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临床试验/NCT03400462
NCT03400462已完成不适用

Comparison of the Effectiveness of Three Different Treatment Methods in Myofascial Pain Patients

Pomeranian Medical University Szczecin0 个研究点目标入组 90 人开始时间: 2016年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
主要终点
Visual Analogue Scale

研究概览

简要总结

The aim of this study was to compare the effectiveness of myofascial pain treatment methods.

详细描述

Three different metoda were taken into account: dry needling, occlusal sprint therapy and NSAID therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • pain localized in the TMJ or in the preauricular area.
  • no other analgesic treatment in the area of head and neck during last 12 months

排除标准

  • inflammation in the oral cavity that emerge as a myofascial pain
  • earlier splint therapy
  • pharmacotherapy e.g oral contraception, hormone replacement therapy, -antidepressants
  • systemic diseases e.g. rheumatic, metabolic
  • lack of stability in the masticatory organ motor system
  • masticatory organ injury

研究组 & 干预措施

dry needling + oral appliance

Experimental

Three visits are needed in this therapy method. Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd) Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, solution for skin disinfection, sterile gauze. Exposition time : 30 minutes once a week

干预措施: oral appliance (Device)

dry needling + oral appliance

Experimental

Three visits are needed in this therapy method. Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd) Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, solution for skin disinfection, sterile gauze. Exposition time : 30 minutes once a week

干预措施: dry needling (Other)

antiinflammatory drugs + splint therapy

Experimental

Patient's instruction for NSAID use:

Nimesulide 2*100 mg/ 24 h- twice a day one pill of the 100 mg Nimesulide during 14 days

干预措施: NSAID (Drug)

antiinflammatory drugs + splint therapy

Experimental

Patient's instruction for NSAID use:

Nimesulide 2*100 mg/ 24 h- twice a day one pill of the 100 mg Nimesulide during 14 days

干预措施: oral appliance (Device)

splint therapy

Active Comparator

Splint therapy is an useful treatment method for several group of patients e.g TMD patients, patients with retrodiscitis, patients with muscle pain disorders like local muscle soreness or chronic myalgia.

The patients have been instructed to use the appliance during nighttime. After 7 days the patient had to came back for a control visit.

干预措施: oral appliance (Device)

结局指标

主要结局

Visual Analogue Scale

时间窗: 6 months

It is a continuous scale comprised of a horizontal line, usually 10 cm in length. "no pain" (score of 0) and "pain as bad as it could be (score of 10)

次要结局

未报告次要终点

研究者

发起方
Pomeranian Medical University Szczecin
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalewski Bartosz

DMD, PhD

Pomeranian Medical University Szczecin

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