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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-10

Study Completion Date

2017-10-12

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.

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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%.

Conditions

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Temporomandibular Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

patients were divided into the three groups and examination and therapy was performed after 7 and 14 days

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Participants and care providers had no knowledge about the substance prepared for the injection. The information for the main investigator was the number of patient and the number of injection

Study Groups

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MD Muscle Collagen group

Group with collagen intramuscular injections

Group Type EXPERIMENTAL

MD Muscle GUNA collagen

Intervention Type DRUG

intramusclular injections of MD Muscle collagen

Lidocaine 2% group

Group with 2% Lidocaine intramuscular injections

Group Type EXPERIMENTAL

Lidocaine 2% Injectable Solution

Intervention Type DRUG

intramuscular Lidocaine 2% injection

Saline

Group with 0,9% NaCl intramuscular injections

Group Type PLACEBO_COMPARATOR

Saline Solution, Hypertonic

Intervention Type DRUG

intramuscular Saline injection

Interventions

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MD Muscle GUNA collagen

intramusclular injections of MD Muscle collagen

Intervention Type DRUG

Lidocaine 2% Injectable Solution

intramuscular Lidocaine 2% injection

Intervention Type DRUG

Saline Solution, Hypertonic

intramuscular Saline injection

Intervention Type DRUG

Other Intervention Names

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intramuscular MD Muscle collagen injection intramuscular Lidocaine 2% injection intramuscular Saline injection

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No