An Early Phase 1 interventional study of MD Muscle GUNA collagen and Lidocaine 2% Injectable Solution in Temporomandibular Disorder, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-01-04.
Sponsored by Medical University of Silesia · Early Phase 1, Interventional, and Treatment
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.
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%.
591 studies on the registry are indexed under Temporomandibular Joint Disorders; 149 are open to participants now.
This study's enrollment of 43 is close to the median of 45 across 415 interventional studies indexed under Temporomandibular Joint Disorders.
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Exclusion Criteria:
Group with collagen intramuscular injections
Drug: MD Muscle GUNA collagen
Group with 2% Lidocaine intramuscular injections
Drug: Lidocaine 2% Injectable Solution
Group with 0,9% NaCl intramuscular injections
Drug: Saline Solution, Hypertonic
intramusclular injections of MD Muscle collagen
Also known as: intramuscular MD Muscle collagen injection
intramuscular Lidocaine 2% injection
Also known as: intramuscular Lidocaine 2% injection
intramuscular Saline injection
Also known as: intramuscular Saline injection
sEMG reduction of masseter muscle in TMD patients
reduction of electromyograpic activity of masseter muscle
Time frame: 14 days
Plan to share: Undecided
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Temporomandibular Joint Disorders →
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