[Concept for integrative pain treatment of osteoarthritis of the knee based on the evidence for conservative and complementary therapies]. / Konzept zur integrativen Schmerztherapie bei Gonarthrose unter Beachtung der Evidenz konservativer und komplementärer Verfahren.

BACKGROUND: Osteoarthritis of the knee (gonarthritis) represents a medical challenge. RESEARCH QUESTION: What is the evidence with respect to approaches of complementary medicine and their integration into multimodal pain management concepts? MATERIAL AND METHODS: Qualitative nonsystematic literature search on the epidemiology and pathophysiology as well as informative clinical trials, meta-analyses and clinical guidelines about conservative treatment including complementary therapy for gonarthritis. RESULTS: Osteoarthritis of the knee is a frequent condition with biopsychosocial risks factors for chronification. The German S2k clinical guideline (k = consensus-based, not based on scientific systematic literature searches) published by the Association of the Scientific Medical Societies in Germany (AWMF) in 2017 has not yet been updated. The current guidelines of the American College of Rheumatology (ACR) date from 2020. Both guidelines recommend exercise therapy, weight reduction, short-term analgesics, topical therapy, intra-articular corticoid injections and acupuncture with variable strengths. Furthermore, transcutaneous electrical nerve stimulation (TENS), laser and other electrophysical therapies, shock waves, traction treatment, ergotherapy, comfrey poultices and mudpacks can also be used. Current research supports the benefits of tai chi/qigong and medicinal leaches. CONCLUSION: Complementary treatment approaches, such as acupuncture, tai chi/qigong, topical naturopathic self-treatment and leeches (with limitations) can, in addition to behavioral changes, exercise therapy and short-term pharmacological treatment, be important evidence-based components of integrative pain management concepts, e.g. in terms of an interdisciplinary multimodal pain treatment (IMPT). Besides pain reduction and functional improvement they promote the internal control conviction through the possibility of self-treatment and self-exercise.

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies.

OBJECTIVE: Overview on risks of acupuncture-related adverse events (AEs). DESIGN: Systematic review and meta-analyses of prospective studies. DATA SOURCES: PubMed, Scopus and Embase from inception date to 15 September 2019. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Prospective studies assessing AEs caused by needle acupuncture in humans as primary outcome published in English or German. DATA EXTRACTION AND SYNTHESIS: Two independent researchers selected articles, extracted the data and assessed study quality. Overall risks and risks for different AE categories were obtained from random effects meta-analyses. MAIN OUTCOMES: Overall risk of minor AEs and serious adverse events (SAEs) per patients and per treatments. RESULTS: A total of 7679 publications were identified. Twenty-two articles reporting on 21 studies were included. Meta-analyses suggest at least one AE occurring in 9.31% (95% CI 5.10% to 14.62%, 11 studies) of patients undergoing an acupuncture series and in 7.57% (95% CI 1.43% to 17.95%, 5 studies) of treatments. Summary risk estimates for SAEs were 1.01 (95% CI 0.23 to 2.33, 11 studies) per 10 000 patients and 7.98 (95% CI 1.39 to 20.00, 14 studies) per one million treatments, for AEs requiring treatment 1.14 (95% CI 0.00 to 7.37, 8 studies) per 1000 patients. Heterogeneity was substantial (I2 >80%). On average, 9.4 AEs occurred in 100 treatments. Half of the AEs were bleeding, pain or flare at the needle site that are argued to represent intended acupuncture reaction. AE definitions and assessments varied largely. CONCLUSION: Acupuncture can be considered among the safer treatments in medicine. SAEs are rare, and the most common minor AEs are very mild. AEs requiring medical management are uncommon but necessitate medical competence to assure patient safety. Clinical and methodological heterogeneity call for standardised AE assessments tools, clear criteria for differentiating acupuncture-related AEs from therapeutically desired reactions, and identification of patient-related risk factors for AEs. PROSPERO REGISTRATION NUMBER: CRD42020151930.

Do the effects of acupuncture vary between acupuncturists? Analysis of the Acupuncture Trialists' Collaboration individual patient data meta-analysis.

OBJECTIVES: The degree to which the effects of acupuncture treatment vary between acupuncturists is unknown. We used a large individual patient dataset of trials of acupuncture for chronic pain to assess practitioner heterogeneity. METHODS: Individual patient data linked to identifiable acupuncturists were drawn from a dataset of 39 high-quality trials of acupuncture, where the comparators were either sham acupuncture or non-acupuncture controls, such as standard care or waitlist. Heterogeneity among acupuncturists was assessed by meta-analysis. RESULTS: A total of 1206 acupuncturists in 13 trials were included. Statistically significant heterogeneity was found in trials with sham-control groups (p < 0.0001) and non-acupuncture control groups (p <0.0001). However, the degree of heterogeneity was very small, with the observed distribution of treatment effects virtually overlapping that expected by chance. For instance, for non-acupuncture-controlled trials, the proportion of acupuncturists with effect sizes half a standard deviation greater or less than average was expected to be 34%, but was observed to be 37%. A limitation is that the trials included a relatively limited range of acupuncturists, mainly physician-acupuncturists. DISCUSSION: Although differences in effects between acupuncturists were greater than expected by chance, the degree of variation was small. This suggests that most chronic pain patients in clinical practice would have similar results to those reported in high-quality trials; comparably, we did not find evidence to suggest that greater standardization of acupuncture practice would improve outcomes. Further research needs to be conducted exploring variability using a sample of acupuncturists with a broader range of practice styles, training and experience.

High Temporal Summation of Pain Predicts Immediate Analgesic Effect of Acupuncture in Chronic Pain Patients-A Prospective Cohort Study.

Objectives: This prospective cohort study explored whether two distinguished sensory parameters predicted acupuncture effects in chronic pain patients; namely high temporal summation of pain (TS) indicating spinal synaptic facilitation as well as a low vibration detection threshold (VDT) indicating a loss of Aß-fiber function. Methods: Pinprick induced TS and VDT were assessed by standardized, validated methods at the most painful body site and a pain free control site in 100 chronic pain patients receiving six acupuncture sessions as part of an interdisciplinary multimodal pain treatment (IMPT). Immediate change in pain intensity after the first acupuncture session (first treatment on the first day of IMPT) was assessed by the verbal rating scale (VRS, 0-100). After 4 weeks of treatment, patients indicated in a questionnaire whether acupuncture had relieved pain immediately and whether it had contributed to overall pain reduction and well-being after IMPT. Results: Logistic regression analysis revealed an association between high TS at the control site and a reduction in pain intensity of at least 30% (VRS) after the first acupuncture (OR [95%-CI] 4.3 [1.6-11.8]). Questionnaire ratings of immediate pain relief after acupuncture were associated with high TS at the control site (OR [95%-CI] 3.8 [1.4-10.2] any pain relief, OR [95%-CI] 5.5 [1.7-17.1] over 50% pain reduction) and at the pain site (OR [95%-CI] 3.2 [1.2-8.9] any pain relief). Appraisals of the contribution of acupuncture to overall pain reduction and well-being after IMPT were not associated with TS. The VDT was not associated with any outcome. Conclusion: This explorative study provides first-time evidence that high TS, especially at a pain free control site, but not VDT, might predict immediate analgesic response to acupuncture in chronic pain patients. Thus, highly centrally sensitized chronic pain patients might respond particularly well to acupuncture.

The views of patients, healthcare professionals and hospital officials on barriers to and facilitators of quality pain management in Ethiopian hospitals: A qualitative study.

BACKGROUND: Postoperative pain remains a challenge in the developed world, but the consequences of inadequately treated postoperative pain are particularly severe in low- and middle-income countries. Since 2011, reports have drawn attention to the poor quality of postoperative pain management in Ethiopia; however, our multicenter qualitative study was the first to attempt to understand the factors that are barriers to and facilitators of quality pain managment in the country. To this aim, the study explored the perspectives of patients, healthcare professionals, and hospital officials. We expected that the results of this study would inform strategies to improve the provision of quality pain management in Ethiopia and perhaps even in other low- and middle-income countries. METHODS: This study used a qualitative, descriptive approach in which nine healthcare professionals, nine patients, and six hospital officials (i.e. executives in a managerial or leadership position in administration, nursing, or education) participated in face-to-face, semi-structured interviews. Thematic data analysis was conducted, and patterns were explained with the help of a theoretical framework. FINDINGS: The barriers identified ranged from healthcare professionals' lack of empathy to a positive social appraisal of patients' ability to cope with pain. They also included a lack of emphasis on pain and its management during early medical education, together with the absence of available resources. Enhancing the ability of healthcare professionals to create favorable rapport with patients and increasing the cultural competence of professionals are essential ingredients of future pain education interventions. CONCLUSIONS: Barriers to and facilitators of postoperative pain management do not exist independently but are reciprocally linked. This finding calls for holistic and inclusive interventions targeting healthcare professionals, patients, and hospital officials. The current situation is unlikely to improve if only healthcare professionals are educated about pain physiology, pharmacology, and management. Patients should also be educated, and the hospital environment should be modified to provide high-quality postoperative pain management.

Somatosensory profiles in acute herpes zoster and predictors of postherpetic neuralgia.

This prospective cohort study aimed to characterize the sensory profile during acute herpes zoster (AHZ) and to explore sensory signs as well as physical and psychosocial health as predictors for postherpetic neuralgia (PHN). Results of quantitative sensory testing of 74 patients with AHZ at the affected site and at the distant contralateral control site were compared to a healthy control group. Pain characteristics (Neuropathic Pain and Symptom Inventory and SES), physical functioning, and psychosocial health aspects (Pain Disability Index, SF-36, and STAI) were assessed by questionnaires. Patients with PHN (n = 13) at 6-month follow-up were compared to those without PHN (n = 45). Sensory signs at the affected site were thermal and vibratory hypesthesia, dynamic mechanical allodynia (DMA), pressure hyperalgesia, and high wind-up (18%-29%), as well as paradoxical heat sensations and pinprick hypalgesia (13.5%). The unaffected control site exhibited thermal and vibratory hypesthesia, DMA, and pressure hyperalgesia. Dynamic mechanical allodynia and pinprick hypalgesia were mutually exclusive. Postherpetic neuralgia was associated with DMA (38.5% vs 6.7%; P = 0.010) and vibratory hypesthesia (38.5% vs 11.1%; P = 0.036) at the control site, with mechanical gain and/or loss combined with normal thermal detection (affected site: 69.2% vs 31.1%; P = 0.023; control site: 53.8% vs 15.5%; P = 0.009). Pain Disability Index (P = 0.036) and SES affective pain perception scores (P = 0.031) were over 50% higher, and 6 of 8 SF-36 subscores were over 50% lower (P < 0.045) in PHN. Sensory profiles in AHZ indicate deafferentation and central but not peripheral sensitization. Sensory signs at distant body sites, strong affective pain perception, as well as reduced quality of life and physical functioning in the acute phase may reflect risk factors for the transition to PHN.

Acupuncture for Chronic Pain: Update of an Individual Patient Data Meta-Analysis.

Despite wide use in clinical practice, acupuncture remains a controversial treatment for chronic pain. Our objective was to update an individual patient data meta-analysis to determine the effect size of acupuncture for 4 chronic pain conditions. We searched MEDLINE and the Cochrane Central Registry of Controlled Trials randomized trials published up until December 31, 2015. We included randomized trials of acupuncture needling versus either sham acupuncture or no acupuncture control for nonspecific musculoskeletal pain, osteoarthritis, chronic headache, or shoulder pain. Trials were only included if allocation concealment was unambiguously determined to be adequate. Raw data were obtained from study authors and entered into an individual patient data meta-analysis. The main outcome measures were pain and function. An additional 13 trials were identified, with data received for a total of 20,827 patients from 39 trials. Acupuncture was superior to sham as well as no acupuncture control for each pain condition (all P < .001) with differences between groups close to .5 SDs compared with no acupuncture control and close to .2 SDs compared with sham. We also found clear evidence that the effects of acupuncture persist over time with only a small decrease, approximately 15%, in treatment effect at 1 year. In secondary analyses, we found no obvious association between trial outcome and characteristics of acupuncture treatment, but effect sizes of acupuncture were associated with the type of control group, with smaller effects sizes for sham controlled trials that used a penetrating needle for sham, and for trials that had high intensity of intervention in the control arm. We conclude that acupuncture is effective for the treatment of chronic pain, with treatment effects persisting over time. Although factors in addition to the specific effects of needling at correct acupuncture point locations are important contributors to the treatment effect, decreases in pain after acupuncture cannot be explained solely in terms of placebo effects. Variations in the effect size of acupuncture in different trials are driven predominantly by differences in treatments received by the control group rather than by differences in the characteristics of acupuncture treatment. PERSPECTIVE: Acupuncture is effective for the treatment of chronic musculoskeletal, headache, and osteoarthritis pain. Treatment effects of acupuncture persist over time and cannot be explained solely in terms of placebo effects. Referral for a course of acupuncture treatment is a reasonable option for a patient with chronic pain.

Acupuncture for Symptom Relief in Palliative Care-Study Protocol and Semistandardized Treatment Schemes.

The use of complementary and alternative medicine methods such as acupuncture in palliative care has increased over the past years. Well-planned trials are warranted to show its effectiveness in relieving distressing symptoms. The development of treatment schemes to be used in the trial for both acupuncture and medical symptom control is challenging, as both acupuncture and palliative care are highly individualized. Thus, standardized care plans of a randomized controlled trial will have difficulties in producing treatment results that compare to the clinical practice. As an alternative, treatment protocols for both acupuncture and medical symptom control of dyspnea, pruritus, hypersalivation, depression, anxiety, and xerostomia were designed with the input of experts. They are designed to provide sufficient symptom control and comparability for a three-arm, randomized controlled trial. Medical symptom control will be provided to all groups. The two control groups will be medical treatment and sham-laser acupuncture.

Electromyogram Biofeedback in Patients with Fibromyalgia: A Randomized Controlled Trial.

BACKGROUND/AIM: Electromyogram (EMG) biofeedback is used in chronic pain but its effectiveness in patients with fibromyalgia is unclear. The objective of this randomized controlled clinical trial was to evaluate the effectiveness of EMG biofeedback in patients with fibromyalgia. METHODS: Patients were recruited from a waiting list at the fibromyalgia day care clinic at the University Hospital Munich. The study intervention comprised 14 sessions of EMG biofeedback during 8 weeks in addition to the usual care. The control intervention was usual care alone. Assessments were scheduled before intervention (T0), after intervention (T1), and 3 months after the end of intervention (T2). The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). Secondary outcome measures included additional patient-oriented measures and the pressure-pain threshold in the trapezius muscles. Effectiveness was analyzed by significance tests and standardized effect sizes (ES). RESULTS: 36 patients completed the study. EMG biofeedback did not improve the health status (FIQ, T1: p = 0.95, ES = 0.02; T2: p = 0.52, ES = 0.26). Among the secondary outcome measures, only the pressure-pain threshold at the trapezius muscles showed an improvement in the intervention group (T1: p = 0.016, ES = 0.84). CONCLUSION: EMG biofeedback showed no health status improvement in patients with fibromyalgia.

WITHDRAWN: Acupuncture for neck disorders.

BACKGROUND: Neck pain is one of the three most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are perceptions of benefit. Acupuncture has been used as an alternative to more conventional treatment for musculoskeletal pain. This review summarises the most current scientific evidence on the effectiveness of acupuncture for acute, subacute and chronic neck pain. This update replaces our 2006 Cochrane review update on this topic. OBJECTIVES: To determine the effects of acupuncture for adults with neck pain, with focus on pain relief, disability or functional measures, patient satisfaction and global perceived effect. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Manual, Alternative and Natural Therapy Index System (MANTIS), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Index to Chiropractic Literature (ICL) from their beginning to August 2015. We searched reference lists, two trial registers and the acupuncture database Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS) in China to 2005. SELECTION CRITERIA: We included published trials that used random assignment to intervention groups, in full text or abstract form. We excluded quasi-randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: Two review authors made independent decisions for each step of the review: article inclusion, data abstraction and assessment of quality of trial methods. We assessed study quality by using the Cochrane Back Review Group 'Risk of bias' tool. We used consensus to resolve disagreements, and when clinical heterogeneity was absent, we combined studies by using random-effects meta-analysis models. MAIN RESULTS: Of the 27 included studies, three represented individuals with whiplash-associated disorders (WADs) ranging from acute to chronic (205 participants), five explored chronic myofascial neck pain (186 participants), five chronic pain due to arthritic changes (542 participants), six chronic non-specific neck pain (4011 participants), two neck pain with radicular signs (43 participants) and six subacute or chronic mechanical neck pain (5111 participants).For mechanical neck pain, we found that acupuncture is beneficial at immediate-term follow-up compared with sham acupuncture for pain intensity; at short-term follow-up compared with sham or inactive treatment for pain intensity; at short-term follow-up compared with sham treatment for disability; and at short-term follow-up compared with wait-list control for pain intensity and neck disability improvement. Statistical pooling was appropriate for acupuncture compared with sham for short-term outcomes due to statistical homogeneity (P value = 0.83; I2 = 20%). Results of the meta-analysis favoured acupuncture (standardised mean difference (SMD) -0.23, 95% confidence interval (CI) -0.20 to -0.07; P value = 0.0006). This effect does not seem sustainable over the long term. Whether subsequent repeated sessions would be successful was not examined by investigators in our primary studies.Acupuncture appears to be a safe treatment modality, as adverse effects are minor. Reported adverse effects include increased pain, bruising, fainting, worsening of symptoms, local swelling and dizziness. These studies reported no life-threatening adverse effects and found that acupuncture treatments were cost-effective.Since the time of our previous review, the quality of RCTs has improved, and we have assessed many of them as having low risk of bias. However, few large trials have provided high-quality evidence. AUTHORS' CONCLUSIONS: Moderate-quality evidence suggests that acupuncture relieves pain better than sham acupuncture, as measured at completion of treatment and at short-term follow-up, and that those who received acupuncture report less pain and disability at short-term follow-up than those on a wait-list. Moderate-quality evidence also indicates that acupuncture is more effective than inactive treatment for relieving pain at short-term follow-up.

Acupuncture for neck disorders.

BACKGROUND: Neck pain is one of the three most frequently reported complaints of the musculoskeletal system. Treatments for neck pain are varied, as are perceptions of benefit. Acupuncture has been used as an alternative to more conventional treatment for musculoskeletal pain. This review summarises the most current scientific evidence on the effectiveness of acupuncture for acute, subacute and chronic neck pain. This update replaces our 2006 Cochrane review update on this topic. OBJECTIVES: To determine the effects of acupuncture for adults with neck pain, with focus on pain relief, disability or functional measures, patient satisfaction and global perceived effect. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Manual, Alternative and Natural Therapy Index System (MANTIS), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) and the Index to Chiropractic Literature (ICL) from their beginning to August 2015. We searched reference lists, two trial registers and the acupuncture database Traditional Chinese Medical Literature Analysis and Retrieval System (TCMLARS) in China to 2005. SELECTION CRITERIA: We included published trials that used random assignment to intervention groups, in full text or abstract form. We excluded quasi-randomised controlled trials (RCTs). DATA COLLECTION AND ANALYSIS: Two review authors made independent decisions for each step of the review: article inclusion, data abstraction and assessment of quality of trial methods. We assessed study quality by using the Cochrane Back Review Group 'Risk of bias' tool. We used consensus to resolve disagreements, and when clinical heterogeneity was absent, we combined studies by using random-effects meta-analysis models. MAIN RESULTS: Of the 27 included studies, three represented individuals with whiplash-associated disorders (WADs) ranging from acute to chronic (205 participants), five explored chronic myofascial neck pain (186 participants), five chronic pain due to arthritic changes (542 participants), six chronic non-specific neck pain (4011 participants), two neck pain with radicular signs (43 participants) and six subacute or chronic mechanical neck pain (5111 participants).For mechanical neck pain, we found that acupuncture is beneficial at immediate-term follow-up compared with sham acupuncture for pain intensity; at short-term follow-up compared with sham or inactive treatment for pain intensity; at short-term follow-up compared with sham treatment for disability; and at short-term follow-up compared with wait-list control for pain intensity and neck disability improvement. Statistical pooling was appropriate for acupuncture compared with sham for short-term outcomes due to statistical homogeneity (P value = 0.83; I(2) = 20%). Results of the meta-analysis favoured acupuncture (standardised mean difference (SMD) -0.23, 95% confidence interval (CI) -0.20 to -0.07; P value = 0.0006). This effect does not seem sustainable over the long term. Whether subsequent repeated sessions would be successful was not examined by investigators in our primary studies.Acupuncture appears to be a safe treatment modality, as adverse effects are minor. Reported adverse effects include increased pain, bruising, fainting, worsening of symptoms, local swelling and dizziness. These studies reported no life-threatening adverse effects and found that acupuncture treatments were cost-effective.Since the time of our previous review, the quality of RCTs has improved, and we have assessed many of them as having low risk of bias. However, few large trials have provided high-quality evidence. AUTHORS' CONCLUSIONS: Moderate-quality evidence suggests that acupuncture relieves pain better than sham acupuncture, as measured at completion of treatment and at short-term follow-up, and that those who received acupuncture report less pain and disability at short-term follow-up than those on a wait-list. Moderate-quality evidence also indicates that acupuncture is more effective than inactive treatment for relieving pain at short-term follow-up.

Acupuncture-induced changes of pressure pain threshold are mediated by segmental inhibition--a randomized controlled trial.

Our aim was to distinguish between spinal and supraspinal mechanisms in the intact nervous system by comparing homosegmental and heterosegmental effects of electroacupuncture (EA) and manual acupuncture (MA) on sensory perception in healthy volunteers by means of quantitative sensory testing. Seventy-two healthy volunteers were randomly assigned to receive either MA or EA at SP 6, SP 9, GB 39, and ST 36 at the left leg or relaxed for 30 minutes (control group [CG]). Blinded examiners assessed 13 sensory modalities (thermal and mechanical detection and pain thresholds) at the upper arms and lower legs before and after intervention by means of a standardized quantitative sensory testing battery. Change scores of all 13 sensory thresholds were compared between groups. The main outcome measure was the change score of the pressure pain threshold (PPT). There were no baseline differences between groups. Pressure pain threshold change scores at the lower left leg, in the same segment as the needling site, differed significantly (P = 0.008) between the EA (median: 103.01 kPa) and CG groups (median: 0.00 kPa) but not between the MA (median: 0.00 kPa) and CG groups. No further significant change score differences were found between one of the acupuncture groups and the CG. The PPT can be changed by EA. The PPT increase was confined to the segment of needling, which indicates that it is mainly mediated by segmental inhibition in the spinal cord. This underscores the importance of segmental needling and electrical stimulation in clinical practice.

Hypnotic relaxation results in elevated thresholds of sensory detection but not of pain detection.

BACKGROUND: Many studies show an effectiveness of hypnotic analgesia. It has been discussed whether the analgesic effect is mainly caused by the relaxation that is concomitant to hypnosis. This study was designed to evaluate the effects of hypnotic relaxation suggestion on different somatosensory detection and pain thresholds. METHODS: Quantitative sensory testing (QST) measurements were performed before and during hypnosis in twenty-three healthy subjects on the dorsum of the right hand. Paired t-test was used to compare threshold changes. The influence of hypnotic susceptibility was evaluated by calculating correlation coefficients for threshold changes and hypnotic susceptibility (Harvard group scale). RESULTS: During hypnosis significantly changed somatosensory thresholds (reduced function) were observed for the following sensory detection thresholds: Cold Detection Threshold (CDT), Warm Detection Threshold (WDT), Thermal Sensory Limen (TSL) and Mechanical Detection Threshold (MDT). The only unchanged sensory detection threshold was Vibration Detection Threshold (VDT). No significant changes were observed for the determined pain detection thresholds (Cold Pain Thresholds, Heat Pain Thresholds, Mechanical Pain Sensitivity, Dynamic Mechanical Allodynia, Wind-up Ratio and Pressure Pain Threshold). No correlation of hypnotic susceptibility and threshold changes were detected. CONCLUSION: Hypnotic relaxation without a specific analgesic suggestion results in thermal and mechanical detection, but not pain threshold changes. We thus conclude that a relaxation suggestion has no genuine effect on sensory pain thresholds. TRIAL REGISTRATION: ClinicalTrials.gov, Identifier: NCT02261155 (9th October 2014).

Effects of acupuncture on sensory perception: a systematic review and meta-analysis.

BACKGROUND: The effect of acupuncture on sensory perception has never been systematically reviewed; although, studies on acupuncture mechanisms are frequently based on the idea that changes in sensory thresholds reflect its effect on the nervous system. METHODS: Pubmed, EMBASE and Scopus were screened for studies investigating the effect of acupuncture on thermal or mechanical detection or pain thresholds in humans published in English or German. A meta-analysis of high quality studies was performed. RESULTS: Out of 3007 identified articles 85 were included. Sixty five studies showed that acupuncture affects at least one sensory threshold. Most studies assessed the pressure pain threshold of which 80% reported an increase after acupuncture. Significant short- and long-term effects on the pressure pain threshold in pain patients were revealed by two meta-analyses including four and two high quality studies, respectively. In over 60% of studies, acupuncture reduced sensitivity to noxious thermal stimuli, but measuring methods might influence results. Few but consistent data indicate that acupuncture reduces pin-prick like pain but not mechanical detection. Results on thermal detection are heterogeneous. Sensory threshold changes were equally frequent reported after manual acupuncture as after electroacupuncture. Among 48 sham-controlled studies, 25 showed stronger effects on sensory thresholds through verum than through sham acupuncture, but in 9 studies significant threshold changes were also observed after sham acupuncture. Overall, there is a lack of high quality acupuncture studies applying comprehensive assessments of sensory perception. CONCLUSIONS: Our findings indicate that acupuncture affects sensory perception. Results are most compelling for the pressure pain threshold, especially in pain conditions associated with tenderness. Sham acupuncture can also cause such effects. Future studies should incorporate comprehensive, standardized assessments of sensory profiles in order to fully characterize its effect on sensory perception and to explore the predictive value of sensory profiles for the effectiveness of acupuncture.

Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial.

BACKGROUND: We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. METHODS/DESIGN: The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to 'ready for discharge' from the post anaesthesia care unit (in minutes). The 'ready for discharge' end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). DISCUSSION: The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. TRIAL REGISTRATION: NCT01816386 (First received: 28 October 2012).

A randomised multicentre trial of acupuncture in patients with seasonal allergic rhinitis--trial intervention including physician and treatment characteristics.

BACKGROUND: In a large randomised trial in patients with seasonal allergic rhinitis (SAR), acupuncture was superior compared to sham acupuncture and rescue medication. The aim of this paper is to describe the characteristics of the trial's participating physicians and to describe the trial intervention in accordance with the STRICTA (Standards for Reporting Interventions in Controlled Trials of Acupuncture) guidelines, to make details of the trial intervention more transparent to researchers and physicians. METHODS: ACUSAR (ACUpuncture in Seasonal Allergic Rhinitis) was a three-armed, randomised, controlled multicentre trial. 422 SAR patients were randomised to semi-standardised acupuncture plus rescue medication (RM, cetirizine), sham acupuncture plus RM or RM alone. We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture. During the trial, acupuncturists were asked to diagnose all of their patients according to Chinese Medicine (CM) as a basis for the semi-standardised, individualized intervention in the acupuncture group. Every acupuncture point used in this trial had to be documented after each session RESULTS: Acupuncture was administered in outpatient clinics by 46 (mean age 47 ± 10 years; 24 female/ 22 male) conventionally-trained medical doctors (67% with postgraduate specialization such as internal or family medicine) with additional extensive acupuncture training (median 500 hours (1st quartile 350, 3rd quartile 1000 hours with 73% presenting a B-diploma in acupuncture training (350 hours)) and experience (mean 14 years in practice). The most reported traditional CM diagnosis was 'wind-cold invading the lung' (37%) and 'wind-heat invading the lung' (37%), followed by 'lung and spleen qi deficiency' (9%). The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group (15.7 ± 2.5 vs. 10.0 ± 1.6). CONCLUSIONS: The trial interventions were provided by well educated and experienced acupuncturists. The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients. For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00610584.

Impact of surgical intervention and postoperative pain on electrical skin resistance at acupuncture points: an exploratory study.

OBJECTIVES: One theory about acupuncture suggests that pathological processes can cause measurable changes in electrical skin resistance (ESR) at acupuncture points (APs). Although the theory has yet to be proven, ESR measurements (ESRMs) form a frequently used part of contemporary acupuncture. The aim of this study was to test the so-called 'electrical responsiveness' of APs in the setting of a defined operative trauma. METHODS: ESRMs (n=424) were performed at the APs and surrounding skin of GB34 and ST38 in 163 participants using an impedance meter array developed for the purpose of ESRMs. For each group the percentage of measurements with a significantly different ESR between the APs and the surrounding skin was calculated and compared with each other. Measurements of four groups were compared: healthy control subjects (n=30) and patients after ophthalmic (n=29), hip (n=42) and shoulder (n=30) surgery. The influence of postoperative pain intensity was also assessed. RESULTS: Group comparison showed no significant differences for ST38. The ESRMs at GB34 had a significantly higher percentage of measurements with an increased ESR after ophthalmic (23.2%) and hip (22.2%) surgery, but not after shoulder surgery (7.5%). Subgroup analysis showed that an increase in pain intensity tended to lead to a decrease in the number of APs with ESR changes. CONCLUSION: These results suggest that reactive changes in ESR at APs might exist. Pain and alertness seem to have an impact on ESR at APs. However, the current data do not allow for conclusions to be drawn concerning the clinical use of ESRMs.

Acupuncture point localization varies among acupuncturists.

BACKGROUND: Studies assessing the point-specific effect of acupuncture or the characteristics of acupuncture points (APs) tend to yield inconclusive results. In order to identify a possible confounding factor, we aimed to examine the variability in AP localization by means of a survey. MATERIAL AND METHODS: Attendees of the 14th ICMART (International Council of Medical Acupuncture and Related Techniques) congress as well as DÄGfA (German Medical Society of Acupuncture) lecturers and students were asked to locate and mark the APs LI 10 and TH 5 on a research assistant's arm. Identified points were transferred into a coordinate system, and the respective bivariate distribution function was calculated. Additionally, participants filled out a questionnaire about their acupuncture education and experience, the acupuncture style and point localization techniques used most frequently, and their estimation of the size of an AP. RESULTS: The areas of the ellipses, theoretically containing 95% of AP localizations, varied between 44.49 and 5.18 cm(2). The largest distance between 2 identified points was 8.45 cm for LI 10 and 5.3 cm for TH 5. Apart from being trained at the same school, no other factor could be identified that determined the variability in AP localization. CONCLUSION: Our results indicate that congruity of AP localization among experienced acupuncturists might be low. Although there are some limitations to our results, this possible bias should be taken into account when conducting acupuncture trials and interpreting results of previous acupuncture studies.

Is sham laser a valid control for acupuncture trials?

Methodological problems of acupuncture trials focus on adequate placebo controls. In this trial we evaluated the use of sham laser acupuncture as a control procedure. Thirty-four healthy volunteers received verum laser (invisible infrared laser emission and red light, 45 s and 1 J per point) and sham laser (red light) treatment at three acupuncture points (LI4, LU7 and LR3) in a randomized, double-blinded, cross-over design. The main outcome measure was the ratio of correct to incorrect ratings of treatment immediately after each session. The secondary outcome measure was the occurrence of deqi-like sensations at the acupuncture points and their intensity on a 10-fold visual analog scale (VAS; 10 being the strongest sensible sensation). We pooled the results of three former trials to evaluate the credibility of sham laser acupuncture when compared to needle acupuncture. Fifteen out of 34 (44%) healthy volunteers (age: 28 ± 10.7 years) identified the used laser device after the first session and 14 (41%) after the second session. Hence, both treatments were undistinguishable (P = .26). Deqi-like sensations occurred in 46% of active laser (2.34 VAS) and in 49.0% of sham laser beams (2.49 VAS). The credibility of sham laser was not different from needle acupuncture. Sham laser acupuncture can serve as a valid placebo control in laser acupuncture studies. Due to similar credibility and the lack of sensory input on the peripheral nervous system, sham laser acupuncture can also serve as a sham control for acupuncture trials, in order to evaluate needling effects per se.