muscle | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TMD, collagen, intramuscular injection, trigger point