Developing and Validating a Sham Acupuncture Needle CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials. Estimates of quality and reliability with the physiotherapy evidence-based database scale to assess the methodology of randomized controlled trials of pharmacological and nonpharmacological interventions. Evidence Based Complementary and Alternative Medicine Do certain countries produce only positive results? A systematic review of controlled trials. Reported quality of randomized controlled trials in neglect rehabilitation Acupuncture for chronic shoulder pain in persons with spinal cord injury: a small-scale clinical trial. A therapeutic trial of acupuncture in neurogenic bladder of spinal cord injured patients – a preliminary report Reliability of the PEDro scale for rating quality of randomized controlled trials. Review of randomised controlled trials of traditional Chinese medicine Clinical Trial of Acupuncture for Patients with Spinal Cord Injuries Acupuncture and Trager psychophysical integration in the treatment of wheelchair user's shoulder pain in individuals with spinal cord injury. [Observation on therapeutic effect of electroacupuncture at points Baliao and Huiyang (BL 35) on retention of urine induced by spinal cord injury]. [Acupuncture for the lower extremity spasm induced by spinal injury: random controlled trial of single case]. [Clinical research of electroacupuncture combined with acupoint-injection of botulinum toxin A in treating the muscle spasticity by spinal cord injury].
Objectives To develop a sham needle device and test its credibility as a control for acupuncture when used in a r and omised controlled trial of myofascial trigger point needling in patients with whiplash associated pain . Methods Sham needles were developed by blunting true acupuncture needles . Whiplash injured patients ( < 16 weeks duration ) were r and omly allocated to receive either true acupuncture or the “ placebo ” sham needle control . The true and sham needling interventions were delivered using the same st and ardised procedure . Patients were informed that they would receive either real or placebo needles , and asked ( i ) to state which treatment they believed they had received ( treatment belief ) ; ( ii ) to complete the four item Borkovec and Nau self- assessment credibility scale . Results were compared between groups and the analysis explored whether a patient 's previous experience of acupuncture was related to their treatment belief . Other outcomes of the study will be reported elsewhere . Results 20 patients received the true acupuncture and 21 received the sham . There was no significant difference between the treatment beliefs of the two groups ( χ 2 = 1.51 ; p>0.2 ) nor in the mean item scores on the Borkovec and Nau credibility scale ( t test , p values ranged from 0.38 to 0.87 ) . Of the patients in the sham acupuncture group who had previous experience of acupuncture , none recorded receiving the sham intervention . Conclusion Within the context of this pilot study , the sham acupuncture intervention was found to be a credible control for acupuncture . This supports its use in a planned , definitive , r and omised controlled trial on a similar whiplash injured population Overwhelming evidence shows the quality of reporting of r and omised controlled trials ( RCTs ) is not optimal . Without transparent reporting , readers can not judge the reliability and validity of trial findings nor extract information for systematic review s. Recent method ological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects . Such systematic error is seriously damaging to RCTs , which are considered the gold st and ard for evaluating interventions because of their ability to minimise or avoid bias . A group of scientists and editors developed the CONSORT ( Consoli date d St and ards of Reporting Trials ) statement to improve the quality of reporting of RCTs . It was first published in 1996 and up date d in 2001 . The statement consists of a checklist and flow diagram that authors can use for reporting an RCT . Many leading medical journals and major international editorial groups have endorsed the CONSORT statement . The statement facilitates critical appraisal and interpretation of RCTs . During the 2001 CONSORT revision , it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports . A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement . After an expert meeting in January 2007 , the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement . This up date improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition , such as selective outcome reporting bias . This explanatory and elaboration document-intended to enhance the use , underst and ing , and dissemination of the CONSORT statement-has also been extensively revised . It presents the meaning and rationale for each new and up date d checklist item providing examples of good reporting and , where possible , references to relevant empirical studies . Several examples of flow diagrams are included . The CONSORT 2010 Statement , this revised explanatory and elaboration document , and the associated website ( www.consort-statement.org ) should be helpful re sources to improve reporting of r and omised trials BACKGROUND AND PURPOSE Systematic review s and meta-analyses often include an evaluation of the method ological quality of the individual studies that have been included , and are usually conducted by at least 2 individuals . The objective of this study was to assess the method ological quality and reliability of a series of r and omized controlled trials ( RCTs ) of both pharmacological and nonpharmacological interventions by use of the 10-item Physiotherapy Evidence -Based Data base ( PEDro ) Scale . METHODS Two abstract ors independently review ed 81 RCTs assessing a variety of interventions . The Cohen kappa statistic and the intraclass correlation coefficient ( ICC ) were used to assess agreement between abstract ors . RESULTS The average total PEDro scores were 5.94 ( SD=1.43 ) for all studies combined , 6.88 ( SD=1.2 ) for pharmacological studies , and 5.29 ( SD=1.26 ) for nonpharmacological studies . The median score for pharmacological studies was significantly higher than that for nonpharmacological studies ( 7 versus 5 ) . Pair-wise kappa scores ranged from a low of .452 for concealed allocation among drug trials to perfect agreement ( 1.00 ) for r and omization and reporting of results from between-group comparisons . The ICCs associated with the cumulative PEDro score were .91 ( 95 % confidence interval [CI]=.83-.94 ) for all studies , .89 ( 95 % CI=.78-.95 ) for pharmacological studies , and .91 ( 95 % CI=.84-.952 ) for nonpharmacological studies . DISCUSSION AND CONCLUSION The method ological quality for pharmacological interventions was significantly higher than that for nonpharmacological interventions . There was good agreement between raters at an individual item level and in total PEDro scores . A lack of reporting clarity , poor organization of the report , or the failure to include salient details contributed to less-than-perfect agreement between raters The existing review s of massage therapy ( MT ) research are either limited to infants , adults , or were conducted prior to the publication of the most recent studies using pediatric sample s. R and omized controlled trials ( RCTs ) of pediatric MT are review ed . A literature search yielded 24 RCTs of pediatric MT  , defined as the manual manipulation of soft tissue intended to promote health and well-being in recipients between 2 and 19 years of age . Because RCTs of pediatric MT varied considerably in the amount and types of data reported , quantitative and narrative review methods were both used . Singledose and multiple-dose effects were examined separately . Among single-dose effects , significant reductions of state anxiety were observed at the first session ( g 1⁄4 0.59 , P < 0.05 ) and the last session ( g 1⁄4 1.10 , P < 0.01 ) of a course of treatment . Effects for salivary cortisol ( g 1⁄4 0.28 ) , negative mood ( g 1⁄4 0.52 ) and behavior ( g 1⁄4 0.37 ) were non-significant . Three of eleven multiple-dose effects were statistically significant . These were trait anxiety ( g 1⁄4 0.94 , P < 0.05 ) , muscle tone ( g 1⁄4 0.90 , P < 0.01 ) and arthritis pain ( g1⁄4 1.33 , P < 0.01 ) . Results of studies not permitting effect size calculation were judged to be generally consistent with quantitative results . MT benefits pediatric recipients , though not as universally as sometimes reported . Numerous weaknesses endemic to MT research ( e.g. low statistical power , frequent failure to report basic descriptive statistics ) are identified , and recommendations for future pediatric MT research are discussed OBJECTIVE To determine whether clinical trials originating in certain countries always have positive results . DATA SOURCES Abstract s of trials from Medline ( January 1966-June 1995 ) . STUDY SELECTION Two separate studies were conducted . The first included trials in which the clinical outcome of a group of subjects receiving acupuncture  was compared to that of a group receiving placebo , no treatment , or a nonacupuncture intervention . In the second study , r and omized or controlled trials of interventions other than  acupuncture  that were published in China , Japan , Russia/USSR , or Taiwan were compared to those published in Engl and . DATA EXTRACTION Blinded review ers determined inclusion and outcome and separately classified each trial by country of origin . DATA SYNTHESIS In the study of acupuncture  trials , 252 of 1085 abstract s met the inclusion criteria . Research conducted in certain countries was uniformly favorable to acupuncture ; all trials originating in China , Japan , Hong Kong , and Taiwan were positive , as were 10 out of 11 of those published in Russia/USSR . In studies that examined interventions other than acupuncture , 405 of 1100 abstract s met the inclusion criteria . Of trials published in Engl and , 75 % gave the test treatment as superior to control . The results for China , Japan , Russia/USSR , and Taiwan were 99 % , 89 % , 97 % , and 95 % , respectively . No trial published in China or Russia/USSR found a test treatment to be ineffective . CONCLUSIONS Some countries publish unusually high proportions of positive results . Publication bias is a possible explanation . Research ers undertaking systematic review s should consider carefully how to manage data from these countries The aim of this study is to assess the reported quality of r and omized controlled trials ( RCTs ) on the effectiveness of neglect rehabilitation using a st and ardized scale . A search of seven electronic data bases was carried out . Selected articles were scored using the PEDro scale and classified as high or low quality study both with the original cut off of 6 and a modified cut off of 5 . A linear regression analysis between year of publication and quality rate was used to test whether the quality of the studies improved with time . A total of 18 RCTs were selected . Six articles ( 33.3 % ) and 10 articles ( 55.56 % ) were classified as having high quality when the original cut off or the modified cut off of the PEDro scale were used , respectively . Analysis shows no time-related changes in PEDro scores . The results show that reported quality is moderate for RCTs in neglect rehabilitation OBJECTIVE To determine the efficacy of acupuncture in the treatment of chronic musculoskeletal shoulder pain in subjects with spinal cord injury ( SCI ) . DESIGN R and omized , double blind ( participants , evaluator ) , placebo ( invasive sham ) controlled trial . SETTING Clinical research center . PARTICIPANTS Seventeen manual wheelchair-using subjects with chronic SCI and chronic musculoskeletal shoulder pain . INTERVENTIONS Participants were r and omly assigned to receive 10 treatments of either acupuncture or invasive sham acupuncture ( light needling of nonacupuncture points ) . MAIN OUTCOME MEASURE Changes in shoulder pain intensity were measured using the Wheelchair User 's Shoulder Pain Index . RESULTS Shoulder pain decreased significantly over time in both the acupuncture and the sham acupuncture groups ( P=.005 ) , with decreases of 66 % and 43 % , respectively . There was no significant difference between the 2 groups ( P=.364 ) . There was , however , a medium effect size associated with the acupuncture treatment . CONCLUSIONS There appears to be an analgesic effect or a powerful placebo effect associated with both acupuncture and sham acupuncture . There was a medium treatment effect associated with the acupuncture , which suggests that it may be superior to sham acupuncture . This observation , along with the limited power , indicates that a larger , more definitive r and omized controlled trial using a similar design is warranted Eighty patients with spinal cord injury ( SCI ) and neurogenic bladder were studied . Among them , 28 ( 70 % ) cases in the control group and 32 ( 80 % ) cases in the electroacupuncture group achieved ultimately balanced voiding and were selected for further analysis . The acupuncture group received electroacupuncture at four acupoints : Chung Chi ( Conception Vessel CV3 ) , Kuan Yuan ( CV4 ) , and bilateral Tzu Liao ( Urinary Bladder UB32 ) , in addition to conventional intermittent catheterization program ( ICP ) . Whereas the control group underwent conventional bladder training program with ICP only . The results revealed that the time of achieving balanced voiding was statistically significantly shorter with electroacupuncture than in the control group : 57.1±22.5 vs 85.2±27.4 days ( P<0.005 ) for upper motor neuron lesions , and 55.4±22.6 vs 83.4±26.1 days ( P<0.01 ) for lower motor neuron lesions . However , there was almost no difference between upper motor neuron lesions and lower motor neuron lesions . When acupuncture commenced was also a factor to influence the results . Those who received acupuncture within 3 weeks after injury had significantly shortened the total days to achieve a balanced bladder , as compared to those who received acupuncture 3 weeks after injury ( 46.6±13.2 vs 65.8±15.4 days , P<0.005 ) . Our study implied that acupuncture might be beneficial in the management of neurogenic bladder of SCI , and the earlier the patient received electro-acupuncture therapy , the sooner the bladder balanced . On the other h and , we also found that complete spinal cord injury , either with pronounced detrusor-sphincter dyssynergia in upper motor nueron lesion or with persistent areflexic bladder in lower motor neuron lesion , was not affected by acupuncture BACKGROUND AND PURPOSE Assessment of the quality of r and omized controlled trials ( RCTs ) is common practice in systematic review s. However , the reliability of data obtained with most quality assessment scales has not been established . This report describes 2 studies design ed to investigate the reliability of data obtained with the Physiotherapy Evidence Data base ( PEDro ) scale developed to rate the quality of RCTs evaluating physical therapist interventions . METHOD In the first study , 11 raters independently rated 25 RCTs r and omly selected from the PEDro data base . In the second study , 2 raters rated 120 RCTs r and omly selected from the PEDro data base , and disagreements were resolved by a third rater ; this generated a set of individual rater and consensus ratings . The process was repeated by independent raters to create a second set of individual and consensus ratings . Reliability of ratings of PEDro scale items was calculated using multirater kappas , and reliability of the total ( summed ) score was calculated using intraclass correlation coefficients ( ICC [ 1,1 ] ) . RESULTS The kappa value for each of the 11 items ranged from.36 to.80 for individual assessors and from.50 to.79 for consensus ratings generated by groups of 2 or 3 raters . The ICC for the total score was.56 ( 95 % confidence interval=.47-.65 ) for ratings by individuals , and the ICC for consensus ratings was.68 ( 95 % confidence interval=.57-.76 ) . DISCUSSION AND CONCLUSION The reliability of ratings of PEDro scale items varied from " fair " to " substantial , " and the reliability of the total PEDro score was " fair " to " good . Many r and omised controlled trials have been conducted in China to evaluate the effectiveness of traditional Chinese medicine , but much of the information is inaccessible to Western doctors . We estimated the total number of r and omised controlled trials published in China and identified problems in applying such methodology to the evaluation of traditional Chinese medicine , which would serve as preparatory work for systematic review and dissemination of the r and omised evidence for such medicine . We r and omly selected 28 journals using stratified sampling from a total of 100 Chinese journals of traditional Chinese medicine ( 4 national , 10 university , 10 provincial or regional , and 4 specialist journals ) . After special training , eight fifth year medical students ( working in pairs ) h and search ed all the issues of the journals published before 1 January 1997 to identify r and omised controlled trials . Discrepancies were settled by one of the principal investigators ( S-YZ ) . Data on method ological quality of r and omised controlled trials were extracted from 414 full length articles Wong AMK , Leong CP , Su TY , Yu SW , Tsai WC , Chen CPC : Clinical trial of acupuncture for patients with spinal cord injuries . Am J Phys Med Rehabil 2003;82:21–27 . Objective To examine whether electrical acupuncture therapy through adhesive surface electrodes and concomitant auricular acupuncture therapy could improve the neurologic or functional recovery in acute traumatic spinal cord injury patients . Design A total of 100 acute traumatic spinal cord injury patients with American Spinal Injury Association ( ASIA ) impairment grading of A and B were recruited into this study . They were r and omly divided into the acupuncture and control groups . In the acupuncture group , electrical acupuncture therapy via the adhesive surface electrodes were applied to the bilateral Hou Hsi ( SI3 ) and Shen Mo ( B62 ) acupoints . In auricular acupuncture , four acupoints related to the spinal cord were selected for stimulation at the antihelix , helix , and lower portion of the ear-back areas . Acupuncture therapy was initiated early in the emergency room setting or soon after spinal surgical intervention . Rehabilitation therapy was also provided to the patients during acupuncture therapy . In the control group , only rehabilitation therapy was provided to the patients . Neurologic and functional scores were assessed during the time of admission , hospital discharge , and 1-yr postinjury follow-up . Results There were significant improvements in neurologic ( sensory and motor ) , functional , and FIM ™ scores in the acupuncture group compared with the initial admission period when assessed during the time of hospital discharge and the 1-yr postinjury follow-up . A greater percentage of patients in the acupuncture group recovered to a higher ASIA impairment grading . Conclusion The use of concomitant auricular and electrical acupuncture therapies , when implemented early in acute spinal cord injury , can contribute to significant neurologic and functional recoveries OBJECTIVE To determine the effectiveness of acupuncture and Trager Psychophysical Integration ( a form of manual therapy ) in decreasing chronic shoulder pain in wheelchair users with spinal cord injury ( SCI ) . DESIGN A prospect i ve clinical trial , with subjects r and omized to acupuncture or Trager treatment condition . Subjects served as their own controls by including a 5-week pretreatment baseline period and a 5-week posttreatment follow-up period . SETTING Rehabilitation hospital research department . PARTICIPANTS Eighteen subjects with chronic SCI and chronic shoulder pain who used manual wheelchairs as their primary means of mobility . INTERVENTION Ten acupuncture or 10 Trager treatments over a 5-week period . MAIN OUTCOME MEASURES Changes in performance-corrected Wheelchair User 's Shoulder Pain Index ( PC-WUSPI ) scores during baseline , treatment , and follow-up periods were assessed by using analysis of variance . RESULTS The mean PC-WUSPI score + /- st and ard deviation of the 18 subjects at entry was 48.9 + /- 24.6 ( range , 8.0 - 94 ) . No significant change in mean PC-WUSPI scores occurred during the pretreatment baseline period . Mean PC-WUSPI scores decreased significantly during the treatment period in both the acupuncture ( 53.4 % ; 23.3 points ) and Trager ( 53.8 % ; 21.7 points ) treatment groups . The reduced PC-WUSPI scores were maintained in both groups throughout the 5-week posttreatment follow-up period . CONCLUSION Acupuncture and Trager are both effective treatments for reducing chronic shoulder pain associated with functional activities in persons with SCI OBJECTIVE To explore a more effective therapy for retention of urine induced by spinal cord injury . METHODS Eighty-four cases were r and omly divided into a treatment group of 46 cases and a control group of 38 cases . The treatment group were treated with electroacupuncture at Baliao and Huiyang ( BL 35 ) , and the control group with electroacupuncture at acupoints routinely selected . RESULTS The total effective rate and the cured rate were 82.6 % and 43.5 % in the treatment group and 63.2 % and 23.7 % in the control group respectively , with a very significant difference between the two groups ( P < 0 . 01 ) . CONCLUSION Electroacupuncture at Baliao and Huiyang ( BL 35 ) has obvious therapeutic effect on retention of urine induced by spinal cord injury OBJECTIVE To study whether acupuncture on the acupoints of the affected extremities was effective or not on the lower extremity spasm in spinal injury , and observe the tolerance of patients to acupuncture . METHODS The r and om controlled trial of single case was adopted among 9 patients . The heavy manipulation and gentle manipulation of acupuncture on the lower extremities , physical therapy as well as corresponding control therapy ( acupuncture or other therapy on the upper extremities ) were applied to each case separately for 3 cycles of treatment , totally for 29 weeks of treatments . The therapeutic effective outcomes were determined according to the index of clinical spasm , daily spasm frequency and the patient reported outcome . RESULTS None of the three therapies made the index of clinical spasm worse in 9 patients ( all P > 0.05 ) , and there was no significant statistical difference in comparison among three therapies ( P > 0.05 ) . Concerning to the improvement in daily spasm frequency , the result of heavy manipulation therapy was inferior apparently to the other two therapies ( P < 0.05 ) . The outcome report indicated that the patients were unwilling to accept the stimulation induced by heavy manipulation . CONCLUSION The spasm induced by spinal injury can not be aggravated in tendency by acupuncture on the affected extremities . Thus , acupuncture is a kind of safe therapy for spasm . But the heavy manipulation of acupuncture may be the factor to impact the patient for the option of acupuncture treatment OBJECTIVE To explore clinical safety and efficiency of electroacupuncture combined with acupoint-injection of botulinum toxin A for the treatment of muscle spasticity by spinal cord injury . METHODS Thirty-eight patients with muscle spasticity by spinal cord injury were treated from December 2006 to December 2009 including 26 males and 12 females , with an average age of 45.4 years old ranging from 21 to 68 years . The patients were r and omly divided into 3 groups according to admission time , 13 patients in group A were treated with electroacupuncture combined with acupoint-injection of botulinum toxin A , and 13 patients in group B were treated with acupoint-injection botulinum toxin A and 12 patients in group C were treated with electroacupuncture . After 6 months these patients were evaluated by improved muscle Ashworth scoring ( MAS ) and clinical spasticity index ( SCI ) . RESULTS Thirty-eight patients were followed-up at 6 months after the treatment . The result showed that the MAS scores of group A , B , C before treatment were ( 3.10 + /- 0.14 ) , ( 3.20 + /- 0.17 ) , ( 3.10 + /- 0.16 ) respectively and the CSI scores were ( 14.10 + /- 0.14 ) , ( 14.30 + /- 0.11 ) , ( 14.20 + /- 0.12 ) respectively ; there were no statistical different among the three groups ( P > 0.05 ) . After 6 months of treatment , the MAS scores were ( 1.10 + /- 0.16 ) , ( 2.10 + /- 0.13 ) , ( 2.00 + /- 0.14 ) respectively and the CSI scores were ( 9.10 + /- 0.11 ) , ( 12.10 + /- 0.14 ) , ( 13.10 + /- 0.12 ) respectively . The MAS scores and CSI scores of group A were better than the other two groups ( P < 0.05 ) . CONCLUSION The combination of Chinese hydropower needles and acupoints with BTX-A injection can achieve a comprehensive treatment and reduce pain and improve life quality quickly . The electroacupuncture combined with acupoint-inject botulinum toxin A is a noval safe and effective technique for the treatment of muscle spasticity by spinal cord injury
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