HealthyPhase 4ACUNCT02525445
Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation
A Phase 4 study testing acupuncture, positive communication and neutral communication in people with Healthy, run by Karolinska Institutet.
Trial summary
The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- acupuncture, positive communication and neutral communication
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Feb 2014
- Phase
- Phase 4
- 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
- Over 18 years of age
- Able to understand and read/write Swedish
Who cannot join
- No acupuncture training
About this study
The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.
Read the detailed description
Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.
Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.
Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.
Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.
- Conditions
- Healthy
- Being tested
- acupuncture, sham acupuncture, positive communication, neutral communication
- Keywords
- placebo effects, communication, acupuncture therapy, relaxation
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
Also called invasive acupuncture
acupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth. The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles. When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle.
sham acupunctureProcedure or surgery
Also called placebo acupuncture
sham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20]. Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration. A marking tube, identical for both acupuncture types, held the sham needle in place. The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no "needle sensation" occurred, and then lifted the needles up from the skin.
positive communicationProcedure or surgery
During the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: "Many acupuncture studies have shown excellent results concerning relaxation effects", "Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension".
neutral communicationProcedure or surgery
During the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: "During treatment you will just lie down and rest and I will not talk so much to you", "We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study",
| Study group | Role | What they receive |
|---|---|---|
| acupuncture positive communication | Active comparator | Genuine acupuncture needles combined with positive communication regarding the expected treatment effects Receives: Procedure: acupuncture; Procedure: positive communication |
| sham acupuncture positive communication | Sham comparator | Sham acupuncture needles combined with positive communication regarding the expected treatment effects Receives: Procedure: sham acupuncture; Procedure: positive communication |
| acupuncture neutral communication | Active comparator | Genuine acupuncture needles combined with neutral communication regarding the expected treatment effects Receives: Procedure: acupuncture; Procedure: neutral communication |
| sham acupuncture neutral communication | Sham comparator | Sham acupuncture needles combined with neutral communication regarding the expected treatment effects Receives: Procedure: sham acupuncture; Procedure: neutral communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)
Subjective perception of relaxation measured with a 0-100 mm Visual analogue scale
Measured: approximately 5 minutes before treatment and approximately 5 minutes after treatment
Secondary outcomes (1)
Change from before treatment to after treatment in subjective report of expectations (0-100 mm Visual analogue scale)
Subjective perception of expectation measured with a 0-100 mm Visual analogue scale
Measured: approximately 5 minutes before treatment and approximately 5 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2015 (estimated)
- Study startSep 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Lekander, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525445
- Sponsor's protocol ID
- ACU 2013/80-31
- Acronym
- ACU
- Status last verified
- Aug 2015
- First submitted
- 11 Aug 2015
- Last updated
- 18 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Genuine vs Sham Acupuncture and Communication Type on Relaxation
- ClinicalTrials.gov ID
- NCT02525445
- Acronym / sponsor ID
- ACU / ACU 2013/80-31
- Conditions
- Healthy
- Keywords
- placebo effects, communication, acupuncture therapy, relaxation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 17 Aug 2015 (estimated)
- 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.
The purpose of this study is to investigate if it is possible to influence the participants' expectations to improve outcome, in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects.
Detailed description
Background It is commonly reported that individuals experience a sense of relaxation during acupuncture treatment. However it is not known if the effects are related to the specific effects of needling or non-specific effects associated with the treatment procedure e.g. the communication with the therapist. It is well known that the way in which patients and clinicians communicate with each other affect treatment outcome, and one of the possible mechanisms to mediate the communication-related treatment outcomes is patient expectations.
Aims The aim of the study is therefore to investigate if it is possible to influence the individuals' expectations to improve outcome; in this particular setting the relaxing effects of one single acupuncture treatment with genuine or sham needles combined with positive or neutral communication regarding expected relaxing effects. The investigators also aim to investigate if different therapists influence how individuals perceive treatment effects, blinding and the communication during treatment with genuine and sham acupuncture.
Procedure Nine therapists performed treatments on voluntary healthy individuals who were randomized to a 30 minute treatment session with a) genuine penetrating acupuncture in traditional acupuncture points or b) non-penetrating sham needles in sham points. Within groups, individuals were further randomized to two communication styles 1) neutral communication or 2) strengthened positive communication regarding expectations concerning relaxing effects.
Outcome measures Perceived degree of expectancy and relaxation was measured directly before and after the treatment. The individuals also rated how they experienced the therapist´s communication style regarding grade of positivity and if they believed that the therapist had given them genuine or sham acupuncture directly after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acupuncture positive communication | Active comparator | Procedure: acupuncture, Procedure: positive communicationGenuine acupuncture needles combined with positive communication regarding the expected treatment effects |
| sham acupuncture positive communication | Sham comparator | Procedure: sham acupuncture, Procedure: positive communicationSham acupuncture needles combined with positive communication regarding the expected treatment effects |
| acupuncture neutral communication | Active comparator | Procedure: acupuncture, Procedure: neutral communicationGenuine acupuncture needles combined with neutral communication regarding the expected treatment effects |
| sham acupuncture neutral communication | Sham comparator | Procedure: sham acupuncture, Procedure: neutral communicationSham acupuncture needles combined with neutral communication regarding the expected treatment effects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 18 years of age
- Able to understand and read/write Swedish
Key exclusion criteria (1 listed)
- No acupuncture training
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 |
|---|---|---|
| acupunctureAlso: invasive acupunctureacupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth. The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles. When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle. | Procedure or surgery | acupuncture neutral communication, acupuncture positive communication |
| sham acupunctureAlso: placebo acupuncturesham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20]. Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration. A marking tube, identical for both acupuncture types, held the sham needle in place. The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no "needle sensation" occurred, and then lifted the needles up from the skin. | Procedure or surgery | sham acupuncture neutral communication, sham acupuncture positive communication |
| positive communicationDuring the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: "Many acupuncture studies have shown excellent results concerning relaxation effects", "Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension". | Procedure or surgery | acupuncture positive communication, sham acupuncture positive communication |
| neutral communicationDuring the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: "During treatment you will just lie down and rest and I will not talk so much to you", "We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study", | Procedure or surgery | acupuncture neutral communication, sham acupuncture neutral communication |
Primary outcome
Change from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale)
Time frame: approximately 5 minutes before treatment and approximately 5 minutes after treatment
Subjective perception of relaxation measured with a 0-100 mm Visual analogue scale
1 secondary outcome
Change from before treatment to after treatment in subjective report of expectations (0-100 mm Visual analogue scale)
Time frame: approximately 5 minutes before treatment and approximately 5 minutes 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 18 Aug 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing acupuncture, positive communication and neutral communication in people with Healthy, run by Karolinska Institutet.
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 18 Aug 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 from before treatment to after treatment in subjective report of relaxation (0-100 mm Visual analogue scale) (time frame: approximately 5 minutes before treatment and approximately 5 minutes 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 18 Aug 2015.