Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
56 participants
INTERVENTIONAL
2021-07-01
2022-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Acupuncture Group
Acupuncture will be administered to 5 different reel acupoints. The acupoints are Du20 in head, LI4 bilateral in hands and ST36 bilateral in legs.
Acupuncture
Acupuncture will be applied by using 0,25x25mm needles.
Non-Invasive Sham Acupuncture Group
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.
Non-invasive Sham Acupuncture
Non-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles.
Interventions
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Acupuncture
Acupuncture will be applied by using 0,25x25mm needles.
Non-invasive Sham Acupuncture
Non-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* on any regular medication
* skin reaction on the area of planned acupuncture administration
* neurologic sequela
18 Years
65 Years
ALL
Yes
Sponsors
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Nigde Omer Halisdemir University
OTHER
Responsible Party
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Pınar Erdoğan
Principal Investigator
Principal Investigators
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Pınar Erdoğan, MD
Role: PRINCIPAL_INVESTIGATOR
Niğde Ömer Halisdemir University Midwifery Department
Locations
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Niğde Ömer Halisdemir University Research and Training Hospital
Niğde, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Alirıza Erdoğan, MD
Role: primary
References
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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.
Birch 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.
Lundeberg 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.
Moffet 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.
Hammerschlag 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.
White 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.
Park 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.
Other Identifiers
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08.06.2021/31
Identifier Type: -
Identifier Source: org_study_id
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