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AbstractObjectiveTo assess the efficacy of manual acupuncture as prophylactic treatment for acupuncture naive patients with episodic migraine without aura.DesignMulticentre, randomised, controlled clinical trial with blinded participants, outcome assessment, and statistician.SettingSeven hospitals in China, 5 June 2016 to 15 November 2018.Participants150 acupuncture naive patients with episodic migraine without aura.Interventions20 sessions of manual acupuncture at true acupuncture points plus usual care, 20 sessions of non-penetrating sham acupuncture at heterosegmental non-acupuncture points plus usual care, or usual care alone over 8 weeks.Main outcome measuresChange in migraine days and migraine attacks per four weeks during weeks 1-20 after randomisation compared with baseline (four weeks before randomisation).ResultsAmong 150 randomised patients (mean age 36.5 (SD 11.4) years; 123 (82%) women), 147 were included in the full analysis set. Compared with sham acupuncture, manual acupuncture resulted in a significantly greater reduction in migraine days at weeks 13 to 20 and a significantly greater reduction in migraine attacks at weeks 17 to 20. The reduction in mean number of migraine days was 3.5 (SD 2.5) for manual versus 2.4 (3.4) for sham (adjusted difference −1.4, 95% confidence interval −2.4 to −0.3; P=0.005) at weeks 13 to 16 and 3.9 (3.0) for manual versus 2.2 (3.2) for sham (adjusted difference −2.1, −2.9 to −1.2; P<0.001) at weeks 17 to 20. At weeks 17 to 20, the reduction in mean number of attacks was 2.3 (1.7) for manual versus 1.6 (2.5) for sham (adjusted difference −1.0, −1.5 to −0.5; P<0.001). No severe adverse events were reported. No significant difference was seen in the proportion of patients perceiving needle penetration between manual acupuncture and sham acupuncture (79% v 75%; P=0.891).ConclusionsTwenty sessions of manual acupuncture was superior to sham acupuncture and usual care for the prophylaxis of episodic migraine without aura. These results support the use of manual acupuncture in patients who are reluctant to use prophylactic drugs or when prophylactic drugs are ineffective, and it should be considered in future guidelines.Trial registrationClinicaltrials.gov NCT02765581.

Objective To investigate whether placebo effects can experimentally be separated into the response to three components—assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship—and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components.Design A six week single blind three arm randomised controlled trial.Setting Academic medical centre.Participants 262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of ≥150 on the symptom severity scale.Interventions For three weeks either waiting list (observation), placebo acupuncture alone (“limited”), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence (“augmented”). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks.Main outcome measures Global improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life.Results At three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus “limited” versus “augmented,” respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01).Results were similar at six week follow-up.Conclusion Factors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.Trial registration Clinical Trials NCT00065403.

Knee osteoarthritis (KOA) is a prevalent condition causing significant pain and functional impairment. Acupuncture has shown promise as an adjunctive therapy, but conventional manual selection of acupoints lacks standardization. The Acugraph system provides a computerized method for identifying acupoints, potentially enhancing treatment precision. This study aims to compare the effects of computerized Acugraph-guided acupuncture versus manually selected acupuncture as adjuncts to physiotherapy in managing KOA. A randomized, double-blind controlled trial will be conducted with 50 participants diagnosed with mild to moderate KOA. Participants will be randomly assigned to one of two groups: Group 1 Comp-AcuPhysio (n = 25), receiving Acugraph-guided acupuncture with physiotherapy, or Group 2 Man-AcuPhysio (n = 25), receiving manually selected acupuncture with physiotherapy. Both groups will undergo 12 weekly treatment sessions, each lasting 60 minutes. Outcome measures, including the Knee Injury and Osteoarthritis Outcome Score, active knee flexion range, Timed Up and Go test, Visual Analog Scale for pain, Short Form-36 health survey, and Personal Integrated Energetics score, will be assessed at baseline and immediately post-intervention. An intention-to-treat analysis will be applied. Changes from baseline to 12 weeks will be analyzed using repeated measures analysis of variance for both within-group and between-group comparisons. This study will provide a definitive assessment of the effectiveness of computerized Acugraph-guided acupuncture compared to manually selected acupuncture as supplementary treatments alongside KOA physiotherapeutic rehabilitation. This trial will offer insights into how incorporating technology-driven approaches, such as Acugraph, with physiotherapy can enhance the customization and effectiveness of KOA management, leading to improved clinical outcomes. These results could advocate for the integration of technological tools in acupuncture to boost treatment precision and efficacy for KOA. Australian New Zealand Clinical Trials Registry (ACTRN12624000646549p).

Purpose: Chemotherapy-induced peripheral neuropathy is a complex side effect with few available treatment options. The aim of the study was to test the effectiveness of an 8-week course of acupuncture in the management of chemotherapy-induced peripheral neuropathy in cancer patients who were receiving or had received neurotoxic chemotherapy. Methods: Randomized assessor-blinded controlled trial with 2 arms; one arm received acupuncture twice weekly for 8 weeks, while the other arm was a wait-list control group receiving only standard care. Primary outcome was pain intensity and interference over the past week using the Brief Pain Inventory at the end of the intervention. Secondary outcomes included clinical assessment (CTCAE [Common Toxicity Criteria for Adverse Events] grading and Total Neuropathy Score–Clinical Version) and nerve conduction studies; and patient-reported outcome measures (Functional Assessment of Cancer Therapy–Gynecologic Oncology Group–Neurotoxicity Quality of Life scale and Symptom Distress Scale) assessed at baseline, end of treatment (8 weeks), week 14, and week 20 from the beginning of treatment. Results: Eighty-seven patients were randomized to the experimental arm (n = 44) and to the standard care wait-list control arm (n = 43). Significant changes at 8 weeks were detected in relation to primary outcome (pain), the clinical neurological assessment, quality of life domains, and symptom distress (all P < .05). Improvements in pain interference, neurotoxicity-related symptoms, and functional aspects of quality of life were sustained in the 14-week assessment (P < .05), as were physical and functional well-being at the 20-week assessment (P < .05). Conclusions: Acupuncture is an effective intervention for treating chemotherapy-induced peripheral neuropathy and improving patients’ quality of life and experience with neurotoxicity-related symptoms with longer term effects evident.

Prior studies have shown that patients suffering from chronic Low Back Pain (cLBP) have impaired somatosensory processing including reduced tactile acuity, i.e. reduced ability to resolve fine spatial details with the perception of touch. The central mechanism(s) underlying reduced tactile acuity are unknown but may include changes in specific brain circuitries (e.g. neuroplasticity in the primary somatosensory cortex, S1). Furthermore, little is known about the linkage between changes in tactile acuity and the amelioration of cLBP by somatically-directed therapeutic interventions, such as acupuncture. In this longitudinal neuroimaging study, we evaluated healthy control adults (HC, N ​= ​50) and a large sample of cLBP patients (N ​= ​102) with structural brain imaging (T1-weighted MRI for Voxel-Based Morphometry, VBM; Diffusion Tensor Imaging, DTI) and tactile acuity testing using two-point discrimination threshold (2PDT) over the lower back (site of pain) and finger (control) locations. Patients were evaluated at baseline and following a 4-week course of acupuncture, with patients randomized to either verum acupuncture, two different forms of sham acupuncture (designed with or without somatosensory afference), or no-intervention usual care control. At baseline, cLBP patients demonstrated reduced acuity (greater 2PDT, P ​= ​0.01) over the low back, but not finger (P ​= ​0.29) locations compared to HC, suggesting that chronic pain affects tactile acuity specifically at body regions encoding the experience of clinical pain. At baseline, Gray Matter Volume (GMV) was elevated and Fractional Anisotropy (FA) was reduced, respectively, in the S1-back region of cLBP patients compared to controls (P ​< ​0.05). GMV in cLBP correlated with greater 2PDT-back scores (ρ ​= ​0.27, P ​= ​0.02). Following verum acupuncture, tactile acuity over the back was improved (reduced 2PDT) and greater improvements were associated with reduced S1-back GMV (ρ ​= ​0.52, P ​= ​0.03) and increased S1-back adjacent white matter FA (ρ ​= ​−0.56, P ​= ​0.01). These associations were not seen for non-verum control interventions. Thus, S1 neuroplasticity in cLBP is linked with deficits in tactile acuity and, following acupuncture therapy, may represent early mechanistic changes in somatosensory processing that track with improved tactile acuity.

Acupuncture is an evidence-based pain treatment in clinic settings, but its optimal delivery has not been established in emergency departments (EDs). As part of an adaptive pragmatic randomized controlled trial of ED acupuncture for acute musculoskeletal pain (NCT04290741), we embedded a qualitative evaluation of acupuncture treatment acceptability and suggestions for improvement from study participants receiving acupuncture in the ED. Semi-structured interviews conducted remotely evaluated factors impacting patients' perspectives, willingness to participate in, and experiences with ED acupuncture. The codebook was iteratively developed, and recruitment and analysis continued until information saturation was reached. Twenty-eight participants receiving ED acupuncture between February 2020-March 2021 were interviewed, with median age 44 years, 46.4% female, and 61% having never previously received acupuncture. Overall, ED patients with acute musculoskeletal pain expressed interest in acupuncture and reported an overall positive experience. Most reported acupuncture met their expectations for pain improvement, and many reported additional improvements in stress, anxiety, and sleep quality. Participants with a positive experience were more likely to recommend acupuncture to others. Key positive aspects included open communication with compassionate and knowledgeable acupuncturists. Participants found the ED setting acceptable and convenient for receiving acupuncture. Furthermore, participants provided actionable feedback like addressing fear of needles to improve the ED acupuncture experience. In conclusion, ED patients with acute musculoskeletal pain were interested in and had positive experiences with acupuncture treatment for pain and found the ED setting acceptable and convenient. Participant feedback can be used to improve acupuncture treatment in the ED.

Alternative therapeutic strategies for herpes zoster, especially for acute phase pain relief, are still largely unexplored. This study aimed to compare the effects of wrist-ankle acupuncture combined with standard pharmacological treatment versus standard pharmacological treatment alone in relieving pain in the acute phase of herpes zoster. An open-label, randomized, controlled clinical trial was conducted, enrolling patients diagnosed with acute-phase herpes zoster with pain visual analog scale (VAS) scores greater than or equal to 2. The participants were randomly assigned to either the control group receiving standard pharmacological treatment (antiviral therapy combined with pain relievers) alone or the experimental group receiving wrist-ankle acupuncture plus standard pharmacological treatment. VAS pain scores were recorded on days 1–7 and on day 28 after treatment began. Dermatology Life Quality Index scores were assessed both during the pre-treatment phase and at hospital discharge. A total of 106 patients completed the trial protocol and were included in the analysis, with 52 and 54 patients in the control and experimental groups, respectively. The clinical cure rates of pain (the rate of complete absence of pain) in the experimental group was statistically higher than control group on days 7 after treatment began(87.04% vs 65.38%, p < 0.005). The average pain VAS scores of the experimental group were lower than the control group on days 2–6 after treatment began, and they are statistically significant (all p < 0.05). No significant difference was observed between day 7 and day 28 after treatment began ( p  > 0.05). The Dermatology Life Quality Index scores significantly differed at hospital discharge ( p  < 0.05). Side effects did not significantly differ between the two groups (all p  > 0.05). Wrist-ankle acupuncture combined with standard pharmacological treatment may potentially improve the pain cure rate at 7 days post-treatment. This suggests a potential new strategy for alleviating pain in patients in the acute phase of herpes zoster. Trial registration: ChiCTR2300071795.

BACKGROUND: Acupuncture is one of the most widely used therapies to treat chronic low back pain, whose analgesic effect seems to be potentiated by the addition of electric current (electroacupuncture). However, we are not aware of any clinical trial that has evaluated the effectiveness of this technique in adults > 65 years. OBJECTIVE: To evaluate the effect of electroacupuncture in the treatment of chronic low back pain in the elderly. STUDY DESIGN: Triple-blind, controlled, and randomized clinical trial. SETTING: Faculty of Medicine, University of São Paulo (USP); Sector of Biological Sciences - Physiotherapy Course, Federal University of Paraná (UFPR). METHODS: The study included 125 elderly people with chronic nonspecific low back pain who were randomized to one of 5 study groups: 3 of electroacupuncture; one control; and one placebo, all of them treated for 5 weeks. The primary endpoint was pain intensity, and secondary endpoints included the qualitative aspect of pain, functional disability (Roland-Morris and sit and stand test), emotional functioning (depression and anxiety), and psychosocial factors. Data analysis followed the intention-to-treat principle. The confidence interval was set at 95% and the significance level at 5%. RESULTS: All groups achieved a reduction in pain intensity; however, a significant difference was only detected between electroacupuncture and placebo, where the latter showed greater pain reduction. Regarding secondary outcomes, all groups showed good posttreatment results for all assessments but without statistical significance. Among the groups, the placebo was the one that obtained the best results between the pre- and post-treatment for depression, qualitative aspect of pain, and functional disability, but only for the qualitative aspect of pain and for the sit-and-stand test was a significant reduction found in the intergroup comparison. The analysis of the overall effect perceived by the participants in relation to low back pain revealed that individuals from all groups felt close to full recovery. LIMITATIONS: Absence of follow-up and a relatively small number of patients. CONCLUSIONS: This study provides evidence that there is no one frequency of electroacupuncture that is most effective in treating chronic low back pain in the elderly and that electroacupuncture is not superior to manual acupuncture or placebo treatment. KEY WORDS: Electroacupuncture, acupuncture, low back pain, aged, health of the elderly, rehabilitation, clinical trial, interdisciplinary research Clinical trials registration: NCT03802045 (January 2019).

Postpartum stress urinary incontinence (PSUI) is a common condition among women after childbirth. While acupuncture is a common clinical treatment for PSUI, high-quality clinical evidence supporting its effectiveness is currently lacking. This study aims to preliminarily evaluate the efficacy and safety of acupuncture for early postpartum stress urinary incontinence, providing reference data for sample size calculation and protocol feasibility in formal trials. This is a randomized controlled trial. Seventy-two PSUI patients between 42 days and 1 year postpartum will be randomly assigned in a 1:1 ratio to either the acupuncture group (n = 36) or the sham acupuncture group (n = 36). Both groups will receive acupuncture treatments three times per week for two weeks. Both groups will receive identical education regarding pelvic floor muscle training. The primary outcomes are changes in urine leakage volume measured by 1-hour pad test at week 2 of treatment and week 6 of follow-up compared to baseline (week -1), and the proportion of patients achieving at least 50% reduction in urine leakage volume at week 2 compared to baseline. Secondary outcomes include 72-hour bladder diary, The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF), Incontinence Quality of Life questionnaire (I-QOL), and pelvic floor muscle strength assessment. The results of this study will provide preliminary evidence on the efficacy and safety of acupuncture for PSUI, offering reference data for sample size calculation and protocol feasibility in formal trials, ultimately providing more treatment options for PSUI patients. ITMCTR2024000290.