- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02396550
Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement
Influence of Patient Expectations With Lateral Epicondylalgia in Applying Mobilization With Movement. Clinical Trial
Lateral epicondylalgia affects people of both gender between 1 and 3% of the world population, with up to 15% in the working population reaching an average of 12 weeks off work for this reason. One of the conservative treatments that have shown effective is the mobilization with movement, whose mechanisms of action are not known. According Bialosky et al., possible effects of manual therapy are based on the neurophysiological mechanisms at peripheral, spinal and supraspinal level. Among the mechanisms to supraspinal level is the placebo effect, which is influenced by psychological factors such as conditioning and expectations.
Changing expectations to determine the influence on the treatment has been studied in healthy subjects, showing improvement with positive expectations and worsening to negative and neutral expectations.
However the result of modifying the previous expectations for treatment in patients with pain has not been studied.
The aim of our study is to test the influence that positive expectations have on the effectiveness of treatment with mobilization with movement in patients with lateral epicondylalgia.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Madrid
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Arganda del Rey, Madrid, 스페인, 28500
- Raúl Ferrer Peña
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Lateral Epicondylalgia Diagnosis
Exclusion Criteria:
- Previous Treatment with Manual Therapy
- Previous Treatment with injection 6 months before
- Radiculopathy
- Bilateral Symptoms
- Fracture
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Positive Expectations
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into positive
|
Give positive expectation of the treatment efficacy to patients
Give neutral expectation of the treatment efficacy to patients
|
|
실험적: Neutral Expectations
Procedure/Surgery: Mobilization with movement in patients with lateral epicondylalgia with modification of its expectations into neutral
|
Give neutral expectation of the treatment efficacy to patients
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain Intensity
기간: 0 - 10 days
|
measured with the Visual Analogue Scale (VAS)
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0 - 10 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Threshold Pressure Pain
기간: 0 - 10 days
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measured with algometry
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0 - 10 days
|
|
Perceived Disability
기간: 0-10 days
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with the DISABILITIES OF THE ARM, SHOULDER AND HAND (DASH) Questionnaire
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0-10 days
|
|
Kinesiophobia
기간: 0 - 10 days
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with the Tampa Scale of Kinesiophobia
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0 - 10 days
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Bialosky JE, George SZ, Horn ME, Price DD, Staud R, Robinson ME. Spinal manipulative therapy-specific changes in pain sensitivity in individuals with low back pain (NCT01168999). J Pain. 2014 Feb;15(2):136-48. doi: 10.1016/j.jpain.2013.10.005. Epub 2013 Oct 27.
- Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9. doi: 10.1179/2042618610Y.0000000001.
- Bialosky JE, Bishop MD, Robinson ME, Barabas JA, George SZ. The influence of expectation on spinal manipulation induced hypoalgesia: an experimental study in normal subjects. BMC Musculoskelet Disord. 2008 Feb 11;9:19. doi: 10.1186/1471-2474-9-19.
- Paungmali A, O'Leary S, Souvlis T, Vicenzino B. Hypoalgesic and sympathoexcitatory effects of mobilization with movement for lateral epicondylalgia. Phys Ther. 2003 Apr;83(4):374-83.
- Vicenzino B, Paungmali A, Buratowski S, Wright A. Specific manipulative therapy treatment for chronic lateral epicondylalgia produces uniquely characteristic hypoalgesia. Man Ther. 2001 Nov;6(4):205-12. doi: 10.1054/math.2001.0411.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Positive Expectations에 대한 임상 시험
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