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Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects.
Clin J Pain. 2006 May; 22(4):346-9.CJ

Abstract

OBJECTIVES

In recent years the retractable type of sham needle has been anticipated to be a possible solution for masking patients in acupuncture research. However, this needle has been intended mainly for acupuncture-naïve subjects. The authors' goal in this study was to assess the validity of the retractable type of sham needle.

METHODS

The authors conducted two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Different acupuncture points were used in each trial (a LI-4 trial and a BL-23 trial). The subjects received two sessions of different stimulations in each trial. A Park Sham Needle was used in one session, a genuine acupuncture needle in the other.

RESULTS

In the LI-4 trial, all of the 21 subjects (100%) felt penetration with the genuine needle, but only 7 of the 20 subjects (35%) felt a similar sensation with the sham needle (P=0.0002). Fifteen of the 21 subjects (71%) felt a dull sensation with the genuine needle, but only 4 of the 20 subjects (20%) felt a similar sensation with the sham needle (P=0.01). In the BL-23 trial, 14 of the 20 subjects (70%) felt penetration with the genuine needle and 10 of the 20 subjects (50%) felt "penetration" with the sham needle (P=0.39). Eight of the 20 subjects (40%) felt a dull sensation with the genuine needle and 2 of the 20 subjects (10%) did with the sham needle (P=0.109).

CONCLUSIONS

Potential factors that influence the applicability of "placebo" needling include not only inter-tester variability but also the patient's knowledge and experience of acupuncture, acupuncture point selection, the visual impact of needling, and so on.

Authors+Show Affiliations

Tsukayama H
Tsukuba College of Technology Clinic, Tsukuba City, Japan. tsukayama@k.tsukuba-tech.ac.jp
Yamashita H
No affiliation info available
Kimura T
No affiliation info available
Otsuki K
No affiliation info available

MeSH

Acupuncture TherapyAdultAgedCross-Over StudiesEquipment DesignFemaleHumansMaleMiddle AgedNeedlesOutcome Assessment, Health CarePain ManagementPain MeasurementPerceptionPlacebosReproducibility of ResultsSingle-Blind Method

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16691086

Citation

Tsukayama, Hiroshi, et al. "Factors That Influence the Applicability of Sham Needle in Acupuncture Trials: Two Randomized, Single-blind, Crossover Trials With Acupuncture-experienced Subjects." The Clinical Journal of Pain, vol. 22, no. 4, 2006, pp. 346-9.
Tsukayama H, Yamashita H, Kimura T, et al. Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Clin J Pain. 2006;22(4):346-9.
Tsukayama, H., Yamashita, H., Kimura, T., & Otsuki, K. (2006). Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. The Clinical Journal of Pain, 22(4), 346-9.
Tsukayama H, et al. Factors That Influence the Applicability of Sham Needle in Acupuncture Trials: Two Randomized, Single-blind, Crossover Trials With Acupuncture-experienced Subjects. Clin J Pain. 2006;22(4):346-9. PubMed PMID: 16691086.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects. AU - Tsukayama,Hiroshi, AU - Yamashita,Hitoshi, AU - Kimura,Tomoaki, AU - Otsuki,Kuniharu, PY - 2006/5/13/pubmed PY - 2006/7/14/medline PY - 2006/5/13/entrez SP - 346 EP - 9 JF - The Clinical journal of pain JO - Clin J Pain VL - 22 IS - 4 N2 - OBJECTIVES: In recent years the retractable type of sham needle has been anticipated to be a possible solution for masking patients in acupuncture research. However, this needle has been intended mainly for acupuncture-naïve subjects. The authors' goal in this study was to assess the validity of the retractable type of sham needle. METHODS: The authors conducted two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Different acupuncture points were used in each trial (a LI-4 trial and a BL-23 trial). The subjects received two sessions of different stimulations in each trial. A Park Sham Needle was used in one session, a genuine acupuncture needle in the other. RESULTS: In the LI-4 trial, all of the 21 subjects (100%) felt penetration with the genuine needle, but only 7 of the 20 subjects (35%) felt a similar sensation with the sham needle (P=0.0002). Fifteen of the 21 subjects (71%) felt a dull sensation with the genuine needle, but only 4 of the 20 subjects (20%) felt a similar sensation with the sham needle (P=0.01). In the BL-23 trial, 14 of the 20 subjects (70%) felt penetration with the genuine needle and 10 of the 20 subjects (50%) felt "penetration" with the sham needle (P=0.39). Eight of the 20 subjects (40%) felt a dull sensation with the genuine needle and 2 of the 20 subjects (10%) did with the sham needle (P=0.109). CONCLUSIONS: Potential factors that influence the applicability of "placebo" needling include not only inter-tester variability but also the patient's knowledge and experience of acupuncture, acupuncture point selection, the visual impact of needling, and so on. SN - 0749-8047 UR - https://www.unboundmedicine.com/medline/citation/16691086/Factors_that_influence_the_applicability_of_sham_needle_in_acupuncture_trials:_two_randomized_single_blind_crossover_trials_with_acupuncture_experienced_subjects_ DB - PRIME DP - Unbound Medicine ER -