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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., (© 2020 European Pain Federation - EFIC®.)

Acupuncture has been broadly applied in the management of many diseases and conditions; however, its mechanism of action has been partially elucidated. Additionally, assessment of psychophysical responses in the acupuncture therapy is not common regarding anxiety disorder studies. Taken together, the therapeutic effect of acupuncture appears when De Qi psychophysical response is experienced following stimulation of the afferent sensory nerves. The present study investigates the level of anxiety perceived at different occasions in acupuncture and mock laser group. Furthermore, it examines the relationship between perceived De Qi psychophysical response and the level of anxiety experienced during administration of each intervention. The study was embedded in a two-arm parallel design multi-center, randomized clinical trial, the Tennis Elbow Acupuncture-International Study-China, Hong Kong, Australia, Italy. Participants' level of anxiety was measured using a validated instrument, the Massachusetts General Hospital Acupuncture Sensation Mood Scale. Ninety-six participants with Lateral Elbow Pain were randomly allocated into two groups; the acupuncture treatment group (n = 47) and the inactive mock laser control group (n = 49). Data were collected immediately following the interventions at the first and the ninth session within the clinical trial. Acupuncture with De Qi did not induce higher level of anxiety compared to prior administration of acupuncture. In fact, participants were more relaxed after receiving acupuncture than those who received mock laser. There was also a weak association between participants' perception of anxiety during acupuncture and the MASS De Qi Index in session nine only (p < 0.01). Further investigation of the result revealed weak positive correlation between anxiety perceived during administration of acupuncture and the following De Qi characteristics; 'soreness' (p < 0.01), 'Deep pressure' (p < 0.05), 'Heaviness' (p < 0.05), and 'Fullness/distension' (p < 0.05). Acupuncture can be regarded as a potential therapy for preoperative anxiety through its possible regulatory function of emotion. While culture may not alter the expectation of the individual regarding anxiety, symptomology associated with anxiety should be understood within the context of the cultural background., (Copyright © 2018. Published by Elsevier Ltd.)

Background: Similar to De Qi psychophysical responses, propagated sensation along the channels (PSC) is considered an important phenomenon in traditional Chinese acupuncture. In acupuncture clinical trials, different acupuncture manipulation techniques are used to enhance the propagation of sensation along the channels to facilitate an optimum therapeutic result., Aim: To examine and compare the PSC reported by participants in a clinical trial following the administration of acupuncture and inactive mock laser., Methods: The study was embedded in a two-arm parallel design multicenter, randomized clinical trial, the Tennis Elbow Acupuncture-International Study-China, Hong Kong, Australia, Italy (TEA IS CHAI). Needle sensations were measured using a validated instrument, the Massachusetts General Hospital Acupuncture Sensation Spreading Scale. Ninety-six participants with lateral elbow pain were randomly allocated into two groups in a 1:1 ratio; the acupuncture treatment group (n = 47) and the mock laser control group (n = 49). Participants in both groups received the intervention at two acupoints, LI10 and LI11, consisting of 2 minutes of either standardized needle manipulation or mock laser at each acupoint with a rest period between each intervention period. Data were collected immediately following the interventions at the first and the ninth session within the clinical trial., Results: Although participants in both groups perceived PSC radiating to similar sites along the upper limb, the frequency of the reported radiation sites among the two intervention groups for both radiation up the limb (p < 0.05) and radiation down the limb (p < 0.001) were statistically significantly different. Among the radiating sensation sites recorded within the two study groups, the sensations were reported as radiating a greater distance down the forearm to the wrist compared to up the arm. Evaluation of PSC across the four study sites revealed a statistically significant difference in frequency of the reported radiation down the limb sites in each study group and radiation up the limb sites only in control group only (p < 0.001)., Conclusion: The findings of the study demonstrated that the PSC phenomenon is not just associated with needling but can be perceived when using a mock laser., Trial Registration: Australian and New Zealand Clinical Trial Registry reference: ACTRN12613001138774 on 11th of October 2013., (Copyright © 2017. Published by Elsevier B.V.)

Background: The psychophysical responses induced by verum acupuncture are characterized by a constellation of unique subjective sensory responses commonly termed De Qi. Furthermore, a variety of sham interventions have been used as a control for acupuncture clinical trials. Indeed, one such control has been mock laser which has been used as control intervention in several acupuncture clinical controlled trials. The current study aim was to examine the De Qi sensory responses and its related characteristics elicited from acupuncture and compare them to those reported following sham laser in participants enrolled in a clinical trial., Methods: The study was embedded in a multi-center, two-arm randomised clinical trial, which evaluated the effect of acupuncture on lateral elbow pain. De Qi was assessed using the Massachusetts General Hospital Acupuncture Sensation Scale (MASS). Ninety-six participants were randomly allocated to receive either acupuncture (n = 47) or mock laser (n = 49) at the acupoints LI 10 and LI 11., Results: Participants in both intervention groups reported similar De Qi psychophysical characteristics; however, both intensity and frequency of the individually perceived De Qi characteristics were significantly higher in the acupuncture group. 'Soreness', 'deep pressure', and 'fullness-distension' in the acupuncture group and 'tingling', and 'sharp pain' in mock laser group, were identified as the leading characteristics. Similar level of MASS De Qi Index (MDI) scores were reported for 'Hong Kong-China' and 'Australia-Italy' with a significantly higher level of De Qi reported by 'Hong Kong-China'. Furthermore, two distinct De Qi categories were identified, namely De Qi (in line with classical sensory responses of Suan, Ma, Zhang, and Zhong) and pain., Conclusions: Subjective 'somatic or interoceptive awareness' should be taken into account when De Qi psychophysical responses are examined. The study accentuates the necessity and the significance of further research into interoception phenomenon which may contribute to a better understanding of the placebo effect and De Qi psychophysical responses., Trial Registration: Australian and New Zealand Clinical Trial Registry reference: ACTRN12613001138774 on 11th of October 2013.

Purpose: Controlling cancer-related pain is an important component in the palliative care of cancer patients. The objective of this review was to assess the effectiveness of acupuncture for treating cancer pain., Methods: Fourteen databases were searched from their inception through April 2011. Randomised clinical trials (RCTs) were included if acupuncture was used as the sole treatment or as a part of a combination therapy for cancer pain. Studies were included if they were controlled with a placebo or controlled against a drug-therapy or no-treatment group. The Cochrane criteria were used to assess the risk of bias., Results: A total of 15 RCTs met our inclusion criteria. All of the included RCTs were associated with a high risk of bias. The majority of acupuncture treatments or combination therapies with analgesics exhibited favourable effects compared with conventional treatments in individual studies. However, a meta-analysis suggested that acupuncture did not generate a better effect than drug therapy (n = 886; risk ratio (RR), 1.12; 95% CI 0.98 to 1.28; P = 0.09). The comparison between acupuncture plus drug therapy and drug therapy alone demonstrated a significant difference in favour of the combination therapy (n = 437; RR, 1.36; 95% CI 1.13 to 1.64; P = 0.003). The results of this systematic review provide no strong evidence for the effectiveness of acupuncture in the management of cancer pain., Conclusion: The total number of RCTs included in the analysis and their methodological quality were too low to draw firm conclusions. Future rigorous RCTs will be necessary to assess the clinical efficacy of acupuncture in this area.

Background: Quality acupuncture influences the outcomes of clinical research, and issues associated with effective administration of acupuncture in randomized controlled trials need to be addressed when appraising studies., Objective: The study objective was to achieve consensus on domains and items for inclusion in a rating scale to assess quality acupuncture administered in clinical research., Study Design and Subjects: An active group of Australian acupuncture researchers initially identified a pool of items assessing quality. The Delphi consensus process was then used to select and reduce the number of items, and an additional expert panel of 42 researchers were invited to participate. Participants initially ranked items along a five-point scale for the first Delphi round, and indicated an agree or disagree response during the second round. For an item to be retained into the second round, an item had to attain greater than 80% agreement that the item described a dimension of quality acupuncture and related study design., Results: Thirty-two (32) experts agreed to participate in the study. After two rounds of the Delphi process, consensus was reached on 14 domains and 26 items relating to quality acupuncture. Domains, items, and minimum standards related to study design; rationale of the intervention; criteria relating to needling stimulation either manual or electrostimulation; duration and frequency of treatment; and practitioner training., Conclusions: Items for inclusion in an instrument to assess quality acupuncture in clinical research were identified. Further development of the instrument including relative weighting of items and reliability testing is under way.

Introduction: Traditional Chinese Medicine (TCM), a modern interpretation of Chinese medicine, developed in the 1950s. It differentiates biomedical diseases into patterns. Each pattern comprises symptom/signs that have their own unique treatment protocol. Most TCM research has used fixed formula treatments for Western-defined diseases with outcomes often measured using objective biomedical markers. More recently, a number of trials have attempted to accommodate TCM clinical practice within the framework of rigorous evidence-based medical research. The aim of this article is to describe a novel outcome measure based on TCM patterns that was used in a pilot study for people with hepatitis C virus (HCV)., Methods: Sixteen (16) participants with HCV were enrolled in a randomized, controlled pilot study and allocated to a treatment or control group. TCM pattern diagnosis was obtained at baseline and used to guide acupuncture treatment for the treatment group. Each individual's primary, secondary, and tertiary TCM patterns were identified, which involved the systematic evaluation of the participant's information against the TCM patterns and conversion of the pattern to a percentage. Baseline and postintervention percentages for the three TCM patterns for the two groups were compared to assess change., Results: There was a significant mean percentage decrease in pattern expression at week 12 compared to baseline for the secondary and tertiary patterns of the treatment group (56.3% versus 47.5%; p = 0.045 and 48.1% versus 33.6%; p = 0.037, respectively). No significant change was found for the primary, secondary, or tertiary patterns for the control group or for the primary pattern associated with the treatment group., Conclusions: The quantification of TCM patterns in this study permitted statistical evaluation of TCM pattern change. Previously, TCM pattern identification had only been used as a basis for developing the treatment protocol in clinical trials. This is the first time it has been employed as a novel outcome measure.