- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05206383
Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles
Influence of Oral Messages on the Activity of Wrist and Finger Flexor Muscles - in the Context of Application of Sham Therapy
The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.
For years, research has been conducted on the effects of dynamic plaster and rigid plaster on muscle function. In many cases, reports from different authors are contradictory. Therefore, the planned study will use placebo paper plaster with no proven therapeutic effect.
연구 개요
상태
상세 설명
People's words can have a huge impact on how we interpret our surroundings, what we expect and experience, and how we behave. The placebo (and nocebo) effects are a clear example here. The way health professionals discuss, describe and inform patients about the characteristic effects of a given disease, its prevention, diagnosis and treatment influences patients' feelings and expectations, which in turn affects their psychobiological responses, subjective feelings and treatment outcomes.
The right choice of words by clinicians influences patients' response to medical treatments and procedures, both active and sham. The way in which information about the effects of treatment is communicated to patients can reinforce the outcomes of a particular treatment (placebo) or reverse clinically-proven effects of an active treatment, or even increase its adverse effects. The right messages can reduce the nocebo effect. And vice versa, the wrong choice of information provided may increase the patient's anxiety and disease symptoms.
The aim of the study will be to evaluate the effect of oral messages on wrist and finger flexor muscle activity during the application of sham therapy in the form of paper plaster.
Main hypothesis:
The use of a positive message will have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers.
Research questions:
- Does a positive message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?
- Does a negative message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers? Does a neutral message have an effect on increasing the activation and strength of the flexor muscles of the wrist joint and fingers?
The study will be a prospective, flow-up study using a differential variable in the form of the type of message used (positive - placebo, negative - nocebo, neutral). The respondents will be randomly allocated to study groups using sealed allocation sheets.
Before taking part in the study, each subject will be familiarised with the course of the study and must give written informed consent to participate in the study and to be randomly assigned to a specific study group.
The subjects will be assessed twice - before applying a paper plaster and 10 minutes after applying the plaster and delivering a voice message.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Biała Podlaska, 폴란드, 21-500
- Pope John Paul II State School Of Higher Education in Biała Podlaska
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- subjects not using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
- age - 19-24 years,
- written consent to participate in the study.
Exclusion Criteria:
- subjects studying for a degree in physiotherapy,
- subjects post surgery on the examined upper limb,
- subjects with past bone fractures in the examined upper limb,
- subjects who have had an injury to the examined upper limb within 6 months before the start of the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Positive message
Group A - 30 subjects who will be told that positive message.
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Subjects who will be told that "the applied plastering method significantly increases muscle strength" (positive message - placebo).
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실험적: Negative message
Group B - 30 subjects who will be told negative message.
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Subjects who will be told that "the applied plastering method has no effect on muscle strength" (negative message - nocebo).
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실험적: Neutral message
Group C - 30 people who will be told neutral message.
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Subjects who will be told that "the applied plastering method is currently under investigation and the investigators do not know its effects" (neutral message).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Dynamometer tests
기간: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
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Assessment of wrist and finger flexor muscle strength.
Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table.
The patient squeezes the dynamometer for a period of 3-5 seconds.
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Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Testing with Naroxon Ultimum EMG
기간: Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
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Assessment of wrist and finger flexor muscle activity. Patient in sitting position with the elbow joint on the examined side bent and the forearm resting on the table. The subject's arm is adducted, the wrist joint in an intermediate position. The electrodes are glued in the belly area of the flexor muscles of the wrist and fingers - about 2 cm from the medial epicondyle of the humerus in a distal direction at a distance of 1 cm from each other. The patient squeezes the dynamometer for a period of 3-5 seconds. |
Change in measured parameters 10 minutes after application of the plaster and delivery of the oral message relative to baseline measurement.
|
공동 작업자 및 조사자
수사관
- 연구 의자: Kamil Zaworski, FIZJOPERFEKT Kamil Zaworski
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PopeJohnPaulIIStateSchHigherE3
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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