Healthy VolunteersNCT03441698
Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture
A study testing Genuine acupuncture (A) and Rest in people with Healthy Volunteers, run by Västernorrland County Council, Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Genuine acupuncture (A) and Rest
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 363 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- minimum age 18 years,
- physical, mental and linguistic capacity to give informed consent, e.g. understand Swedish
Who cannot join
- previous education in acupuncture therapy, in terms of being an acupuncture therapist.
About this study
Official title: Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture, Given by Therapists Delivering Positive or Neutral Communication Regarding Expected Effects
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Genuine acupuncture (A), Sham acupuncture (B), Rest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genuine acupuncture (A)Device
- 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)Device
- 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.
RestOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Genuine acupuncture (A) | Experimental | Genuine acupuncture (A) with neutral communication (A1) or positive communication (A2) Receives: Device: Genuine acupuncture (A) |
| Sham Acupuncture (B) | Placebo comparator | Sham acupuncture (B) with neutral communication (B1) or positive communication (B2) Receives: Device: Sham acupuncture (B) |
| Rest (C) | Active comparator | Rest (C) with neutral communication (C1) or positive communication (C2) Receives: Other: Rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Directly before treatment and directly after treatment.
Secondary outcomes (5)
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".
Measured: Two hours before treatment, directly before and directly after treatment
The participant´s Health status
Euro Qol barometer, 0-100 mm, where 0 represents "worst Health imaginable" and 100 "best Health imaginable"
Measured: Two hours before treatment
Change in Heart rate in beats per minute
Digital wrist blood pressure monitor
Measured: Directly before treatment and directly after treatment
Change in systolic Blood pressure in mm Hg
Digital wrist blood pressure monitor
Measured: Directly before treatment and directly after treatment
Change in diastolic Blood pressure in mm Hg
Digital wrist blood pressure monitor
Measured: Directly before treatment and directly after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study startSep 2013
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 363 participants (actual)
Sponsor and investigators
- Lead sponsor
- Västernorrland County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Ylva Widgren, Linkoeping University
- Investigators
- Anna E Enblom, PhD, Principal investigator, County council of Östergötland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03441698
- Sponsor's protocol ID
- Relaxation001
- Status last verified
- Mar 2018
- First submitted
- 8 Feb 2018
- Last updated
- 29 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxing Effects of Acupuncture, Sham Acupuncture or no Acupuncture, Given by Therapists Delivering Positive or Neutral Communication Regarding Expected Effects
- ClinicalTrials.gov ID
- NCT03441698
- Acronym / sponsor ID
- Relaxation001
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Västernorrland County Council, SwedenOther government
- Collaborators
- Linkoeping University
- Study start
- Sep 2013 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Genuine acupuncture (A) | Experimental | Device: Genuine acupuncture (A)Genuine acupuncture (A) with neutral communication (A1) or positive communication (A2) |
| Sham Acupuncture (B) | Placebo comparator | Device: Sham acupuncture (B)Sham acupuncture (B) with neutral communication (B1) or positive communication (B2) |
| Rest (C) | Active comparator | Other: RestRest (C) with neutral communication (C1) or positive communication (C2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- minimum age 18 years,
- physical, mental and linguistic capacity to give informed consent, e.g. understand Swedish
Key exclusion criteria (1 listed)
- previous education in acupuncture therapy, in terms of being an acupuncture therapist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Genuine acupuncture (A) |
| 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. | Device | Sham Acupuncture (B) |
| RestC) 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. | Other | Rest (C) |
Primary outcome
Change in relaxation from pre to post treatment.
Time frame: Directly before treatment and directly after treatment.
Visual Analogue Scale (VAS) 0-100 mm, where 0 is "not relaxed at all" and 100 is "completely relaxed".
5 secondary outcomes
Change in treatment expectations
Time frame: Two hours before treatment, directly before and directly after treatment
The participant´s Health status
Time frame: Two hours before treatment
Change in Heart rate in beats per minute
Time frame: Directly before treatment and directly after treatment
Change in systolic Blood pressure in mm Hg
Time frame: Directly before treatment and directly after treatment
Change in diastolic Blood pressure in mm Hg
Time frame: Directly before treatment and directly after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna E Enblom, PhD principal investigator
County council of Östergötland
Questions about this trial
What is this clinical trial studying?
A study testing Genuine acupuncture (A) and Rest in people with Healthy Volunteers, run by Västernorrland County Council, Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in relaxation from pre to post treatment. (time frame: Directly before treatment and directly after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.