A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.
| Registry | NCT03323567 |
|---|---|
| Status | Completed |
| Phase | Early Phase 1 |
| Study type | Interventional; randomized, crossover, masking: double, treatment |
| Enrollment | 43 (Actual) |
| Sponsor | Medical University of Silesia (Other) |
| Conditions | Temporomandibular Disorder |
| Interventions | MD Muscle GUNA collagen, Lidocaine 2% Injectable Solution, Saline Solution, Hypertonic (Drug) |
| Dates | start 2016-01-10, primary completion 2017-10-04, completion 2017-10-12, first posted 2017-10-27, last updated 2018-01-04 |
| Locations | 1 site in Poland |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Temporomandibular Disorder All trials of MD Muscle GUNA collagen All trials of Lidocaine 2% Injectable Solution
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%.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| MD Muscle Collagen group | Experimental | Drug: MD Muscle GUNA collagen | Group with collagen intramuscular injections |
| Lidocaine 2% group | Experimental | Drug: Lidocaine 2% Injectable Solution | Group with 2% Lidocaine intramuscular injections |
| Saline | Placebo comparator | Drug: Saline Solution, Hypertonic | Group with 0,9% NaCl intramuscular injections |
Sex: All, ages: 18 Years to 70 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Department of TMD and Orthodontics Silesian Medical University | Zabrze | Poland |