Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture

Healthy Volunteers Clinical Trial

Official title:

Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture, Given by Therapists Delivering Positive or Neutral Communication Regarding Expected Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03441698
• Other study ID #: Relaxation001
• Status: Completed
• Phase: N/A
• First received: February 8, 2018
• Last updated: March 26, 2018
• Start date: September 2013
• Est. completion date: April 2017

Study information

• Verified date: March 2018
• Source: Västernorrland County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Device:
• Genuine acupuncture (A)
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.
• Sham acupuncture (B)
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.

Other:
• Rest
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Västernorrland County Council, Sweden	Linkoeping University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in treatment expectations	Visual Analogue Scale (VAS) 0-100 mm, where 0 represents "expects treatment to have no effect" and 100 represents "expects treatment to have full effect".	Two hours before treatment, directly before and directly after treatment
Secondary	The participant´s Health status	Euro Qol barometer, 0-100 mm, where 0 represents "worst Health imaginable" and 100 "best Health imaginable"	Two hours before treatment
Secondary	Change in Heart rate in beats per minute	Digital wrist blood pressure monitor	Directly before treatment and directly after treatment
Secondary	Change in systolic Blood pressure in mm Hg	Digital wrist blood pressure monitor	Directly before treatment and directly after treatment
Secondary	Change in diastolic Blood pressure in mm Hg	Digital wrist blood pressure monitor	Directly before treatment and directly after treatment