Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation

NCT02525445 | Completed Phase 4

• 1 other identifier: ACU 2013/80-31
• Study Type: interventional
• Target: 243
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

placebo effects; communication; acupuncture therapy; relaxation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

acupuncture positive communication

ACTIVE COMPARATOR

Genuine acupuncture needles combined with positive communication regarding the expected treatment effects

Procedure: acupuncture; Procedure: positive communication

sham acupuncture positive communication

SHAM COMPARATOR

Sham acupuncture needles combined with positive communication regarding the expected treatment effects

Procedure: sham acupuncture; Procedure: positive communication

acupuncture neutral communication

ACTIVE COMPARATOR

Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects

Procedure: acupuncture; Procedure: neutral communication

sham acupuncture neutral communication

SHAM COMPARATOR

Sham acupuncture needles combined with neutral communication regarding the expected treatment effects

Procedure: sham acupuncture; Procedure: neutral communication

Interventions

acupuncture PROCEDURE

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.

Also known as: invasive acupuncture

acupuncture neutral communication; acupuncture positive communication

sham acupuncture PROCEDURE

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.

Also known as: placebo acupuncture

sham acupuncture neutral communication; sham acupuncture positive communication

positive communication PROCEDURE

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".

acupuncture positive communication; sham acupuncture positive communication

neutral communication PROCEDURE

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",

acupuncture neutral communication; sham acupuncture neutral communication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No acupuncture training

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Communication

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 17, 2015
• Study Start: September 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: August 18, 2015

Record last verified: 2015-08