Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2013
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.
Epistemonikos ID: 92851bd7a7182a7715d71ecd103577ef7d8bd035
First added on: May 21, 2024