Clinical trial NCT03441698: Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture
Official title: Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture, Given by Therapists Delivering Positive or Neutral Communication Regarding Expected Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: Västernorrland County Council, Sweden
Sponsor class: OTHER_GOV
Collaborators: name: Linkoeping University
First posted: 2018-02-22
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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 blinded randomized, by use of a computerized random table, to one treatment session a´30 minutes with a) genuine manual acupuncture delivered to the traditional acupuncture point PC6 or b) sham acupuncture delivered to a sham acupuncture point at the double distance to the wrist compared to the PC6, using telescopic non-penetrating needles. The acupuncture treatments (genuine or sham) was given by one of nine physiotherapists.

They are compared to a non-randomized reference group that receive no acupuncture, just a treatment of 30 minutes of rest, given by one of three physiotherapists according to a standardized treatment protocol.

Within the three groups (genuine acupuncture, sham acupuncture or no acupuncture, just rest), the participants are randomized to 1) positive communication or 2) neutral communication from therapists according to a standardized treatment protocol, regarding expected treatment effects.

The participants are blinded to type of acupuncture and communication type. The investigator entering data is blinded to treatment type and communication type. The evaluator is blinded to treatment type and communication type.

Outcome measures: Visual analogue scales (VAS) (0-100 millimeter) measure treatment expectations and level of relaxation, muscle tensions and stress 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 level of relaxation pre to post treatment.

Eligibility criteria: Inclusion Criteria:

* minimum age 18 years,
* physical, mental and linguistic capacity to give informed consent, e.g. understand Swedish

Exclusion Criteria:

* previous education in acupuncture therapy, in terms of being an acupuncture therapist.

Primary outcomes:
measure: Change in relaxation from pre to post treatment.
timeFrame: Directly before treatment and directly after treatment.
Secondary outcomes:
measure: Change in treatment expectations
timeFrame: Two hours before treatment, directly before and directly after treatment
measure: The participant´s Health status
timeFrame: Two hours before treatment
measure: Change in Heart rate in beats per minute
timeFrame: Directly before treatment and directly after treatment
measure: Change in systolic Blood pressure in mm Hg
timeFrame: Directly before treatment and directly after treatment
measure: Change in diastolic Blood pressure in mm Hg
timeFrame: Directly before treatment and directly after treatment
Other outcomes:
Locations:
Study officials:
affiliation: County council of Östergötland
name: Anna E Enblom, PhD
role: PRINCIPAL_INVESTIGATOR
References: