NCT04960176

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 5, 2022

Status Verified

April 1, 2022

Enrollment Period

1.4 years

First QC Date

July 6, 2021

Last Update Submit

April 4, 2022

Conditions

Acupuncture

Outcome Measures

Primary Outcomes (1)

  • 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.

    Through study completion, an average of 3 months

Study Arms (2)

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.

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.

Procedure: Non-invasive Sham Acupuncture

Interventions

AcupuncturePROCEDURE

Acupuncture will be applied by using 0,25x25mm needles.

Acupuncture Group
Non-invasive Sham AcupuncturePROCEDURE

Non-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles.

Non-Invasive Sham Acupuncture Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University Research and Training Hospital

Niğde, Turkey (Türkiye)

RECRUITING

Related Publications (7)

  • 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.

    PMID: 33362886BACKGROUND

  • 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.

    PMID: 16646730BACKGROUND

  • 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.

    PMID: 19098696BACKGROUND

  • 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.

    PMID: 19250001BACKGROUND

  • 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.

    PMID: 9628206BACKGROUND

  • 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.

    PMID: 12184353BACKGROUND

  • 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.

    PMID: 23486017BACKGROUND

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Pınar Erdoğan, MD

    Niğde Ömer Halisdemir University Midwifery Department

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pınar Erdoğan, MD

CONTACT

05323646954pinarerdogan@ohu.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2021

First Posted

July 13, 2021

Study Start

July 1, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

April 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)