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临床试验/NCT05540366
NCT05540366招募中不适用

Effects of Aerobic Exercise on Pain in Patients With Myogenous Temporomandibular Disorders and Suspicion of Central Sensitization: A Pilot Randomized Controlled Trial

Universitat Internacional de Catalunya1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)

研究概览

简要总结

Temporomandibular disorders are common in the general population, the myogenic subtype being the most frequent. Central sensitization seems to be present in this pathology, with a decreased pain pressure threshold observed in both local and remote areas. The best evidence-based treatment consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic exercise showed to be effective in subjects with chronic pain and central sensitization, by inducing an hypoalgesic effect. However, there isn't investigation about the effects of aerobic exercise in subjects with myogenic temporomandibular disorders and central sensitization. Thus, the aim of the pilot study is to determine if adding aerobic exercise to an effective physical therapy programme is more effective than physical therapy alone to improve pain pressure threshold in subjects with myogenic temporomandibular disorders and suspicion of central sensitization.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
  • A minimum score of 30 in the Central Sensitization Index
  • Positive FRT

排除标准

  • History of trauma, TMJ or cervical fracture the past three months
  • History of TMJ or cervical surgery
  • Systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant
  • History of cardiovascular diseases which contraindicate aerobic exercise
  • Current orthodontic treatment, splints for bruxism
  • Drug addiction, alcoholism
  • Pregnancy
  • Use of analgesic medication less than 48 hours before each data collection
  • Physical therapy treatment during the past three months

结局指标

主要结局

Change of baseline in Pain Pressure Threshold at 2 weeks, 1 month (final) and 3 months (post)

时间窗: Baseline - 2 weeks - 1 month (final) - 3 months

Bilateral measure with digital algometer: TMJ, masseter, temporal, SCOM, achilles Tendon

次要结局

  • Change of baseline in Pain intensity at 2 weeks, 1 month (final) and 3 months (post)(Baseline - 2 weeks - 1 month (final) - 3 months posts)
  • Change of baseline in Central Sensitization at 2 weeks, 1 month (final) and 3 months (post)(Baseline - 2 weeks - 1 month (final) - 3 months post)
  • Change of baseline in Jaw function at 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months post)
  • Change of baseline in Anxiety and depression at 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months posts)
  • Change of baseline in Jaw range of motion al 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months posts)
  • Change of baseline in Perceived change at 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months posts)
  • Change of baseline in Cervical global ROM at 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months post)
  • Change of baseline in Upper cervical ROM at 2 weeks, 1 month (final) and 3 months (post)(Baseline - 2 weeks - 1 month (final) - 3 months posts)
  • Change of baseline in Sleep Quality at 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months posts)
  • Change of baseline in Neck disability at 1 month (final) and 3 months (post)(Baseline - 1 month (final) - 3 months posts)

研究者

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

Flora Dantony

Physical therapy department

Universitat Internacional de Catalunya

研究点 (1)

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