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

Medical University of Silesia

Status and phase: Completed; Early Phase 1

Conditions: Temporomandibular Disorder

Treatments: Drug: MD Muscle GUNA collagen; Drug: Lidocaine 2% Injectable Solution; Drug: Saline Solution, Hypertonic

Study type: Interventional

Funder types: Other

Identifiers

NCT03323567

Silesian UM

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 43 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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43 participants in 3 patient groups, including a placebo group

MD Muscle Collagen group

Experimental group

Description:

Group with collagen intramuscular injections

Treatment:

Drug: MD Muscle GUNA collagen

Lidocaine 2% group

Experimental group

Description:

Group with 2% Lidocaine intramuscular injections

Treatment:

Drug: Lidocaine 2% Injectable Solution

Saline

Placebo Comparator group

Description:

Group with 0,9% NaCl intramuscular injections

Treatment:

Drug: Saline Solution, Hypertonic