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临床试验/NCT03323567
NCT03323567已完成早期 1 期

A Comparison of Collagen, Lidocaine and Saline Intramuscular Injections, in Myofascial Pain Patients With Trigger Points in Masseter Muscle.

Medical University of Silesia1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2016年1月10日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Group with collagen intramuscular injections

干预措施: MD Muscle GUNA collagen (Drug)

Lidocaine 2% group

Experimental

Group with 2% Lidocaine intramuscular injections

干预措施: Lidocaine 2% Injectable Solution (Drug)

Saline

Placebo Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aleksandra Nitecka-Buchta

Principal Investigator D.M.D. PhD

Medical University of Silesia

研究点 (1)

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