Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation (ACU)

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Procedure: acupuncture; Procedure: positive communication; Procedure: sham acupuncture; Procedure: neutral communication

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.

• Study Type: Interventional
• Enrollment (Actual): 243
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No acupuncture training

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: acupuncture positive communication; Genuine acupuncture needles combined with positive communication regarding the expected treatment effects	Procedure: acupuncture; acupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth. The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles. When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle.; Other Names: invasive acupuncture; Procedure: positive communication; During the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: "Many acupuncture studies have shown excellent results concerning relaxation effects", "Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension".
Sham Comparator: sham acupuncture positive communication; Sham acupuncture needles combined with positive communication regarding the expected treatment effects	Procedure: positive communication; During the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: "Many acupuncture studies have shown excellent results concerning relaxation effects", "Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension".; Procedure: sham acupuncture; sham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20]. Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration. A marking tube, identical for both acupuncture types, held the sham needle in place. The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no "needle sensation" occurred, and then lifted the needles up from the skin.; Other Names: placebo acupuncture
Active Comparator: acupuncture neutral communication; Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects	Procedure: acupuncture; acupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth. The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles. When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle.; Other Names: invasive acupuncture; Procedure: neutral communication; During the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: "During treatment you will just lie down and rest and I will not talk so much to you", "We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study",
Sham Comparator: sham acupuncture neutral communication; Sham acupuncture needles combined with neutral communication regarding the expected treatment effects	Procedure: sham acupuncture; sham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20]. Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration. A marking tube, identical for both acupuncture types, held the sham needle in place. The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no "needle sensation" occurred, and then lifted the needles up from the skin.; Other Names: placebo acupuncture; Procedure: neutral communication; During the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: "During treatment you will just lie down and rest and I will not talk so much to you", "We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study",

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: August 11, 2015
• First Submitted That Met QC Criteria: August 14, 2015
• First Posted (Estimate): August 17, 2015

Study Record Updates

• Last Update Posted (Estimate): August 18, 2015
• Last Update Submitted That Met QC Criteria: August 17, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: communication; relaxation; acupuncture therapy; placebo effects
• Other Study ID Numbers: ACU 2013/80-31