Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation

Phase 4

Completed

• Conditions: Healthy
• Interventions: Procedure: acupuncture; Procedure: sham acupuncture; Procedure: positive communication; Procedure: neutral communication

• Registration Number: NCT02525445
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.

Detailed Description

Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.

Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.

Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.

Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-14
• Study First Posted: 2015-08-17
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Over 18 years of age
• Able to understand and read/write Swedish

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Exclusion Criteria

• No acupuncture training

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
acupuncture neutral communication	acupuncture	Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects
sham acupuncture positive communication	positive communication	Sham acupuncture needles combined with positive communication regarding the expected treatment effects
acupuncture positive communication	positive communication	Genuine acupuncture needles combined with positive communication regarding the expected treatment effects
acupuncture neutral communication	neutral communication	Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects
acupuncture positive communication	acupuncture	Genuine acupuncture needles combined with positive communication regarding the expected treatment effects
sham acupuncture positive communication	sham acupuncture	Sham acupuncture needles combined with positive communication regarding the expected treatment effects
sham acupuncture neutral communication	neutral communication	Sham acupuncture needles combined with neutral communication regarding the expected treatment effects
sham acupuncture neutral communication	sham acupuncture	Sham acupuncture needles combined with neutral communication regarding the expected treatment effects

Primary Outcome Measures

Name	Time	Method
Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)	approximately 5 minutes before treatment and approximately 5 minutes after treatment	Subjective perception of relaxation measured with a 0-100 mm Visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Change from before treatment to after treatment in subjective report of expectations (0-100 mm Visual analogue scale)	approximately 5 minutes before treatment and approximately 5 minutes after treatment	Subjective perception of expectation measured with a 0-100 mm Visual analogue scale