A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- sEMG reduction of masseter muscle in TMD patients
研究概览
简要总结
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.
详细描述
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%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sleep bruxism, DC/TMD myofascial pain, myofascial pain with referral
排除标准
- •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
研究组 & 干预措施
MD Muscle Collagen group
Group with collagen intramuscular injections
干预措施: MD Muscle GUNA collagen (Drug)
Lidocaine 2% group
Group with 2% Lidocaine intramuscular injections
干预措施: Lidocaine 2% Injectable Solution (Drug)
Saline
Group with 0,9% NaCl intramuscular injections
干预措施: Saline Solution, Hypertonic (Drug)
结局指标
主要结局
sEMG reduction of masseter muscle in TMD patients
时间窗: 14 days
reduction of electromyograpic activity of masseter muscle
次要结局
未报告次要终点
研究者
Aleksandra Nitecka-Buchta
Principal Investigator D.M.D. PhD
Medical University of Silesia
