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Validation of a Non-Invasive Sham Technique

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ClinicalTrials.gov Identifier: NCT04960176
Recruitment Status : Recruiting
First Posted : July 13, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
Pınar Erdoğan, Nigde Omer Halisdemir University

Brief 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. Additionally, the reactions of the volunteers to sham needles in different positions and in different parts of the body will be investigated.

Condition or disease Intervention/treatment Phase
Acupuncture Procedure: Acupuncture Procedure: Non-invasive Sham Acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Development and Validation of Non-Invasive Sham Technique Using Blunted Acupuncture Needle
Actual Study Start Date : July 1, 2021
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Active Comparator: 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.
Procedure: Acupuncture
Acupuncture will be applied by using 0,25x25mm needles.

Sham Comparator: 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.
Procedure: Non-invasive Sham Acupuncture
Non-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • The healthy attendants of patients referred to General Surgery outpatient clinic

Exclusion Criteria:

  • presence of any diagnosed disease
  • on any regular medication
  • skin reaction on the area of planned acupuncture administration
  • neurologic sequela

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04960176


Contacts
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Contact: Pınar Erdoğan, MD 05323646954 pinarerdogan@ohu.edu.tr

Locations
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Turkey
Niğde Ömer Halisdemir University Research and Training Hospital Recruiting
Niğde, Turkey
Contact: Alirıza Erdoğan, MD         
Sponsors and Collaborators
Nigde Omer Halisdemir University
Investigators
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Principal Investigator: Pınar Erdoğan, MD Niğde Ömer Halisdemir University Midwifery Department
Publications:
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Responsible Party: Pınar Erdoğan, Principal Investigator, Nigde Omer Halisdemir University
ClinicalTrials.gov Identifier: NCT04960176    
Other Study ID Numbers: 08.06.2021/31
First Posted: July 13, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No