Although acupuncture is listed as a beneficial treatment for neck/shoulder stiffness, which has increased with the spread of information technology, to date, evidence of its efficacy under double-blind conditions has not been shown. This study aimed to assess whether acupuncture treatment with superficial skin piercing is superior to placebo treatment. A randomized, double-blind (practitioner-patient) placebo-controlled trial was performed at a single center with four arms (ISRCTN76896018).
View Article and Find Full Text PDFThe Patient State Index (PSI) is the numerical value of anesthesia depth as measured using a SedLine Sedation Monitor (Masimo Corporation). In this pilot study, we evaluated PSI values captured during intravenous (IV) moderate sedation for dental treatment. During the dental treatment, a dental anesthesiologist maintained the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score at 3 to 4 by adjusting the administration of midazolam and propofol while PSI values were recorded.
View Article and Find Full Text PDFAltern Ther Health Med
September 2021
Context: It's difficult to conduct experiments using a double-blind design in controlled clinical trials of acupuncture. To resolve this problem with blinding, we designed double-blind needles (DBNs) with stuffing to mimic the resistance felt during insertion of a regular acupuncture needle. Results of the past studies using 0.
View Article and Find Full Text PDFObjective: To investigate the influence of the depth of skin press in blunt tip placebo acupuncture needles on patient blinding and its relationship to needle diameter.
Methods: Forty healthy volunteers were enrolled as subjects for patient blinding. Four acupuncturists applied the following needles randomly at three points in each forearm: 0.
Evid Based Complement Alternat Med
June 2015
It remains an open question whether placebo/sham acupuncture, in which the needle tip presses the skin, can be used as a placebo device for research on pain. We compare the analgesic effect of the skin-touch placebo needle with that of the no-touch placebo needle, in which the needle tip does not touch the skin, in a double-blind crossover manner including no-treatment control in 23 healthy volunteers. The subjects received painful electrical stimulation in the forearm before and during needle retention to the LI 4 acupoint and after the removal of the needle and rated pain intensity using a visual analogue scale.
View Article and Find Full Text PDFBlinding protects against bias but the success of blinding is seldom assessed and reported in clinical trials including studies of acupuncture where blinding represents a major challenge. Recently, needles with the potential for double-blinding were developed, so we tested if acupuncture can be double-blinded in a randomized study of sixty-seven patients with acute pain ≥ 3 (0-10 scale following third molar removal) who received active acupuncture with a penetrating needle or placebo acupuncture with a non-penetrating needle. To test if acupuncture was administered double-blind, patients and acupuncturists were asked about perceived treatment allocation at the end of the study.
View Article and Find Full Text PDFBackground: Whether acupuncture treatment employing multiple penetrating, skin-touch placebo, or no-touch placebo needles designed for double blinding actually do blind practitioners and patients has not been investigated. We aimed to investigate this question.
Subjects: 120 patients with functional neck/shoulder stiffness but in otherwise healthy condition were randomly assigned to a treatment using four penetrating, four skin-touch placebo, or four no-touch placebo needles.
Background: Functional neck/shoulder stiffness is one of the most well-known indications for acupuncture treatment in Japan. There is little evidence for the effectiveness of acupuncture treatment for functional neck/shoulder stiffness. Research using two different placebos may allow an efficient method to tease apart the components of real acupuncture from various kinds of 'non-specific' effects such as ritual with touch or ritual alone.
View Article and Find Full Text PDFBackground: Vibration-induced finger flexion reflex (VFR) is inhibited with acupuncture to TE 5 or LI 4 at the skin innervated by the radial nerve.
Objective: The aim of this study was to determine if acupoints in regions innervated by the radial nerve are specific to inhibit VFR.
Materials And Methods: This experiment was performed using a crossover design with 3 acupuncture groups (needle insertion to the right LU 11, PC 9, or SI 1) and a control group (no needle treatment).
Background: Most of our knowledge about similarities in the neural processing of painful and pleasant sensations in the brain derives from studying each phenomenon separately. Patients often feel pain induced by acupuncture, which is noxious stimulation having the symbolic message of the cure, as pleasant.
Objectives: We investigated whether the double-blind acupuncture needles are potential tool to investigate coinciding pain and pleasant events.
No previous report has described whether information regarding an odor used in aromatherapy has placebo effects. We investigated whether placebo analgesia was engendered by verbal information regarding the analgesic effects of an odor. Twelve of 24 subjects were provided with the information that a lavender odor would reduce pain (informed), whereas the other 12 subjects were not (not-informed).
View Article and Find Full Text PDFObjectives: This study investigated the effect of acupuncture needles developed for double-blind (practitioner-patient blinding) trials employing a tapping-in method that is commonly used to penetrate the skin in Japanese-style acupuncture. DESIGN, SUBJECTS, AND INTERVENTIONS: An acupuncturist applied a penetrating, a skin-touch placebo, and a no-touch control needle designed to blind both practitioners and patients in the forearm in 80 healthy subjects (patients) by tapping-in method.
Setting: The setting was a practice room of the Japan School of Acupuncture, Moxibustion and Physiotherapy, Tokyo, Japan.
Background: A no-touch control needle in which the needle tip cannot reach the skin has been designed, and has been validated for practitioner blinding in a previous study but not for participant blinding.
Objective: To test whether the no-touch control needle can effectively blind subjects.
Methods: An acupuncturist applied, in turn, a no-touch control, skin-touch placebo and penetrating needle in one forearm of 80 healthy subjects.
Background: The masking properties of a new, non-penetrating, double-blind placebo acupuncture needle were demonstrated. Practitioners correctly identified some of the needles; if they were confident in this opinion, they would be unblinded.
Objective: To investigate the clues that led to correct identification, and the confidence in this decision.
Background: Vibration-induced finger flexion reflex (VFR) in the upper extremity is inhibited by needle insertion acupuncture to the large intestine 4 (LI4) at the hand. This claim has a limitation because the inhibitory effect is deduced only from reduction in the maximum finger flexion (FF) force during the tonic flexion reflex by vibratory stimulation after acupuncture.
Methods: The study was a crossover design with two conditions-acupuncture and control-to which 16 healthy volunteers were subjected.
It is reasonable to hypothesize that dipoles estimated from grand averaged event-related potentials based on summed-up data obtained from multiple subjects and standard head models could correspond to typical brain regions associated to a particular event. Six healthy subjects were enrolled in a study to test this hypothesis. We estimated dipoles from somatosensory-evoked potentials (SEP) elicited by electrical stimulation to the left median nerve.
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