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Related Concept Videos

Blind Procedures02:07

Blind Procedures

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Ideally, the people who observe and record the children’s behavior are unaware of who was assigned to the experimental or control group, in order to control for experimenter bias. Experimenter bias refers to the possibility that a researcher’s expectations might skew the results of the study. Remember, conducting an experiment requires a lot of planning, and the people involved in the research project have a vested interest in supporting their hypotheses. If the observers knew which...
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Blinding01:11

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Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
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Related Experiment Video

Updated: Sep 16, 2025

Preliminary Study on Acupuncture Combined with Grain-sized Moxibustion for Treating Rheumatoid Arthritis with Finger Joint Pain
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Introducing a novel sham acupuncture method for double-blind trials: A validation study.

Sung Min Lim1, Eunji Go1, Jungsup Lee2

  • 1Department of Clinical Rehabilitation Research, National Rehabilitation Research Institute, Seoul, Republic of Korea.

Complementary Therapies in Medicine
|July 6, 2025
PubMed
Summary

This study validated a new sham acupuncture method for clinical trials. While successful at blinding participants at one point (ST36), challenges remained at another (LI4), indicating a need for further research.

Keywords:
AcupunctureClinical trialDouble blind studySham treatment

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Area of Science:

  • Integrative and Complementary Medicine
  • Clinical Trial Methodology
  • Acupuncture Research

Background:

  • Designing adequate control groups for acupuncture effectiveness studies is challenging.
  • Sham acupuncture tools aim to mimic real acupuncture without skin penetration but their efficacy is debated.
  • Validating sham acupuncture methods is crucial for conducting rigorous double-blind trials.

Purpose of the Study:

  • To validate a newly developed sham acupuncture method for use in future double-blind clinical trials.
  • To assess the blinding success, penetration, pain, and deqi sensations of verum versus sham acupuncture.
  • To evaluate participant and practitioner blinding in a randomized, double-blind, parallel-group study.

Main Methods:

  • A randomized, double-blind, parallel-group trial involving 66 healthy participants.
  • Participants were assigned to verum (real) or sham acupuncture groups targeting LI4 and ST36.
  • Blinding was assessed using Bang's Blinding Index, alongside standardized questionnaires and the Numeric Rating Scale for sensations.

Main Results:

  • Participant blinding was successful at the ST36 acupuncture point.
  • Higher correct guesses for verum acupuncture at LI4 suggested a limitation in blinding efficacy.
  • Practitioners could not reliably distinguish between verum and sham acupuncture.
  • Verum acupuncture reported higher penetration and pain, with mixed deqi sensations; no adverse events occurred.

Conclusions:

  • The developed sham acupuncture shows potential for participant and practitioner blinding, particularly at ST36.
  • Challenges in blinding efficacy were noted at LI4, highlighting the need for further refinement.
  • Additional validation studies with larger samples, diverse acupuncture points, and specific populations are recommended.