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临床试验/NCT03441698
NCT03441698已完成不适用

Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture, Given by Therapists Delivering Positive or Neutral Communication Regarding Expected Effects

Västernorrland County Council, Sweden0 个研究点目标入组 363 人开始时间: 2013年9月1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
363
主要终点
Change in relaxation from pre to post treatment.

研究概览

简要总结

Background: The communication between a patient and clinician may have significant effects on treatment outcomes and one likely mediator of the communication-related treatment effects is patient expectations, as demonstrated by placebo studies in various clinical domains. To investigate the link between patient-clinician interactions and patient expectancy in a clinical setting, acupuncture is suggested an effective method, as acupuncture is a procedure with known non-specific treatment components. As a scene for investigating the importance of expectations on treatment outcomes, the investigators used acupuncture for relaxation effects. It is commonly reported that participants experience a sense of relaxation during acupuncture treatment, yet, it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure.

Aim: To investigate if communication type (positive or neutral) about the expected treatment outcome affected i) participants' expectations, ii) short-term relaxation effects in response to genuine or sham acupuncture or to rest, and to investigate if treatment expectations were related to outcome.

Procedure: Volunteers, i.e. Swedish individuals in general, not part of any specific patient group, are given written and oral study information and are screened for study criteria. The volunteers giving informed consent are randomized to one treatment session a´30 minutes with a) genuine acupuncture or b) sham acupuncture (telescopic non-penetrating needles).

They are compared to a non-randomized reference group that receive no acupuncture, just 30 minutes of rest.

Within the three groups, participants are randomized to 1) positive communication or 2) neutral communication from therapists, regarding expected treatment effects.

Outcome measures: Visual analogue scales (VAS) (0-100 millimeter) measured treatment expectations and relaxation, at baseline two hours before the treatment session, pre treatment (directly before the treatment session) and post treatment (directly after the treatment session). Heart rate, blood pressure, and salivary cortisol are measured pre and post treatment. Primary endpoint is change in relaxation pre to post treatment.

详细描述

Background: The communication between a patient and clinician may have significant effects on treatment outcomes and one likely mediator of the communication-related treatment effects is patient expectations, as demonstrated by placebo studies in various clinical domains. To investigate the link between patient-clinician interactions and patient expectancy in a clinical setting, acupuncture is suggested an effective method, as acupuncture is a procedure with known non-specific treatment components. As a scene for investigating the importance of expectations on treatment outcomes, the investigators used acupuncture for relaxation effects. It is commonly reported that participants experience a sense of relaxation during acupuncture treatment, yet, it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure.

Aim: To investigate if communication type (positive or neutral) about the expected treatment outcome affected i) participants' expectations, ii) short-term relaxation effects in response to genuine or sham acupuncture or to rest, and to investigate if treatment expectations were related to outcome.

Procedure: Volunteers, i.e. Swedish individuals in general, not part of any specific patient group, are given written and oral study information and are screened for study criteria. The volunteers giving informed consent are blinded randomized, by use of a computerized random table, to one treatment session a´30 minutes with a) genuine manual acupuncture delivered to the traditional acupuncture point PC6 or b) sham acupuncture delivered to a sham acupuncture point at the double distance to the wrist compared to the PC6, using telescopic non-penetrating needles. The acupuncture treatments (genuine or sham) was given by one of nine physiotherapists.

They are compared to a non-randomized reference group that receive no acupuncture, just a treatment of 30 minutes of rest, given by one of three physiotherapists according to a standardized treatment protocol.

Within the three groups (genuine acupuncture, sham acupuncture or no acupuncture, just rest), the participants are randomized to 1) positive communication or 2) neutral communication from therapists according to a standardized treatment protocol, regarding expected treatment effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, 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

  • minimum age 18 years,
  • physical, mental and linguistic capacity to give informed consent, e.g. understand Swedish

排除标准

  • previous education in acupuncture therapy, in terms of being an acupuncture therapist.

研究组 & 干预措施

Genuine acupuncture (A)

Experimental

Genuine acupuncture (A) with neutral communication (A1) or positive communication (A2)

干预措施: Genuine acupuncture (A) (Device)

Sham Acupuncture (B)

Placebo Comparator

Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)

干预措施: Sham acupuncture (B) (Device)

Rest (C)

Active Comparator

Rest (C) with neutral communication (C1) or positive communication (C2)

干预措施: Rest (Other)

结局指标

主要结局

Change in relaxation from pre to post treatment.

时间窗: Directly before treatment and directly after treatment.

Visual Analogue Scale (VAS) 0-100 mm, where 0 is "not relaxed at all" and 100 is "completely relaxed".

次要结局

  • The participant´s Health status(Two hours before treatment)
  • Change in systolic Blood pressure in mm Hg(Directly before treatment and directly after treatment)
  • Change in treatment expectations(Two hours before treatment, directly before and directly after treatment)
  • Change in diastolic Blood pressure in mm Hg(Directly before treatment and directly after treatment)
  • Change in Heart rate in beats per minute(Directly before treatment and directly after treatment)

研究者

发起方
Västernorrland County Council, Sweden
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ylva Widgren

Study coordinator

Linkoeping University

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