Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture

NCT03441698 | Completed

• 1 other identifier: Relaxation001
• Study Type: interventional
• Target: 363
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in relaxation from pre to post treatment.

  Visual Analogue Scale (VAS) 0-100 mm, where 0 is "not relaxed at all" and 100 is "completely relaxed".

  Directly before treatment and directly after treatment.

Secondary Outcomes (5)

• Change in treatment expectations

  Two hours before treatment, directly before and directly after treatment

• The participant´s Health status

  Two hours before treatment

• Change in Heart rate in beats per minute

  Directly before treatment and directly after treatment

• Change in systolic Blood pressure in mm Hg

  Directly before treatment and directly after treatment

• Change in diastolic Blood pressure in mm Hg

  Directly before treatment and directly after treatment

Study Arms (3)

Genuine acupuncture (A)

EXPERIMENTAL

Genuine acupuncture (A) with neutral communication (A1) or positive communication (A2)

Device: Genuine acupuncture (A)

Sham Acupuncture (B)

PLACEBO COMPARATOR

Sham acupuncture (B) with neutral communication (B1) or positive communication (B2)

Device: Sham acupuncture (B)

Rest (C)

ACTIVE COMPARATOR

Rest (C) with neutral communication (C1) or positive communication (C2)

Other: Rest

Interventions

Genuine acupuncture (A) DEVICE

A) Acupuncture is administered bilaterally to the acupuncture point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpii radialis. Sharp acupuncture needles were inserted into a depth of a half body-inch. The needles are manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurs. Within the groups A, B and C, the participants are randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected relaxing effects of their treatment, using a standardized communication model.

Genuine acupuncture (A)

Sham acupuncture (B) DEVICE

B) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6. The telescopic Park Sham Device was used. The needle looks identical to a real needle, but is blunt and glides upward into its handle instead of penetrating. The marking tubes holds the needle in place. The therapist give an illusion of manipulating the needle by turning it three times until it touched the skin, but no deqi occurs. Within the groups A, B and C, the participants are randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected relaxing effects of their treatment, using a standardized communication model.

Sham Acupuncture (B)

Rest OTHER

C) Rest means resting for 30 minutes, either sitting or lying down. Within the groups A, B and C, the participants are randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected relaxing effects of their treatment, using a standardized communication model.

Rest (C)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Västernorrland County Council, Sweden: lead
• Linkoeping University: collaborator

MeSH Terms

Interventions

RE1-silencing transcription factor

Study Officials

• Anna E Enblom, PhD

  County council of Östergötland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 22, 2018
• Study Start: September 1, 2013
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share