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OBJECTIVE AND AIM To describe differences in pain locations for onset, peak, and radiation aspects of cluster headache (CH) attacks. METHODS AND MATERIALS Data were collected for 23 months using a cross-sectional online survey composed of 117 questions on pain location, demographics, and clinical features. 5260 datapoints on 44 pain locations from 631 respondents were analyzed. RESULTS During the onset and peak of attacks, pain is concentrated periorbitally. Pain locations outside the periorbital region were reported more frequently for radiation than for onset and peak of attacks. Dorsal (occipital, neck, shoulder) pain was reported more frequently in connection with onset and radiation than during peak: onset (13%) versus peak (6%), p

Background Cluster headache (CH) is considered to be a catastrophic disease presenting the most severe human pain condition. Available pharmacological treatments are hampered by unwanted side effects, and there is an urgent need for non-pharmacological treatment alternatives. We present a novel therapeutic approach for chronic CH, having evolved from an episodic CH, using a non-invasive percutaneous bioelectric current stimulation (PBCS), which generates static electric fields in the range of the naturally occurring electric potentials. Patients and methods This study employed a retrospective data analysis of 20 cases of chronic cluster headache (CCH) patients, four of those having had cluster-related surgery (SPG, ONS). All patients were treated with PBCS between 2014 and 2018. Data of these patients were analyzed with respect to frequency of CH attacks and triptan application and followed up for one (20 cases) or two (12 cases) years. Results Four weeks after the first PBCS treatment, cluster headache attacks were reduced from 2.8 to 1.7 per day and triptan application decreased from 2.5 to 1.5 times/day. Six non-responders, 4 of which had pre-CH surgery, did not show any reaction to PBCS, while 14 responders improved within 4 weeks from 2.2 to 0.7 attacks/day and 2.0 to 0.4 triptan applications/day. A 50% or greater reduction of attack frequency was observed in 10 patients after 4 weeks and in 11 patients after 12 weeks. One year after the first treatment, 13/20 patients experienced a reduction of attack frequency of 50% or more, while remarkably 10 patients were completely free of attack. After 2 years, 8 of 12 patients experienced a reduction of attack frequency of 50% or more and 7 of those were completely symptom-free. No serious adverse effects were observed. Conclusion PBCS is a promising transformative treatment approach for CCH patients. Drug consumption was reduced significantly, and the CCH may revert back to an episodic cluster headache with increasingly long times of remission. Responders can be clearly differentiated from non-responders. The data support the need for randomized controlled trials.

Background and Objective:Applying local treatments like neuromodulation or injections for cluster headache, requires exact knowledge of the anatomical structures and pain topography. However studies with emphasis on exact pain localization are rare although local treatments are increasingly used for patients in whom systemic pharmacotherapy is ineffective or contraindicated. Here, survey results with emphasis on exact pain location in cluster headache attacks for onset of pain, peak pain and radiation of pain, are presented. Methods: Data from 631 respondents were collected for 23 months using an online survey composed of 117 questions on pain location, epidemiology, and clinical features. 5260 datapoints on 44 pain locations were analyzed.Results: There is a periorbital concentration of pain during onset and peak phases of attacks. Pain locations outside the periorbital region were reported more frequently during radiation when compared to the onset and peak of attacks. Dorsal (occipital/nuchal) pain is more frequent during onset and radiation compared to peak: onset pain (13%) vs. peak pain (6%), p < 0,001. Pain radiation (22%) vs. peak pain (6%), p < 0,001. There is no significant difference in dorsal pain frequencies for pain radiation (22%) vs. onset (13%), p = 0,552. Furthermore, single pain spots differ significantly in frequency during the three attack phases.Conclusions: Analysis of the pain location data shows phase specific frequencies and distributions of pain location during the three stages of a cluster headache attack. Single pain spots differ significantly in frequency during the three attack phases. Dorsal pain is more frequent during onset and radiation, compared to peak. Extra-orbital pain locations are more frequent during pain radiation. These findings will help to better understand cluster headache and might help to identify further target structures for local treatments.

Albrecht Molsberger,1,2,* Colin D McCaig3,* 1Department of Orthopedics, Ruhr-University Bochum, Bochum, Germany; 2Clinic for Orthopedics and Pain Treatment, Düsseldorf, Germany; 3Institute of Medical Sciences, University of Aberdeen, Aberdeen, Scotland *These authors contributed equally to this work Abstract: There is a high medical need to improve the effectiveness of the treatment of pain and traumatic soft tissue injuries. In this context, electrostimulating devices have been used with only sporadic success. There is also much evidence of endogenous electrical signals that play key roles in regulating the development and regeneration of many tissues. Transepithelial potential gradients are one source of the direct current (DC) electrical signals that stimulate and guide the migration of inflammatory cells, epithelial cells, fibroblasts and mesenchymal stem cells to achieve effective wound healing. Up to now, this electrophysiological knowledge has not been adequately translated into a clinical treatment. Here, we present a mobile, handheld electroceutical smart device based on a microcontroller, an analog front end and a battery, which generates DC electric fields (EFs), mimicking and modulating the patient’s own physiological electrical signals. The electrical stimulation is applied to percutaneous metal probes, which are located close to the inflamed or injured tissue of the patient. The treatment can be used in an ambulatory or stationary environment. It shows unexpectedly, highly effective treatment for certain severe neurological pain conditions, as well as traumatic soft tissue injuries (muscle/ligament ruptures, joint sprains). Without EF intervention, these conditions, respectively, are either virtually incurable or take several months to heal. We present three cases – severe chronic cluster headache, acute massive muscle rupture of the rectus femoris and an acute ankle sprain with a ruptured anterior talofibular ligament – to demonstrate clinical effectiveness and discuss the fundamental differences between mimicking DC simulation and conventional transcutaneous electric nerve stimulation (TENS) or TENS-like implanted devices as used for peripheral nerve cord, spinal cord or dorsal root stimulation. Keywords: electroceutical device, tissue regeneration, pain, direct current stimulation, electric field&nbsp

In den offentlichen Medien und in der Akupunkturliteratur finden sich Hinweise auf alleinige Akupunkturanasthesie bei Operationen. Der in Akupunktur erfahrene Autor prufte im Selbstversuch die Wirkung

The German Randomized Acupuncture Trial for chronic shoulder pain (GRASP) comprised 424 outpatients with chronic shoulder pain (CSP)or =6 weeks and an average pain score of VASor =50 mm, who were randomly assigned to receive Chinese acupuncture (verum), sham acupuncture (sham) or conventional conservative orthopaedic treatment (COT). The patients were blinded to the type of acupuncture and treated by 31 office-based orthopaedists trained in acupuncture; all received 15 treatments over 6 weeks. The 50% responder rate for pain was measured on a VAS 3 months after the end of treatment (primary endpoint) and directly after the end of the treatment (secondary endpoint).In the ITT (n=424) analysis, percentages of responders for the primary endpoint were verum 65% (95% CI 56-74%) (n=100), sham 24% (95% CI 9-39%) (n=32), and COT 37% (95% CI 24-50%) (n=50); secondary endpoint: verum 68% (95% CI 58-77%) (n=92), sham 40% (95% CI 27-53%) (n=53), and COT 28% (95% CI 14-42%) (n=38). The results are significant for verum over sham and verum over COT (p0.01) for both the primary and secondary endpoints. The PPP analysis of the primary (n=308) and secondary endpoints (n=360) yields similar responder results for verum over sham and verum over COT (p0.01). Descriptive statistics showed greater improvement of shoulder mobility (abduction and arm-above-head test) for the verum group versus the control group immediately after treatment and after 3 months. The trial indicates that Chinese acupuncture is an effective alternative to conventional orthopaedic treatment for CSP.

Eine ganzheitliche Rehabilitation bedarf eines multidisziplinaren Behandlungsansatzes. Dazu stehen eine Vielzahl von therapeutischen Ansatrzen und Methoden zur Verfugung. Das folgende Kapitel stellt die Basismethoden in der orthopadisch-traumatologischen Rehabilitation vor. Die sbeinhaltet die Methoden der Krankengymnastik, der Ergo-, Sport- und Bewegungstherapie, die breite Palette der physikalischen Therapie (Massagen, Thermo-, Hydro- und Balneotherapie, Elektrotherapie und Traktionsbehandlung), der manuellen Therapie, die arztlichen Behandlungsverfahren der orthopadischen Schmerztherapie( man. Medizin, medikamentose und interventionelle Schmerztherapie, Akupunktur, technische Orthopadie), sowei die Verfahren der psychosomatischen Behandlungen und das wichtige Kapitel der Patientenschulung und Sozialberatung und - medizin dar.

In the nationwide German Acupuncture Trials (GERAC), verum acupuncture, mirroring the Traditional Chinese Medicine (TCM) acupuncture style, was tested against sham acupuncture and guideline standard therapy for the entities classified in the West as chronic low back pain (LBP) and gonarthrosis (GON).The objective was to develop broadly consensual acupuncture and control protocols for the treatment of LBP and GON in the GERAC trials.Extensive literature study and consultation with acupuncture experts were consulted. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used as well.Broadly consensual acupuncture protocols for LBP and GON for verum and invasive sham acupuncture were developed. They included semistandardized point combinations with clearly described point selection rules based on TCM acupuncture diagnosis. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial.With 1162 randomized patients for LBP and 1039 patients for GON, the GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of LBP and GON.

In the nationwide German Acupuncture Trials (GERAC) verum acupuncture, based on Traditional Chinese Medicine (TCM), was to be tested against sham acupuncture for the entities classified in the West as "migraine" (MIG) and "tension-type headache" (TTH). However, there were no generally accepted guidelines on how to perform a consistent verum or sham treatment.To design broadly consensual verum and sham acupuncture treatment protocols for MIG and TTH for the GERAC.Extensive literature study and consultation with acupuncture experts. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used.Broadly consensual acupuncture protocols for MIG and TTH for verum and sham acupuncture were developed. They included semi-standardized point combinations with clearly described point selection rules based on TCM acupuncture diagnoses. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial.The GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and the large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of MIG and TTH.

Background Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment. Methods This study was a prospective, randomised, multicentre, doubleblind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n = 313), sham acupuncture (n = 339), or standard therapy (n = 308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23–26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557. Findings Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat population and 443 in the perprotocol population. The primary outcome showed a mean reduction of 23 days (95 % CI 1·9–2·7) in the verum acupuncture group, 15 days (11–20) in the sham acupuncture group, and 21 days (15–27) in the standard therapy group. These differences were statistically significant compared with baseline (p < 0.0001), but not across the treatment groups (p = 0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50 %, 26 weeks after randomisation, was 47 % in the verum group, 39 % in the sham acupuncture group, and 40 % in the standard group (p = 0.133). Interpretation Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

Widerspruchliche Studienaussagen zur Wirksamkeit von Korperakupunktur bei Schmerzen werden oft auf methodische Mangel zuruckgefuhrt. Das hier vorgestellte Studiendesign der German Acupuncture Trials (gerac) zeigt, dass auch bei Akupunkturstudien die Prinzipien von „good clinical practice“ strikt eingehalten werden konnen. Rund 1000 Patienten/Indikation (Migrane, Spannungskopfschmerz, Lumbalgie, Gonarthrose). Randomisierte Zuteilung auf Verum-, Sham-Akupunktur oder leitlinienorientierte Standardtherapie. Alle Patienten erhalten 10 Behandlungen (2/Woche) mit Verlangerungsmoglichkeit um 5 weitere Behandlungen, je nach Behandlungsergebnis. Akupunkturpatienten sind gegenuber der Akupunkturtherapie verblindet. Prufarzte sind niedergelassene Arzte mit mindestens einem A-Diplom in Akupunktur. Obligatorische und fakultative Akupunkturpunkte sind vorgegeben. Individuelle Auswahl nach TCM-Kriterien. Primare Zielkriterien sind die monatliche Anzahl an Kopfschmerztagen (Kopfschmerz), der Graded Chronic Pain Scale nach von Korff oder der Funktionsfragebogen Hannover-Rucken (Lumbalgie), der WOMAC-Score (Gonarthrose). Datenerhebung durch nicht an der Behandlung beteiligte Telefoninterviewer, verblindet gegenuber der Akupunkturtherapie. Uber 500 Prufarzte in 10 Regionen. Die Patientenrekrutierungen fur Lumbalgie und Gonarthrose konnten im November 2003 bzw. Marz 2004 abgeschlossen werden. Die Rekrutierungsphase der beiden Kopfschmerzstudien wird im Herbst 2004 beendet. Gerac zeigt, dass methodisch hochwertige Akupunkturstudien moglich sind. Die Ergebnisse werden eine Basis fur die Bewertung der Akupunktur bilden, in und auserhalb Deutschlands.

Background: The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies, leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain (GERAC-cLBP) study. Objective: The aim is to assess the effectiveness of traditional Chinese acupuncture for chronic low-back pain compared to sham acupuncture and with a conventional standard therapy. Methods: This trial is a nationwide, multicenter, randomized, prospective, partially blinded study. The primary endpoint is the success rate after 6 months. Success is defined as an improvement of 33% or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12% or more in the disability measured by the Hanover Functional Ability Questionnaire. Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted. All clinical endpoints are assessed centrally by blinded independent observers. Th...

information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use. Main Results: Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acuteheadachesorroutinecareonly.Both found statistically significant and clinically relevant short-term (up to three months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond three months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for metaanalyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret,butcollectivelysuggestslightlybetter results for some outcomes in the control groups. Conclusions: In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable nonpharmacological tool in patients with frequent episodic or chronic tension-type headaches.

88 klinische Akupunkturstudien zur Erkrankungen des Bewegungsapparats und Schmerzerkrankungen des Kopfs werden hinsichtlich ihrer handwerklichen Qualitat in 6 Kategorien unterteilt und bewertet. Fur die Beurteilung der Akupunkturqualitat wurden Mindestanforderungen definiert: Angabe zur Dauer einer Akupunktursitzung (gefordert mindestens 15 min), Angabe zur Haufigkeit von Akupunkturanwendungen (gefordert mindestens 10 Sitzungen vor Abbruch der Therapie) und genaue Beschreibung der gestochenen Akupunkturpunkte. Unabhangig von handwerklichen und biometrischen Mangeln zeigen 75 von 88 Studien (85,2%) ein positives Ergebnis der Akupunktur. Keine der 16 Studien, die den handwerklichen Mindestanforderungen genugten, konnte eine fehlende Wirksamkeit der Akupunktur nachweisen. Von diesen 16 Studien sind 3 Studien kontrolliert. Die Ergebnisse der Untersuchung werden mit Metaanalysen verglichen, die Akupunkturstudien allein hinsichtlich der biometrischen Qualitat untersuchten. Die Wertigkeit der Akupunkturtherapie bei orthopadischen Erkrankungen im Vergleich zu konventionellen Therapieverfahren wird diskutiert, und es werden Empfehlungen zu Akupunkturindikationen bei Schmerzerkrankungen des Bewegungsapparats herausgearbeitet.

See related research article by Li and colleagues on page [401][1] and at [www.cmaj.ca/lookup/doi/10.1503/cmaj.110551][2] and research article by Smelt and colleagues on page [E224][3] and at [www.cmaj.ca/lookup/doi/10.1503/cmaj.110908][4] In general, the harder a medical problem is to treat, the

OBJECTIVE Playing-related musculoskeletal disorders (PRMD) are common among musicians. Acupuncture is well established in Germany as a treatment for orthopedic conditions, but it is not commonly used in the treatment of PRMD yet. The authors examined the musicians' health literature and provide a brief overview about the background of acupuncture. Three case studies are presented to show possible benefits for the treatment of PRMD. PARTICIPANTS 2456 medical doctors, members of the German research group for acupuncture. METHODS We searched literature and Medline Database for publications about acupuncture, musicians' medicine and musculoskeletal disorders. Additionally we asked medical doctors, via a questionnaire, about the treatment of professional musicians as patients. Case studies are presented. RESULTS No research was found to support the use oft acupuncture in PRMD. The survey study found that medical doctors are not satisfied with the quality of medical health care provided to musicians and regard specialist knowledge as being important. CONCLUSION Evidence on the benefits of acupuncture for musculoskeletal disorders suggests that it could be of benefit as a complementary treatment of PRMD. We suggest performing clinical trials to demonstrate the value of standard treatment, acupuncture and complementary medicine for PRMD.

There are references in the media and in the literature to the use of acupuncture as an anaesthetic in surgical operations. The author, an experienced acupuncturist, tested the anaesthetic effect of acupuncture during an inguinal hernia repair in a self-experiment. Acupuncture combined with electrostimulation was administered for the 6-cm skin cut and preparation to 15 mm in depth. However, acupuncture alone provided an inadequate anaesthetic effect for the entire operation and an additional local anaesthetic had to be administered.

Background: In a previous study it has been shown that acupuncture activates the respiratory burst (RB) of neutrophils as measured by the differences to baseline of the mean channel number of fluorescence intensity (mfi) in volunteers. Since this result could have been affected by a placebo effect, a study has been designed that controls for the different facets of placebo mechanisms such as expectancy, suggestibility, and conditioning. Participants and Methods: 60 healthy volunteers were randomized either to acupuncture of the acupoint Large Intestine 11 (LI 11) (groups 1 and 2) or relaxation (group 3) twice a week for 4 weeks. Only acupuncture group 1 and the relaxation group were provided with the additional suggestion that the treatment may strengthen the immune system. Results: The repeated measurement analysis for differences of follow-ups to baseline showed significantly different treatment effects for neutrophils but not for monocytes (unprimed neutrophils: p = 0.004; neutrophils primed with TNF-alpha/FMLP or with FMLP only: p = 0.026 and p = 0.019, respectively) between groups. For both cell types post-hoc Dunnett’s t-tests using the relaxation group as control showed significantly stronger treatment effects for acupuncture group 1. Combining all priming procedures, the average increase in mfi for both cell types was about 30% greater in acupuncture group 1 than in the relaxation group. Plasma concentrations of pro-inflammatory cytokines only increased significantly in the acupuncture groups. Conclusion: Repetitive acupuncture increases the cytotoxicity of leukocytes in healthy volunteers, which might be intensified by a conditioning-expectation effect.

Chinese acupuncture is widely accepted in western countries, and a number of clinical trials are testing Chinese acupuncture, especially for chronic low back pain (cLBP). However, little is known about how practitioners perform acupuncture treatment in daily clinical work and whether treatment styles differ among practitioners and countries.To investigate whether styles of Chinese acupuncture treatment for cLBP are heterogeneous among different practitioners and countries.Literature review, a prospective survey of international experts using a questionnaire with open and closed questions, and personal interviews.Data were collected from 18 experts in 10 different countries. The typical treatment regimen for cLBP, based on a composite of experts' responses, consisted of 11 sessions lasting 25 minutes each, held twice weekly. The typical practitioner inserted 12 needles, would select individual points according to channels and syndromes, and would identify syndromes such as kidney deficiency (yin and yang), cold dampness, and qi and blood stagnation. Preferred points were BL 23, BL 40, GB 34, BL 54, BL 60, BL 54, and Huatuo, although there was a high variation in additional local and distal points. Generally speaking, no expert would administer fewer than 6 treatments, omit Ahshi points, restrict needle insertion to 1 cm or less, or adhere solely to fixed points for all patients.For the first time it has been shown that there is a broad consistency in fundamental aspects of Chinese acupuncture for cLBP across different kinds of practitioners and different countries. These data can be used as minimal standards for the design and funding of future clinical trials.

On November 8–9, 2007, the Society for Acupuncture Research (SAR) hosted an international conference to mark the tenth anniversary of the landmark National Institutes of Health Consensus Development Conference on Acupuncture. More than 300 acupuncture researchers, practitioners, students, funding agency personnel, and health policy analysts from 20 countries attended the SAR meeting held at the University of Maryland School of Medicine, Baltimore, MD. This paper summarizes important invited lectures in the area of clinical research. Specifically, included are: a review of the recently conducted German trials and observational studies on low-back pain (LBP), gonarthrosis, migraine, and tension-type headache (the Acupuncture Research Trials and the German Acupuncture Trials, plus observational studies); a systematic review of acupuncture treatment for knee osteoarthritis (OA); and an overview of acupuncture trials in neurologic conditions, LBP, women's health, psychiatric disorders, and functional bowel disorders. A summary of the use of acupuncture in cancer care is also provided. Researchers involved in the German trials concluded that acupuncture is effective for treating chronic pain, but the correct selection of acupuncture points seems to play a limited role; no conclusions could be drawn about the placebo aspect of acupuncture, due to the design of the studies. Overall, when compared to sham, acupuncture did not show a benefit in treating knee OA or LBP, but acupuncture was better than a wait-list control and standard of care, respectively. In women's health, acupuncture has been found to be beneficial for patients with premenstrual syndrome, dysmenorrhea, several pregnancy-related conditions, and nausea in females who have cancers. Evidence on moxibustion for breech presentation, induction of labor, and reduction of menopausal symptoms is still inconclusive. In mental health, evidence for acupuncture's efficacy in treating neurologic and functional bowel disorder is still inconclusive. For chronic cancer-related problems such as pain, acupuncture may work well in stand-alone clinics; however, for acute or treatment-related symptoms, integration of acupuncture care into a busy and complex clinical environment is unlikely, unless compelling evidence of a considerable patient benefit can be established.

To our knowledge, verum acupuncture has never been directly compared with sham acupuncture and guideline-based conventional therapy in patients with chronic low back pain.A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean +/- SD age, 50 +/- 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement.At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, -3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P.001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P.001.Low back pain improved after acupuncture treatment for at least 6 months. Effectiveness of acupuncture, either verum or sham, was almost twice that of conventional therapy.

Our aim was to assess the efficacy of a part-standardised verum acupuncture procedure, in accordance with the rules of traditional Chinese medicine, compared with that of part-standardised sham acupuncture and standard migraine prophylaxis with beta blockers, calcium-channel blockers, or antiepileptic drugs in the reduction of migraine days 26 weeks after the start of treatment.This study was a prospective, randomised, multicentre, double-blind, parallel-group, controlled, clinical trial, undertaken between April 2002 and July 2005. Patients who had two to six migraine attacks per month were randomly assigned verum acupuncture (n=313), sham acupuncture (n=339), or standard therapy (n=308). Patients received ten sessions of acupuncture treatment in 6 weeks or continuous prophylaxis with drugs. Primary outcome was the difference in migraine days between 4 weeks before randomisation and weeks 23-26 after randomisation. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN52683557.Of 1295 patients screened, 960 were randomly assigned to a treatment group. Immediately after randomisation, 125 patients (106 from the standard group) withdrew their consent to study participation. 794 patients were analysed in the intention-to-treat popoulation and 443 in the per-protocol population. The primary outcome showed a mean reduction of 2 .3 days (95% CI 1.9-2.7) in the verum acupuncture group, 1.5 days (1.1-2.0) in the sham acupuncture group, and 2.1 days (1.5-2.7) in the standard therapy group. These differences were statistically significant compared with baseline (p0.0001), but not across the treatment groups (p=0.09). The proportion of responders, defined as patients with a reduction of migraine days by at least 50%, 26 weeks after randomisation, was 47% in the verum group, 39% in the sham acupuncture group, and 40% in the standard group (p=0.133).Treatment outcomes for migraine do not differ between patients treated with sham acupuncture, verum acupuncture, or standard therapy.

The efficacy of acupuncture treatment for chronic low-back pain has not been reliably proven because of a lack of good quality studies, leading to the necessity of developing the German Acupuncture Trial for Chronic Low-Back Pain (GERAC-cLBP) study.The aim is to assess the effectiveness of traditional Chinese acupuncture for chronic low-back pain compared to sham acupuncture and with a conventional standard therapy.This trial is a nationwide, multicenter, randomized, prospective, partially blinded study. The primary endpoint is the success rate after 6 months. Success is defined as an improvement of 33% or more of three pain-related items on the Van-Korff Pain Score or an improvement of 12% or more in the disability measured by the Hanover Functional Ability Questionnaire. Assessment of the effectiveness of the blinding of patients to the form of acupuncture they received will be conducted. All clinical endpoints are assessed centrally by blinded independent observers. The sample size, with a total of 1062 patients to be enrolled, is based on power calculations. Independent central randomization, data collection, data processing, and statistical analysis are provided. Success rates will be tested for differences using two-sided Fisher exact tests. In the primary analysis, all tests will be carried out on the basis of the intention-to-treat principle. Secondary analyses will be conducted according to protocol approaches.The pilot phase of the trial started in February 2002, the estimated duration of the study is 2.5 years. Enrollment is anticipated to be completed in the winter of 2003.The GERAC-cLBP study is currently the world's largest controlled trial of the effectiveness of acupuncture treatment for low-back pain. It will contribute to the evaluation of efficacy by means of evidence based medicine.

Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient- and observerblinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as ≥ 10 headache days per month of which ≤ 1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as > 50 % reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33 % of verum patients and 27 % of sham controls (p = 0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95 % CI 0.6, 3.0; p = 0.004) and the International Headache Society response criterion (66 % vs. 55 % response, risk difference 12 %, 95 % CI: 2–21 %; p = 0.024).). The relative risk on the primary and secondary response criterion was very similar (∼ 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.

Methods A patient- and observer-blinded randomized controlled trial conducted in Germany involving 340 outpatient practices, including 1162 patients aged 18 to 86 years (mean ± SD age, 50 ± 15 years) with a history of chronic low back pain for a mean of 8 years. Patients underwent ten 30-minute sessions, generally 2 sessions per week, of verum acupuncture (n = 387) according to principles of traditional Chinese medicine; sham acupuncture (n = 387) consisting of superficial needling at nonacupuncture points; or conventional therapy, a combination of drugs, physical therapy, and exercise (n = 388). Five additional sessions were offered to patients who had a partial response to treatment (10%-50% reduction in pain intensity). Primary outcome was response after 6 months, defined as 33% improvement or better on 3 pain-related items on the Von Korff Chronic Pain Grade Scale questionnaire or 12% improvement or better on the back-specific Hanover Functional Ability Questionnaire. Patients who were unblinded or had recourse to other than permitted concomitant therapies during follow-up were classified as nonresponders regardless of symptom improvement. Results At 6 months, response rate was 47.6% in the verum acupuncture group, 44.2% in the sham acupuncture group, and 27.4% in the conventional therapy group. Differences among groups were as follows: verum vs sham, 3.4% (95% confidence interval, –3.7% to 10.3%; P = .39); verum vs conventional therapy, 20.2% (95% confidence interval, 13.4% to 26.7%; P < .001); and sham vs conventional therapy, 16.8% (95% confidence interval, 10.1% to 23.4%; P < .001.

Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined asor =10 headache days per month of whichor =1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar ( approximately 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.