AcupunctureNCT04960176
Validation of a Non-Invasive Sham Technique
A study testing Acupuncture in people with Acupuncture, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial summary
The objective of this study is to develop, describe in detail and validate a feasible, cheap and convenient non-invasive sham acupuncture technique in order to use safely and repeatedly in future studies. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2021to 30 Nov 2022
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The healthy attendants of patients referred to General Surgery outpatient clinic
Who cannot join
- presence of any diagnosed disease
- on any regular medication
- skin reaction on the area of planned acupuncture administration
- neurologic sequela
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Niğde Ömer Halisdemir University Research and Training Hospital
Niğde
Alirıza Erdoğan, MD
About this study
Official title: Development and Validation of Non-Invasive Sham Technique Using Blunted Acupuncture Needle
The objective of this study is to develop, describe in detail and validate a feasible, cheap and convenient non-invasive sham acupuncture technique in order to use safely and repeatedly in future studies. Additionally, the reactions of the volunteers to sham needles in different positions and in different parts of the body will be investigated.
Read the detailed description
Following the Second World War, the evidence based research is the keystone of modern medicine applications. Randomized, placebo controlled and double/triple blinded clinical studies are the sine qua non of evidence based medicine. As a matter of course acupuncture which was defined as traditional and the main outcome was the clinical effects throughout the centuries, had its share form the tremendous evolution. For the past decades, studies on acupuncture are designed and prosecuted on the basis of randomized and placebo controlled trials.
In clinical trials for invasive modalities, placebo is the procedure that mimics the original procedure in order to provide objective comparison. These procedures are called as sham techniques and in acupuncture sham techniques are divided into two categories as invasive sham procedures and non-invasive sham procedures. Non-invasive sham is a technique that is designed to create a minor sensory stimulation in the absence of skin penetration using a placebo needle or any device imitating needle. In acupuncture practice it is a fact that sham procedures are non-inert and even can exert high therapeutic effect. Consequently, the main concern regarding the randomized controlled trials on acupuncture is that false negative rates might be misleadingly higher than acceptable values. The clinical therapeutic effects of non-invasive techniques are attributed to the activation of physiologic endogen systems due to the belief that acupuncture was applied although it was only sham. Non-invasive techniques need to be used in clinical trials designed to discriminate this mentioned effect from the point-specific effects of real acupuncture and non-specific effects obtained by skin penetration in invasive sham techniques.
The fact that sham techniques used in clinical studies are far from standardization inevitably increase the false negativity rates. In fact there are various techniques about non-invasive sham acupuncture. Blunted needles or plastic guide tube, nail, pencil point probe or even wooden skewers were used. Techniques are not described most of the time and majority of the studies lack standardization and validation of the non-invasive sham technique that is used. There are standard Park and Steinberger needles which were developed privately for non-invasive sham procedures. The advantage these latter needles is that the patient cannot see the application of the needle. Otherwise as in all non-invasive sham technique the needles do not penetrate the skin, the patient does not get the de chi sensation and the stimulation of the needles is not possible.
- Conditions
- Acupuncture
- Being tested
- Acupuncture, Non-invasive Sham Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Acupuncture will be applied by using 0,25x25mm needles.
Non-invasive Sham AcupunctureProcedure or surgery
Non-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture Group | Active comparator | Acupuncture will be administered to 5 different reel acupoints. The acupoints are Du20 in head, LI4 bilateral in hands and ST36 bilateral in legs. Receives: Procedure: Acupuncture |
| Non-Invasive Sham Acupuncture Group | Sham comparator | Non-invasive sham acupuncture using a blunted needle will be administered to 5 different reel acupoints. The acupoints are Du20 in head, LI4 bilateral in hands and ST36 bilateral in legs. Receives: Procedure: Non-invasive Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of Needle Penetrating the Skin
Measured by a question addressing if the patient felt any penetration through the skin or not. Answer 'YES' is interpreted as sham procedure successfully mimicks real acupuncture. Answer 'NO' is interpreted as a failure of sham procedure in mimicking real acupuncture.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Erdoğan, Nigde Omer Halisdemir University
- Investigators
- Pınar Erdoğan, MD, Principal investigator, Niğde Ömer Halisdemir University Midwifery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04960176
- Sponsor's protocol ID
- 08.06.2021/31
- Status last verified
- Apr 2022
- First submitted
- 6 Jul 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaptchuk TJ. Placebo Effects in Acupuncture. Med Acupunct. 2020 Dec 1;32(6):352-356. doi: 10.1089/acu.2020.1483. Epub 2020 Dec 16.
PubMed 33362886Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006 Apr;12(3):303-10. doi: 10.1089/acm.2006.12.303.
PubMed 16646730Lundeberg T, Lund I, Naslund J, Thomas M. The Emperors sham - wrong assumption that sham needling is sham. Acupunct Med. 2008 Dec;26(4):239-42. doi: 10.1136/aim.26.4.239.
PubMed 19098696Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009 Mar;15(3):213-6. doi: 10.1089/acm.2008.0356.
PubMed 19250001Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998 Summer;4(2):159-71. doi: 10.1089/acm.1998.4.159.
PubMed 9628206White AR, Filshie J, Cummings TM; International Acupuncture Research Forum. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001 Dec;9(4):237-45. doi: 10.1054/ctim.2001.0489.
PubMed 12184353Park JE, Ryu YH, Liu Y, Jung HJ, Kim AR, Jung SY, Choi SM. A literature review of de qi in clinical studies. Acupunct Med. 2013 Jun;31(2):132-42. doi: 10.1136/acupmed-2012-010279. Epub 2013 Mar 13.
PubMed 23486017
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Non-Invasive Sham Technique Using Blunted Acupuncture Needle
- ClinicalTrials.gov ID
- NCT04960176
- Acronym / sponsor ID
- 08.06.2021/31
- Conditions
- Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 13 Jul 2021 (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.
The objective of this study is to develop, describe in detail and validate a feasible, cheap and convenient non-invasive sham acupuncture technique in order to use safely and repeatedly in future studies. Additionally, the reactions of the volunteers to sham needles in different positions and in different parts of the body will be investigated.
Detailed description
Following the Second World War, the evidence based research is the keystone of modern medicine applications. Randomized, placebo controlled and double/triple blinded clinical studies are the sine qua non of evidence based medicine. As a matter of course acupuncture which was defined as traditional and the main outcome was the clinical effects throughout the centuries, had its share form the tremendous evolution. For the past decades, studies on acupuncture are designed and prosecuted on the basis of randomized and placebo controlled trials.
In clinical trials for invasive modalities, placebo is the procedure that mimics the original procedure in order to provide objective comparison. These procedures are called as sham techniques and in acupuncture sham techniques are divided into two categories as invasive sham procedures and non-invasive sham procedures. Non-invasive sham is a technique that is designed to create a minor sensory stimulation in the absence of skin penetration using a placebo needle or any device imitating needle. In acupuncture practice it is a fact that sham procedures are non-inert and even can exert high therapeutic effect. Consequently, the main concern regarding the randomized controlled trials on acupuncture is that false negative rates might be misleadingly higher than acceptable values. The clinical therapeutic effects of non-invasive techniques are attributed to the activation of physiologic endogen systems due to the belief that acupuncture was applied although it was only sham. Non-invasive techniques need to be used in clinical trials designed to discriminate this mentioned effect from the point-specific effects of real acupuncture and non-specific effects obtained by skin penetration in invasive sham techniques.
The fact that sham techniques used in clinical studies are far from standardization inevitably increase the false negativity rates. In fact there are various techniques about non-invasive sham acupuncture. Blunted needles or plastic guide tube, nail, pencil point probe or even wooden skewers were used. Techniques are not described most of the time and majority of the studies lack standardization and validation of the non-invasive sham technique that is used. There are standard Park and Steinberger needles which were developed privately for non-invasive sham procedures. The advantage these latter needles is that the patient cannot see the application of the needle. Otherwise as in all non-invasive sham technique the needles do not penetrate the skin, the patient does not get the de chi sensation and the stimulation of the needles is not possible.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture Group | Active comparator | Procedure: AcupunctureAcupuncture will be administered to 5 different reel acupoints. The acupoints are Du20 in head, LI4 bilateral in hands and ST36 bilateral in legs. |
| Non-Invasive Sham Acupuncture Group | Sham comparator | Procedure: Non-invasive Sham AcupunctureNon-invasive sham acupuncture using a blunted needle will be administered to 5 different reel acupoints. The acupoints are Du20 in head, LI4 bilateral in hands and ST36 bilateral in legs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The healthy attendants of patients referred to General Surgery outpatient clinic
Key exclusion criteria (4 listed)
- presence of any diagnosed disease
- on any regular medication
- skin reaction on the area of planned acupuncture administration
- neurologic sequela
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 |
|---|---|---|
| AcupunctureAcupuncture will be applied by using 0,25x25mm needles. | Procedure or surgery | Acupuncture Group |
| Non-invasive Sham AcupunctureNon-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles. | Procedure or surgery | Non-Invasive Sham Acupuncture Group |
Primary outcome
Perception of Needle Penetrating the Skin
Time frame: Through study completion, an average of 3 months
Measured by a question addressing if the patient felt any penetration through the skin or not. Answer 'YES' is interpreted as sham procedure successfully mimicks real acupuncture. Answer 'NO' is interpreted as a failure of sham procedure in mimicking real acupuncture.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
- Background: PubMed 33362886Kaptchuk TJ. Placebo Effects in Acupuncture. Med Acupunct. 2020 Dec 1;32(6):352-356. doi: 10.1089/acu.2020.1483. Epub 2020 Dec 16.
- Background: PubMed 16646730Birch S. A review and analysis of placebo treatments, placebo effects, and placebo controls in trials of medical procedures when sham is not inert. J Altern Complement Med. 2006 Apr;12(3):303-10. doi: 10.1089/acm.2006.12.303.
- Background: PubMed 19098696Lundeberg T, Lund I, Naslund J, Thomas M. The Emperors sham - wrong assumption that sham needling is sham. Acupunct Med. 2008 Dec;26(4):239-42. doi: 10.1136/aim.26.4.239.
- Background: PubMed 19250001Moffet HH. Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. J Altern Complement Med. 2009 Mar;15(3):213-6. doi: 10.1089/acm.2008.0356.
- Background: PubMed 9628206Hammerschlag R. Methodological and ethical issues in clinical trials of acupuncture. J Altern Complement Med. 1998 Summer;4(2):159-71. doi: 10.1089/acm.1998.4.159.
- Background: PubMed 12184353White AR, Filshie J, Cummings TM; International Acupuncture Research Forum. Clinical trials of acupuncture: consensus recommendations for optimal treatment, sham controls and blinding. Complement Ther Med. 2001 Dec;9(4):237-45. doi: 10.1054/ctim.2001.0489.
- Background: PubMed 23486017Park JE, Ryu YH, Liu Y, Jung HJ, Kim AR, Jung SY, Choi SM. A literature review of de qi in clinical studies. Acupunct Med. 2013 Jun;31(2):132-42. doi: 10.1136/acupmed-2012-010279. Epub 2013 Mar 13.
- Individual participant dataSharing planned: No
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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.
Pınar Erdoğan, MD principal investigator
Niğde Ömer Halisdemir University Midwifery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pınar Erdoğan, MD (05323646954, pinarerdogan@ohu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of Needle Penetrating the Skin (time frame: Through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04960176, which also lists 7 linked publications.
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 5 Apr 2022.