Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: February 2014

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.

Interventions

  • 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.
  • 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.
  • 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: 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”,

Arms, Groups and Cohorts

  • Active Comparator: acupuncture positive communication
    • Genuine acupuncture needles combined with positive communication regarding the expected treatment effects
  • Sham Comparator: sham acupuncture positive communication
    • Sham acupuncture needles combined with positive communication regarding the expected treatment effects
  • Active Comparator: acupuncture neutral communication
    • Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects
  • Sham Comparator: sham acupuncture neutral communication
    • Sham acupuncture needles combined with neutral communication regarding the expected treatment effects

Clinical Trial Outcome Measures

Primary Measures

  • Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

Inclusion Criteria

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

Exclusion Criteria

  • No acupuncture training

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Principal Investigator: Mats Lekander, Professor – Karolinska Institutet

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