Validation of a Non-Invasive Sham Technique

April 4, 2022 updated by: Pınar Erdoğan, Nigde Omer Halisdemir University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Niğde, Turkey
        • Recruiting
        • Niğde Ömer Halisdemir University Research and Training Hospital
        • Contact:
          • Alirıza Erdoğan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

November 30, 2022

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 10, 2021

First Posted (Actual)

July 13, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 08.06.2021/31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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