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.

Anxiety related to De Qi psychophysical responses as measured by MASS: A sub-study embedded in a multisite randomised clinical trial.

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.

Investigation of the Phenomenon of Propagated Sensation along the Channels in the Upper Limb Following Administration of Acupuncture and Mock Laser.

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.

Psychophysical responses in patients receiving a mock laser within context of an acupuncture clinical trial: an interoceptive perspective.

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.

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.

Pattern Differentiation of Lateral Elbow Pain in Traditional Chinese Medicine: A Systematic Review.

BACKGROUND: Traditional Chinese Medicine (TCM) uses a sophisticated diagnostic system called pattern differentiation, which allows for the tailor-made treatment of individuals. OBJECTIVE: This study aimed to identify the commonly used TCM patterns for lateral elbow pain (LEP), as well as the clinical features associated with these patterns. METHOD: Journal literature in 15 major Chinese and English databases and textbooks from five medical libraries as well as Chinamaxx were reviewed. RESULTS: Five hundred and fifty-five full-text journal articles, as well as 465 textbooks, were retrieved for further assessment, but only eight studies and seven books that mentioned LEP patterns could be identified and included in this study. The top four patterns that were identified were the wind-cold-dampness pattern, the qi stagnation and blood stasis pattern, the dual deficiency of qi and blood pattern, and the retained dampness-heat pattern, each of which was associated with unique features that were made up of distinct signs and symptoms. CONCLUSIONS: The unique features identified for each of the major patterns might be the key to understanding TCM individualized treatment based on pattern differentiation. Furthermore, the approach taken in studying TCM pattern of LEP may also be useful for studying the TCM patterns of other musculoskeletal conditions.

TCM Pattern Questionnaire for Lateral Elbow Pain: Development of an Instrument via a Delphi Process.

Individualized acupuncture treatment has been practiced for pain therapy. This study used acupuncture treatment for lateral elbow pain (LEP) as an example to study the diagnostic practice of individualized acupuncture treatment. A provisional version of LEP pattern questionnaire was developed based on a recent systematic review on TCM pattern diagnosis for LEP. A Delphi panel of 33 clinical experts from seven different countries was formed, and the Delphi survey was conducted in Chinese and English language for two rounds. Consensus was achieved from all 26 panelists who responded to the second round on 243 items of the instrument, which included a 72-question-long questionnaire. The mean level of expert consensus on the items of the final questionnaire was 85%. Consensus was found on four TCM patterns that could underlie LEP, namely, the wind-cold-dampness pattern, the qi stagnation and blood stasis pattern, the dual deficiency of qi and blood pattern, and the retained dampness-heat pattern. A list of signs and symptoms indicating one of the four TCM patterns and a list of preferred treatment modalities for each pattern were also generated. Our instrument shows considerable content validity. Further validity and reliability studies are under way.

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.

Acupuncture and moxibustion for lateral elbow pain: a systematic review of randomized controlled trials.

BACKGROUND: Acupuncture and moxibustion have widely been used to treat lateral elbow pain (LEP). A comprehensive systematic review of randomized controlled trials (RCTs) including both English and Chinese databases was conducted to assess the efficacy of acupuncture and moxibustion in the treatment of LEP. METHODS: Revised STRICTA (2010) criteria were used to appraise the acupuncture procedures, the Cochrane risk of bias tool was used to assess the methodological quality of the studies. A total of 19 RCTs that compared acupuncture and/or moxibustion with sham acupuncture, another form of acupuncture, or conventional treatment were included. RESULTS: All studies had at least one domain rated as high risk or uncertain risk of bias in the Cochrane risk of bias tool. Results from three RCTs of moderate quality showed that acupuncture was more effective than sham acupuncture. Results from 10 RCTs of mostly low quality showed that acupuncture or moxibustion was superior or equal to conventional treatment, such as local anesthetic injection, local steroid injection, non-steroidal anti- inflammatory drugs, or ultrasound. There were six low quality RCTs that compared acupuncture and moxibustion combined with manual acupuncture alone, and all showed that acupuncture and moxibustion combined was superior to manual acupuncture alone. CONCLUSION: Moderate quality studies suggest that acupuncture is more effective than sham acupuncture. Interpretations of findings regarding acupuncture vs. conventional treatment, and acupuncture and moxibustion combined vs. manual acupuncture alone are limited by the methodological qualities of these studies. Future studies with improved methodological design are warranted to confirm the efficacy of acupuncture and moxibustion for LEP.