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临床试验/NCT01390454
NCT01390454已完成不适用

Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain

Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)

研究概览

简要总结

Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • for Tennis Elbow patients:
  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 90 days of follow up
  • Pain when pressure applied to the epicondyl
  • Pain upon forced movement of both epicondylien muscles
  • Absence of pain upon forced movement of an epitrochlear muscle
  • Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow
  • at least one consult for pain treatment associated with tennis elbow (on the same elbow)
  • Inclusion Criteria for healthy volunteers:
  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • No pain when pressure applied to the epicondyl
  • No pain upon forced movement of both epicondylien muscles
  • No neck pain
  • No skeletal-muscle problems in the arms during the 3 months preceding the study

排除标准

  • for Tennis Elbow patients:
  • The patient is included in another study
  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • The patient is breastfeeding
  • Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow
  • Exclusion Criteria for Health Volunteers:
  • The subject is included in another study
  • The subject is in an exclusion period determined by a previous study
  • The subject is under judicial protection, under tutorship or curatorship
  • The subject refuses to sign the consent
  • It is impossible to correctly inform the subject
  • Presence of one or more skeletal-muscle problems in the arms within the 3 months preceding the study
  • Pain when pressure applied to the epicondyl
  • Pain upon forced movement of both epicondylien muscles
  • Consultation for any kind of treatment for elbow pain

研究组 & 干预措施

Tennis elbow patients

Experimental

These patients have tennis elbow, according to stated inclusion criteria.

干预措施: Ultrasound of the elbow 1, days 7 to 15 (Procedure)

Tennis elbow patients

Experimental

These patients have tennis elbow, according to stated inclusion criteria.

干预措施: Ultrasound of the elbow 2, days 7 to 15 (Procedure)

Tennis elbow patients

Experimental

These patients have tennis elbow, according to stated inclusion criteria.

干预措施: Ultrasound of the elbow 3, days 45 to 90 (Procedure)

Healthy volunteers

Active Comparator

Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness.

干预措施: Ultrasound of the elbow 1, days 7 to 15 (Procedure)

Healthy volunteers

Active Comparator

Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness.

干预措施: Ultrasound of the elbow 2, days 7 to 15 (Procedure)

结局指标

主要结局

Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)

时间窗: Days 7 to 15

The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.

Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)

时间窗: Days 7 to 15

The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.

次要结局

  • Visual Analog Scale for pain(Between days 45 and 90)
  • Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only(Between days 45 and 90)
  • Q-Dash Questionnaire(Between 45 and 90 days)
  • Thickness of the ECR longus and ECR brevis interface(Between days 7 and 15)
  • Thickness of the ECR -supinator interface(Between 7 and 15 days)

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (2)

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