Homotopic reduction in laser-evoked potential amplitude and laser-pain rating by abdominal acupuncture.

BACKGROUND: The neural mechanism underlying the analgesic effect of acupuncture is largely unknown. We aimed at investigating the effect of abdominal acupuncture (AA) on the laser-evoked potential (LEP) amplitude and laser-pain rating to stimulation of body parts either homotopic or heterotopic to the treated acupoint. METHODS: Laser-evoked potentials were recorded from 13 healthy subjects to stimulation of the right wrist (RW), left wrist (LW) and right foot (RF). LEPs were obtained before, during and after the AA stimulation of an abdominal area corresponding to the representation of the RW. Subjective laser-pain rating was collected after each LEP recording. RESULTS: The amplitude of the N2/P2 LEP component was significantly reduced during AA and 15 min after needle removal to both RW (F = 4.14, p = .02) and LW (F = 5.48, p = .008) stimulation, while the N2/P2 amplitude to RF stimulation (F = 0.94, p = .4) remained unchanged. Laser-pain rating was reduced during AA and 15 min after needle removal only to RW stimulation (F = 5.67, p = .007). CONCLUSION: Our findings showing an AA effect on LEP components to both the ipsilateral and contralateral region homotopic to the treated area, without any LEP change to stimulation of a heterotopic region, suggest that the AA analgesia is mediated by a segmental spinal mechanism. SIGNIFICANCE: Although abdominal acupuncture has demonstrated to be effective in the reduction in laser-evoked potential (LEP) amplitude and laser-pain rating, the exact mechanism of this analgesic effect is not known. In the current study, we found that treatment of an area in the "turtle representation" of the body led to a topographical pattern of LEP amplitude inhibition that can be mediated by a segmental spinal mechanism.

A multi-center international study of acupuncture for lateral elbow pain - Results of a randomized controlled trial.

BACKGROUND: Lateral elbow pain (LEP) due to tendinosis is one of the most common musculoskeletal pains of the upper limbs, yet there is no satisfactory treatment. This study was an international, prospective, multi-centre, randomized, controlled, clinical trial to evaluate the efficacy of acupuncture compared to sham laser in the treatment of LEP. METHODS: The study used a parallel and stratified design (1:1 allocation using a computer-generated sequence) and was participant-, outcome assessor- and statistician-blinded. Subjects from 18 to 80 years with unilateral chronic LEP (minimum three months) were recruited at four centres in Australia, China, Hong Kong and Italy. The treatment group received manual acupuncture at acupoints LI 10 and LI 11 on the affected side whereas the control group received sham laser acupuncture at the same acupoints. The primary endpoint was disabilities of the arm, shoulder, and hand (DASH) questionnaire score at the three-week post-treatment follow-up visit. Three VAS scales (pain at rest, pain on motion and pain during exertion) were secondary outcomes measures. Ninety-six subjects were allocated to either the treatment group (n = 47) or control group (n = 49) and were all included in the analysis. RESULTS: At the follow-up visit, we found significant differences in DASH score between the two groups (p = .015). The median change to baseline for the treatment group was -11.7 (interval: -50.83 to 23.33), and for the control group -7.50 (interval: -36.67 to 29.10). The estimated effect size was 0.47, indicating a medium effect. Significant differences were also found for secondary outcome measures for VAS of pain. There were no severe adverse events. Our findings suggest that acupuncture has a moderate efficacy in the treatment of LEP. CONCLUSIONS: Acupuncture was shown to be efficacious in improving the function of the arm associated with lateral elbow tendinosis. Both the DASH score and the pain VAS on two occasions (at rest and during motion) showed a significant change over time indicating acupuncture as a potential treatment for LEP due to tendinosis.

Acupuncture for Pain in Chronic Pancreatitis: A Single-Blinded Randomized Crossover Trial.

OBJECTIVES: Many patients with painful chronic pancreatitis (CP) have insufficient effect of treatment, and the prevalence of adverse effects is high. Consequently, alternatives to conventional management are needed. We aimed to study the effect of acupuncture in painful CP. METHODS: This was a prospective, single-blinded, randomized crossover trial. Fifteen patients with CP were assigned to a session of acupuncture followed by sham stimulation or vice versa. Patients rated clinical pain scores daily on a 0 to 10 visual analogue scale (VAS) and completed the Patient Global Impression of Change. For mechanistic linkage, resting state electroencephalograms were recorded and quantified by spectral power analysis to explore effects on central pain processing. RESULTS: Acupuncture, compared with sham stimulation, caused more pain relief (2.0 ± 1.5 VAS vs 0.7 ± 0.8 VAS; P = 0.009). The effect, however, was short, and after 1-week follow-up, there was no difference in clinical pain scores between groups (P = 1.0) or the rating of Patient Global Impression of Change (P = 0.8). Electroencephalogram spectral power distributions between sham and acupuncture were comparable between groups (all P > 0.6). CONCLUSIONS: The study presents proof-of-concept for the analgesic effect of acupuncture in pancreatic pain. Although the effect was short lasting, the framework may be used to conceptualize future trials of acupuncture in visceral pain.

Protocol for Acupuncture Treatment of Lateral Elbow Pain: A Multisite Randomised Controlled Trial in China, Hong Kong, Australia, and Italy.

Background. Lateral elbow pain is one of the most common musculoskeletal pains associated with the upper limb and has an estimated population incidence of 1-3%. Methods/Design. This study protocol is for a multisite randomised controlled study and is designed to evaluate the clinical efficacy of acupuncture in the treatment of chronic (over three months' duration) lateral elbow pain. Four study sites, in the People's Republic of China, Hong Kong, Italy, and Australia, will recruit 24 participants each. A total of 96 participants will be randomised to either an acupuncture group or a sham laser control group. The primary outcome measure will be the Disabilities of Arm, Shoulder, and Hand questionnaire with secondary outcome measures of Pain-Free Grip Strength Test, Muscle Tension Test, and a pain visual analogue scale. Discussion. Key features for conducting a multisite international acupuncture randomised clinical trial have been detailed in this protocol. Trial Registration. This trial is registered at Australian and New Zealand Clinical Trial Registry ACTRN12613001138774 on 11 October, 2013.

Effectiveness of an App for Reducing Preoperative Anxiety in Children: A Randomized Clinical Trial.

IMPORTANCE: Effective methods to reduce children's preoperative anxiety (such as giving information beforehand, organizing a tour of the operating room [OR] before the intervention, and incorporating clown physicians) may be difficult to implement for some hospitals, as they are time-consuming and expensive and require hospital staff to be performed. OBJECTIVE: To test the effectiveness of Clickamico, an app that shows clown physicians giving a comical and informative tour of the OR, for reducing preoperative anxiety in children. DESIGN, SETTING, AND PARTICIPANTS: This unblinded randomized clinical trial included 40 children aged 6 to 11 years undergoing a planned surgical intervention at a third-level Italian pediatric hospital from December 2013 to September 2014 randomized into experimental (n = 20) and control (n = 20) groups. INTERVENTIONS: The experimental intervention was a 6-minute video showing 2 clown physicians visiting the OR and explaining to each other what is in the OR in a joking way. The video was shown on a tablet to children in the experimental group the afternoon preceding a planned surgical procedure. The control intervention was the standard informative intervention regarding the surgical procedure the next day. MAIN OUTCOMES AND MEASURES: The main outcome was preoperative anxiety. Preoperative anxiety was measured before the experimental and control interventions and immediately before entering the OR using the modified Yale Preoperative Anxiety Scale (m-YPAS). RESULTS: The experimental and control groups were homogeneous with regard to age (mean [SD] age, 8.8 [2.5] vs 8.6 [2.2] years), sex (female, 11 [55.0%] vs 9 [45.0%]), parents' age (mean [SD] age, 41.8 [6.2] vs 41.3 [5.0] years), and previous surgical procedures (already underwent surgical procedure, 9 [45.0%] vs 10 [50.0%]). The initial mean (SD) m-YPAS scores were 37.3 (21.7) and 37.1 (13.8) for the experimental and control groups, respectively; the mean (SD) m-YPAS scores when entering the OR were 33.0 (18.4) and 48.6 (15.9), respectively (P = .009). The mean (SD) difference between the m-YPAS score at the first and second measurements of each participant was -2.8 (7.2) in the experimental group and 10.7 (10.8) in the control group. The 13.5-point difference between these averages was statistically significant (P = .003). CONCLUSIONS AND RELEVANCE: The app was effective in reducing preoperative anxiety in Italian children admitted to an Italian National Health System pediatric hospital and may act as a substitute for staff-provided interventions, allowing possible reductions of hospital costs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01688115.

Acupuncture Treatment of Lateral Elbow Pain: A Nonrandomized Pilot Study.

In planning for a large-scale multicenter trial to evaluate the effect of acupuncture for the treatment of lateral elbow pain, a pilot study was conducted. This was a prospective, investigator- and patient-blinded, nonrandomized, placebo controlled trial. Subjects were evaluated at baseline, before fourth, seventh, and ninth treatment, and at a two-week posttreatment follow-up. The treatment group received unilateral acupuncture at LI 10 and LI 11 at the affected side with manual needle manipulation; the control group received sham-laser acupuncture at the same acupoints. Measures included (i) disabilities of the arm, shoulder, and hand (DASH) questionnaire, (ii) pain-free grip strength (PFGS), and (iii) a visual analogue scale (VAS) for pain. Significant differences in DASH score, PFGS, and VAS between treatment and control group were found at the ninth treatment (n = 20 for each group, P < 0.05). Only DASH showed significant differences compared to the control for all the measurement time points after treatment commenced and appears to be a sensitive and appropriate primary outcome measure for the future multisite trial. Results from this pilot study provided relevant information about treatment efficacy, credibility of control treatment, and sensitivity of different outcome measures for the planning of the future trial.

A New Method for Sham-Controlled Acupuncture in Experimental Visceral Pain - a Randomized, Single-Blinded Study.

OBJECTIVE: Acupuncture is increasingly used as an alternative to medical therapy for various pain conditions. To study the effect of acupuncture in experimental and clinical studies, a control condition with sham acupuncture is needed. However, as such models have not been established in assessment of acupunctures effect against visceral pain, this study aimed to validate a new method for blinded sham acupuncture in experimental rectal pain. METHODS: Fifteen subjects underwent a sequence of either sham or real acupuncture in randomized order. In the sham arm, a hollow inner tube with a sharp tip was fitted into an outer tube and subjects were blinded to the stimulations. Before and after the intervention, pain was induced by rectal stimulation with an inflatable balloon distended until the subjects' pain threshold was reached. The resting electroencephalogram (EEG) was quantified by spectral power analysis to explore the central nervous system effects objectively. Additionally, after the second study day, the subject was asked to indicate the sequence of interventions. RESULTS: A significant increase in rectal balloon volume was observed after sham 12 ± 21 mL (P = 0.049) and acupuncture 17 ± 30 mL (P = 0.046). However, the change in volume was not different between groups (P = 0.6). No differences in EEG spectral power distributions between sham and acupuncture were seen (all P > 0.6). The correct sequence of sham and acupuncture was indicated by 36% of the subjects (P = 0.4). CONCLUSIONS: The presented sham procedure provides a valid method for blinding of "sham acupuncture" and may be used in future blinded controlled trials of acupuncture for visceral pain.

Effects of basic traditional Chinese diet on body mass index, lean body mass, and eating and hunger behaviours in overweight or obese individuals.

OBJECTIVE: To compare the effects of a basic traditional Chinese diet with a Western standard diet on body mass index (BMI), lean body mass (LBD), and eating and hunger behaviours. METHODS: A sample of 284 patients were randomized into 2 groups: group A (n = 142) followed a basic traditional Chinese diet (BCTD) and group B (n = 142) followed a Western standard diet (WSD). Both diets were set at approximately 1200 calories. The patients enrolled were compared before treatment and 6 weeks after treatment, and then follow-ups were made at 1 year and 5 years. RESULTS: In the BCTD group, BMI decreased by 0.46 kg/m2 and LBM by 0.25 kg, versus respectively 0.28 kg/m2 and 0.41 kg in the WSD group. Findings of eating self-assessment, hunger measurement and psychophysical indices of health were also in favour of the BCTD. CONCLUSION: Outcomes show that the BCTD has a better effect on BMI and LBM, as well as over the medium/long term, and provides stronger psychophysical support to obese patients.