Effectiveness of Acupuncture for Pain Control After Cesarean Delivery: A Randomized Clinical Trial.

IMPORTANCE: A pharmacological approach to pain control after cesarean delivery is often insufficient on its own. Acupuncture is a promising method for mitigating postoperative pain and reducing postoperative opioid requirements. OBJECTIVE: To evaluate the efficacy and effectiveness of acupuncture as an adjunctive therapy for pain control after cesarean delivery, compared with a placebo intervention and standard care alone. DESIGN, SETTING, AND PARTICIPANTS: This single-center, placebo-controlled, patient- and assessor-blinded randomized clinical trial was conducted from January 13, 2015, to June 27, 2018, at a tertiary university hospital in Greifswald, Germany. Participants were women who were scheduled for elective cesarean delivery under spinal anesthesia and were randomized to either the acupuncture group (n = 60) or placebo group (n = 60). Another 60 consecutive patients who met the eligibility criteria and received the standard postoperative analgesia were selected to form a nonrandomized standard care group. The intention-to-treat analysis was performed from August 19, 2019, to September 13, 2019. INTERVENTIONS: In addition to standard pain treatment, each patient in the acupuncture group received auricular and body acupuncture with indwelling intradermal needles, whereas patients in the placebo group were treated with nonpenetrating placebo needles. MAIN OUTCOMES AND MEASURES: The primary outcome was pain intensity on movement, which was measured using an 11-item verbal rating scale. Secondary outcomes were analgesia-related adverse effects, analgesics consumption, time to mobilization and Foley catheter removal, quality of patient blinding to randomization, and patient satisfaction with treatment of pain. RESULTS: A total of 180 female patients (mean [SD] age, 31 [5] years) were included in the intention-to-treat analysis. The mean pain intensity on movement in the acupuncture group on the first postoperative day was lower than in the placebo group (4.7 [1.8] vs 6.0 [2.0] points; Cohen d, 0.73; 95% CI, 0.31-1.01; P = .001) and the standard care group (6.3 [1.3] points; Cohen d, 1.01; 95% CI, 0.63-1.40; P < .001). On the first postoperative day, 59 patients (98%) in the acupuncture group were fully mobilized vs 49 patients (83%) in the placebo group (relative risk [RR], 1.18; 95% CI, 1.06-1.33; P = .01) and 35 patients (58%) in the standard care group (RR, 1.69; 95% CI, 1.36-2.09; P < .001). The Foley catheter was removed in a total of 57 patients (93%) from the acupuncture group vs 43 patients (72%) from the placebo group (RR, 1.33; 95% CI, 1.12-1.57; P = .003) and 42 patients (70%) from the standard care group (RR, 1.37; 95% CI, 1.14-1.62; P = .002). Other parameters were comparable across the 3 study groups. CONCLUSIONS AND RELEVANCE: Results of this trial showed that acupuncture was safe and effective in reducing pain and accelerating mobilization of patients after cesarean delivery. With consideration for personnel and time expenditures, acupuncture can be recommended as routine, supplemental therapy for pain control in patients after elective cesarean delivery. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02364167.

Auricular stimulation vs. expressive writing for exam anxiety in medical students - A randomized crossover investigation.

OBJECTIVE: Auricular stimulation (AS) is a promising method in the treatment of situational anxiety. Expressive writing (EW) is an established psychological method, which reduces test anxiety and improves exam results. The aim of this crossover trial was to compare AS with EW, and with the no intervention (NI) condition, for treatment of exam anxiety. METHODS: Healthy medical students underwent 3 comparable anatomy exams with an interval of one month, either performing EW, receiving AS or NI prior to the exam; the order of interventions was randomized. AS was applied using indwelling fixed needles bilaterally at the areas innervated mostly by the auricular branch of the vagal nerve on the day before the exam. Anxiety level, measured using State-Trait-Anxiety Inventory (STAI) before and after the interventions and immediately before exam, was the primary outcome. Quality of night sleep, blood pressure, heart rate and activity of salivary alpha-amylase (sAA) were analyzed across 3 conditions. RESULTS: All 37 included participants completed the study. Anxiety level (STAI) decreased immediately after AS in comparison with baseline (P = 0.02) and remained lower in comparison with that after EW and NI (P<0.01) on the day of exam. After EW and NI anxiety increased on the day of exam in comparison with baseline (P<0.01). Quality of sleep improved after AS in comparison with both control conditions (P<0.01). The activity of sAA decreased after EW and after AS (P<0.05) but not after NI condition. CONCLUSION: Auricular stimulation, but not expressive writing, reduced exam anxiety and improved quality of sleep in medical students. These changes might be due to reduced activity of the sympathetic nervous system.

Computerized 4-choice reaction time test for the measurement of psychomotor recovery after general anesthesia.

The recovery of patients after general anesthesia is usually estimated by using clinical scores. Since there is a lack of objective methods for assessing psychomotor recovery, the aim of this study was to evaluate three psychological tests for this purpose. Patients, scheduled for ambulatory gynecological surgery, underwent 3 standard psychological tests before (T1), 15 min after the surgery (T2) and on discharge from the recovery room (T3). The tests used were Wechsler memory scale (test 1, working memory capacity), d2-test (test 2, concentration endurance) and computer-based 4-choice-reaction time (4CRT, test 3, reaction time) as well as Postanesthesia Discharge Scoring System (PADSS). The same test battery was used in healthy female volunteers, all test results were compared at the different time points. In 109 patients, working memory capacity and concentration (tests 1 and 2) decreased, the reaction time (test 3) was prolonged at T2 in comparison with T1 and T3 (P < 0.01). PADSS increased from 8 (T2) to 10 (T3) (medians, P < 0.001). Fifty-seven healthy volunteers demonstrated a practice effect in all 3 tests through the course of the study (P <0.01). 4CRT test had shortest duration and enabled computerized data processing. All three tests objectively assess the recovery of psychomotor function in patients after general anesthesia, the computer-based 4CRT seems to be the most convenient for the clinical routine.

Auricular acupuncture for treatment of preoperative anxiety in patients scheduled for ambulatory gynaecological surgery: a prospective controlled investigation with a non-randomised arm.

OBJECTIVE: Auricular acupuncture (AA) is a promising alternative treatment for situational anxiety. The aim of this pilot investigation was to test the acceptability and feasibility of AA as a treatment for preoperative anxiety (PA) in preparation for a subsequent randomised controlled trial. METHODS: AA was offered for treatment of PA to female patients who were scheduled for ambulatory gynaecological surgery. In patients who agreed, indwelling fixed needles were applied bilaterally at the points MA-IC1, MA-TF1, MA-SC, MA-AH7 and MA-T the day before surgery. Patients who declined AA but agreed to be examined constituted the control group (no intervention). State anxiety (primary outcome) was measured using the State-Trait-Anxiety Inventory (STAI) before AA (time I), the evening before surgery (time II) and immediately before surgery (time III). Anxiety was measured with a 100 mm visual analogue scale (VAS-100); heart rate, blood pressure and serum cortisol were also quantified. RESULTS: Data from 62 patients (32 with AA and 30 with no intervention) were analysed. Whereas preoperative anxiety was reduced after AA the evening before surgery (P<0.01), anxiety levels in the control group increased from the first to the last measurement (P<0.001). Secondary outcomes were comparable between the patients from both groups. CONCLUSIONS: AA was acceptable and feasible as a treatment for preoperative anxiety. The results were used for the sample size calculation of a subsequent randomised controlled clinical trial. TRIAL REGISTRATION NUMBER: NCT02656966; Results.

Disparity between High Satisfaction and Severe Pain in Patients after Caesarean Section: A Prospective Observational-Controlled Investigation.

OBJECTIVES: Recent advances in the treatment of postoperative pain (POP) have increased the quality of life in surgical patients. The aim of this study was to examine the quality of POP management in patients after CS in comparison with patients after comparable surgical procedures. METHODS: This was a prospective observational analysis in patients after CS in comparison with the patients of the same age, who underwent comparable abdominal gynaecological surgeries (GS group) at the university hospital. A standardised questionnaire including pain intensity on the Verbal Rating Scale (VRS-11), incidence of analgesia-related side effects, and incidence of pain interference with the items of quality of life and patients' satisfaction with the treatment of POP was used. RESULTS: Sixty-four patients after CS reported more pain on movement than the patients after GS (N=63): mean 6.1 versus 3.6 (VRS-11; P < 0.001). The patients after CS reported less nausea (8 versus 41%) and vomiting (3 versus 21%; P < 0.001) and demonstrated better satisfaction with POP treatment than the patients after GS: 1.4 (0.7) versus 1.7 (0.7) (mean (SD); VRS-5; P=0.02). CONCLUSION: The disparity between the high level of pain and excellent satisfaction with POP treatment raises the ethical and biomedical considerations of restrictive pharmacological therapy of post-CS pain.

Auricular Acupuncture for Exam Anxiety in Medical Students-A Randomized Crossover Investigation.

Auricular acupuncture (AA) is effective in the treatment of preoperative anxiety. The aim was to investigate whether AA can reduce exam anxiety as compared to placebo and no intervention. Forty-four medical students were randomized to receive AA, placebo, or no intervention in a crossover manner and subsequently completed three comparable oral anatomy exams with an interval of 1 month between the exams/interventions. AA was applied using indwelling fixed needles bilaterally at points MA-IC1, MA-TF1, MA-SC, MA-AT1 and MA-TG one day prior to each exam. Placebo needles were used as control. Levels of anxiety were measured using a visual analogue scale before and after each intervention as well as before each exam. Additional measures included the State-Trait-Anxiety Inventory, duration of sleep at night, blood pressure, heart rate and the extent of participant blinding. All included participants finished the study. Anxiety levels were reduced after AA and placebo intervention compared to baseline and the no intervention condition (p < 0.003). AA was better at reducing anxiety than placebo in the evening before the exam (p = 0.018). Participants were able to distinguish between AA and placebo intervention. Both AA and placebo interventions reduced exam anxiety in medical students. The superiority of AA over placebo may be due to insufficient blinding of participants.

Auricular acupuncture for pre-exam anxiety in medical students: a prospective observational pilot investigation.

OBJECTIVE: Auricular acupuncture (AA) is effective for the treatment of preoperative anxiety. We aimed to study the feasibility and effects of AA on exam anxiety in a prospective observational pilot study. METHODS: Healthy medical students received bilateral AA using indwelling fixed needles at points MA-IC1, MA-TF1, MA-SC, MA-AH7, and MA-T on the day before an anatomy exam. The needles were removed after the exam. Anxiety levels were measured using the State-Trait-Anxiety Inventory (STAI) and a 100 mm visual analogue scale (VAS-100) before and after the AA intervention and once again immediately before the exam. The duration of sleep on the night before the exam was recorded and compared to that over the preceding 1 week and 6 months (all through students' recollection). In addition, blood pressure, heart rate and the acceptability of AA to the students were recorded. RESULTS: Ten students (all female) were included in the final analysis. All tolerated the needles well and stated they would wish to receive AA again for exam anxiety in the future. Exam anxiety measured using both STAI and VAS-100 decreased by almost 20% after AA. CONCLUSIONS: AA was well accepted, the outcome measurement was feasible, and the results have facilitated the calculation of the sample size for a subsequent randomised controlled trial.

Acupuncture for pain control after Caesarean section: a prospective observational pilot study.

OBJECTIVE: Options for pharmacological analgesia in patients who have undergone Caesarean section (CS) are often restricted. Acupuncture is a promising tool for treating postoperative pain. We aimed to study the feasibility and acceptability of acupuncture as an additional method of analgesia in CS patients in a prospective observational pilot investigation. METHODS: Twenty-two patients scheduled for elective CS under spinal anaesthesia were enrolled according to set inclusion criteria. Each patient received auricular and body acupuncture with 20 indwelling fixed needles according to previously validated protocols of acupuncture for postoperative analgesia. Pain intensity on an 11-point verbal rating scale (VRS-11, where 0=no pain and 10=maximal pain), analgesia-related side effects, time to mobilisation and Foley catheter removal after CS, and patients' compliance and satisfaction with treatment of pain on a 5-point VRS (VRS-5, where 1=excellent; 5=bad) were recorded. RESULTS: Twenty patients were included in the final analysis. One patient was disturbed by paraesthesia at the site of needling. All other patients tolerated acupuncture well. Pain intensity on movement on the first postoperative day was 4.3±2.4 (mean±SD; VRS-11) and decreased to 2.2±1.2 on the day of discharge. Patient satisfaction was 1.9±0.8 (mean±SD; VRS-5) and compliance (rated by their nurses) was 1.5±0.5 (mean±SD; VRS-5). CONCLUSIONS: Acupuncture for additional analgesia after CS was well accepted. The primary outcome measurement was feasible and allowed the sample size to be calculated for a future randomised controlled trial.

Morphological changes of the multifidus muscle in patients with symptomatic lumbar disc herniation.

OBJECT: Lumbar disc herniations are associated with segmental muscle alterations of the ipsilateral segmental multifidus muscle. The aim of the present study was a histopathological analysis of the myopathological changes of the multifidus muscle and correlation with the duration of radicular symptoms. METHODS: Multifidus muscle biopsies were performed in 20 patients during discectomy. Specimens were obtained from the area of the multifidus muscle innervated by the nerve from the level of the affected disc. Histopathological findings were classified according as neurogenic tissue syndrome and nonspecific myopathological syndrome, and these results were correlated with the duration of radicular symptoms. RESULTS: Results of multifidus muscle biopsies were classified as neurogenic tissue syndrome in 12 patients and as nonspecific myopathological syndrome in 8. The mean (+/- SD) duration of radicular symptoms was 10.75 +/- 7.9 months in patients with neurogenic tissue syndrome and 4.37 +/- 3.9 months in patients with a nonspecific myopathological syndrome. There was a positive correlation between group assignment and symptom duration (correlation coefficient 0.457, p = 0.043). CONCLUSIONS: A long duration of radicular symptoms is associated with a neurogenic tissue syndrome, whereas a nonspecific myopathological tissue syndrome is seen in patients with shorter duration of symptoms. This suggests that patients with long duration of radicular symptoms originating from a lumbar disc herniation have an increased risk for neurogenic muscular changes, and that consideration should be given to an earlier surgical intervention.

Clinical determinants of ventricular sympathetic reinnervation after orthotopic heart transplantation.

BACKGROUND: It has been demonstrated that ventricular sympathetic reinnervation after cardiac transplantation improves exercise performance. The extent of reinnervation increases with time but is variable. Little is known about other influencing factors. METHODS AND RESULTS: Seventy-seven nonrejecting transplant recipients were cross-sectionally studied by PET with the catecholamine analogue C-11 hydroxyephedrine at 4.8+/-3.5 years after transplantation. Results were compared with history-derived parameters related to recipient's clinical course before, during, and after surgery; donor characteristics; and immunogenetics. Partial reinnervation was observed in 52 patients (extent, 21+/-16% of left ventricle). Complete denervation was found in 25 patients at various times after transplantation. Reinnervation extent correlated with time after surgery (r=0.387; P<0.001) but also inversely with donor age (r=-0.309, P=0.006) and recipient age (r=-0.243, P=0.032). Maximal hydroxyephedrine retention correlated inversely with frequency of rejection episodes (r=-0.267, P=0.019), was reduced when aortic complications occurred perioperatively (9 patients), and correlated inversely with aortic cross-clamp time (r=-0.331, P=0.006). Other parameters were not associated with reinnervation. Patients were surveyed for clinical complications over >12 months after PET (until 7.3+/-4.2 years after transplantation), but significant effects of reinnervation on outcome were not observed. CONCLUSIONS: The present data suggest that sympathetic reinnervation after cardiac transplantation is not simply a function of time. Reinnervation is more likely with young age, fast and uncomplicated surgery, and low rejection frequency. Despite few effects on prognosis in otherwise healthy recipients, improved understanding of clinical determinants may contribute to enhance allograft reinnervation and thereby augment exercise capacity in the future.