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临床试验/NCT06669910
NCT06669910已完成不适用

Investıgatıon of Temporomandıbular Dysfunctıon in Patıents Wıth Breast Cancer-Related Lymphedema

arife akbulut1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
1
主要终点
temporomandibular dysfunction

研究概览

简要总结

This study is the first study to examine temporomandibular joint dysfunction (TMD) in patients with breast cancer. The aim of the study was to investigate the relationship between lymphedema (LÖ) and TMD in patients with breast cancer. Socio-demographic characteristics of 38 individuals included in the study were recorded. Patients were divided into stage 0, 1 and 2 groups according to their LÖ stage and mild, moderate and advanced groups according to their TMD levels. In the evaluation of severity of lymphedema, Symptoms and Signs of TMD, pain threshold and tolerance assessment and normal range of motion, anxiety and depression, posture analysis environmental measurement, Craniomandibular Dysfunction Index for Clinical, Visual Analogue Scale (VAS) and algometer , goniometer and inclinometer, Turkish version of the Hospital Anxiety and Depression Scale (HAD) ,photogrammetric assessment method and inclinometer were used

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18-75 years who were treated for unilateral breast cancer and developed breast cancer-related LE were included in the study

排除标准

  • Patients with general joint diseases affecting the head and neck region that may cause TMD (e.g. rheumatoid arthritis),
  • jaw fracture,
  • trauma or orthognathic surgery history,
  • cervical disc herniation,
  • congenital disease,
  • facial paralysis,
  • patients who have been treated for TMD for the last 3 months and patients who use antidepressant drugs were excluded.

结局指标

主要结局

temporomandibular dysfunction

时间窗: through study completion, an average of 1 year

The Clinical Craniomandibular Dysfunction Index (CDI) was used. CDI consists of five components including limited mandibular normal joint motion (RMJ), pain during mandibular RMJ, pain during TMJ palpation, pain during palpation of masticatory muscles and pain during mandibular function. 3 points can be given for each component as 0, 1 or 5 points and individuals are graded as no TMD (0 points), mild TMD (1-4 points), moderate TMD (5-9 points) and severe TMD (10-25 points) according to the scores received.

lymhedema

时间窗: through study completion, an average of 1 year

It was determined according to the criteria determined by the International Lymphology Association . To determine the severity of LE, circumference measurements were taken from both arms at 4 cm intervals. If the difference between the two extremities was up to 1.5 cm, it was classified as "normal", between 1.5-3 cm as "mild", between 3-5 cm as "moderate" and over 5 cm as "severe" LE

次要结局

  • pain(through study completion, an average of 1 year)
  • posture(through study completion, an average of 1 year)
  • Measurement of range of motion of cervical joints and shoulder joint(through study completion, an average of 1 year)
  • anxiety-depression(through study completion, an average of 1 year)

研究者

发起方
arife akbulut
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

arife akbulut

LECTURER

Ankara Yildirim Beyazıt University

研究点 (1)

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