Time-effective analgesic effect of acupressure ankle strip pressing wrist and ankle acupuncture point on primary dysmenorrhea: Study protocol clinical trial (SPIRIT compliant).

BACKGROUND: Dysmenorrhea seriously affects the ability of women to perform normal social activities and decreases their quality of life. Primary dysmenorrhea can be effectively treated with acupuncture. Based on the wrist-ankle acupuncture (WAA) theory, we designed a portable WAA point compression treatment strap that treats diseases by automatically applying pressure to acupuncture points. The proposed study aims to evaluate the immediate analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. METHODS: The study will be a randomized controlled trial conducted from May 1, 2019 to May 30, 2020 that includes 78 students from Shanghai University of Traditional Chinese Medicine who have primary dysmenorrhea and meet the eligibility criteria. Participants will be randomly divided into 2 groups in a 1:1 allocation ratio. The intervention group will use the acupressure wrist-ankle strap equipped with tip compression component parts on the internal side; the control group will use the nonacupressure wrist-ankle strap with the tip compression parts removed. All participants will be treated for 30 minutes on the 1st day of menstruation. The primary outcome is the pain intensity score measured by the visual analog scale. The secondary outcomes are the onset time of analgesia, the pain threshold at Yinlingquan (SP 9), skin temperature at Guanyuan (CV 4), and expectations and satisfaction of patients as investigated via the expectation and treatment credibility scale. DISCUSSION: This trial will be the 1st study to evaluate the analgesic effect of the acupressure wrist-ankle strap in patients with primary dysmenorrhea. The quality of this study is ensured by the randomization, nonacupressure control, and blinded design. The results may provide evidence for a potential alternative treatment for primary dysmenorrhea and evidence-based proof of the analgesic effect of WAA.

Use of pharmacological and non-pharmacological labour pain management techniques and their relationship to maternal and infant birth outcomes: examination of a nationally representative sample of 1835 pregnant women.

AIM: women use various labour pain management techniques during birth. The objective of this study is to investigate women׳s use of pharmacological and non-pharmacological labour pain management techniques in relation to birth outcomes. METHODS: a sub-survey of a nationally representative sample of pregnant women (n=1835) from the Australian Longitudinal Study on Women׳s Health. RESULTS: our analysis identified women׳s use of water for labour pain management as decreasing the likelihood of their baby being admitted to special care nursery (OR=0.42, p<0.004) whereas the use of epidural increased this likelihood (OR=3.38, p<0.001) as well as for instrumental childbirth (OR=7.27, p<0.001). Epidural and pethidine use decreased women׳s likelihood of continuing breast-feeding (ORs=0.68 and 0.59, respectively, both p<0.01) whereas the use of breathing techniques and massage for pain control increased the likelihood of women continuing breast-feeding (ORs=1.72 and 1.62, respectively, both p<0.01). CONCLUSIONS: our study illustrates associations between the use of both pharmacological and non-pharmacological labour pain management techniques and selected birth outcomes while controlling for confounding variables. There remain significant gaps in the evidence base for the use of non-pharmacological labour pain control methods and our findings provide a platform with which to develop a broad clinical research programme around this topic.

Farmacopuntura con tramadol como analgesia posoperatoria preventiva en la herniorrafia inguinal / Pharmacopuncture with tramadol as preventive postoperative analgesia in inguinal herniorrhaphy

INTRODUCCIÓN: estudios demuestran que más del 40 % de los pacientes sufren dolor en el posoperatorio inmediato, y tres de cada cuatro lo experimentan los dos primeros días. OBJETIVO: evaluar la efectividad de la farmacopuntura con tramadol en la prevención del dolor posoperatorio en pacientes operados de hernia inguinal. MÉTODOS: estudio prospectivo, descriptivo, aleatorio y controlado a 60 pacientes operados de manera electiva de herniorrafia inguinal en el Hospital Militar Central "Dr. Carlos J. Finlay" en el período de septiembre de 2010 a septiembre de 2011. Se conformaron dos grupos de igual cantidad de pacientes: grupo F (estudio) en el que se aplicó farmacopuntura con tramadol 12,5 mg en los puntos del meridiano de estómago (E36, E44) y anestesia regional subaracnoidea, y el grupo C (control) en el que se empleó tramadol 100 mg por vía intramuscular e igual método anestésico. Se evaluó el dolor posoperatorio, según criterios del paciente por ubicación en la escala análoga visual. RESULTADOS: predominó el sexo masculino y el rango de más de 60 años de edad. Los pacientes que recibieron el método de anestesia-analgesia y farmacopuntura presentaron mayor grado de analgesia posoperatoria con ausencia completa de dolor en 60 %, con menor cantidad de náuseas y vómitos posoperatorios y una excelente estabilidad hemodinámica. CONCLUSIONES: la farmacopuntura con tramadol constituye un método terapéutico analgésico en la prevención del dolor posoperatorio.

INTRODUCTION: studies have shown that over 40 % of patients suffer from pain in the immediate postoperative period, and three out of every four during the first two days. OBJECTIVE: evaluate the effectiveness of pharmacopuncture with tramadol to prevent postoperative pain in patients undergoing surgery for inguinal hernia. METHODS: a prospective descriptive randomized controlled study was conducted of 60 patients electively operated on for inguinal hernia at Dr. Carlos J. Finlay Central Military Hospital from September 2010 to September 2011. Patients were divided into two equal groups: Group F (study) received pharmacopuncture with tramadol 12.5 mg at stomach meridian acupoints (E36, E44) and regional subarachnoid anaesthesia, and Group C (control) received intramuscular tramadol 100 mg and the same anaesthetic procedure. Postoperative pain was ranked on the visual analog scale based on criteria provided by patients. RESULTS: there was a predominance of the male sex and the over-60 age group. Patients receiving anaesthesia-analgesia and pharmacopuncture showed greater postoperative analgesia, with total absence of pain in 60 %, less postoperative nausea and vomiting, and excellent hemodynamic stability. CONCLUSIONS: pharmacopuncture with tramadol constitutes an analgesic therapeutic method to prevent postoperative pain.

Effects of motion style acupuncture treatment in acute low back pain patients with severe disability: a multicenter, randomized, controlled, comparative effectiveness trial.

Reviews of the efficacy of acupuncture as a treatment for acute low back pain (aLBP) have shown that there is insufficient evidence for its effect and that more research is needed. Motion style acupuncture treatment (MSAT) is novel in that it requires a part of the patient's body to move passively or actively while acupuncture needles are retained. A multicenter, randomized, comparative effectiveness trial was conducted to evaluate the effects of MSAT in aLBP with severe disability. A total of 58 aLBP patients with severe functional disability (defined per Oswestry Disability Index [ODI] ⩾60%) were recruited and assigned randomly to receive 1 session of either conventional diclofenac injection (n=29) or MSAT (n=29). The primary outcome measured improvement in LBP using the 10-point numerical rating scale of LBP, and the secondary outcome assessed disability using the Oswestry Disability Index at 30minutes and at 2, 4, and 24weeks after treatment. Analyses were by intention to treat. The numerical rating scale of the MSAT group decreased 3.12 (95% confidence interval=2.26, 3.98; P<.0001) more than that of the injection group and the Oswestry Disability Index of the MSAT group decreased 32.95% (95% confidence interval=26.88, 39.03; P<.0001) more than that of the injection group, respectively. The difference between the 2 groups maintained statistical significance at 2 and 4weeks after treatment. These results suggest that MSAT has positive effects on immediate pain relief and the functional recovery of aLBP patients with severe disability.

Is the operative delivery rate in low-risk women dependent on the level of birth care? A randomised controlled trial.

OBJECTIVE: To investigate possible differences in operative delivery rate among low-risk women, randomised to an alongside midwifery-led unit or to standard obstetric units within the same hospital. DESIGN: Randomised controlled trial. SETTING: Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Tromsø, Norway. POPULATION: A total of 1111 women assessed to be at low risk at onset of spontaneous labour. METHODS: Randomisation into one of three birth units: the special unit; the normal unit; or the midwife-led unit. MAIN OUTCOME MEASURES: Total operative delivery rate, augmentation, pain relief, postpartum haemorrhage, sphincter injuries and intrapartum transfer, Apgar score <7 at 5 minutes, metabolic acidosis and transfer to neonatal intensive care unit. RESULTS: There were no significant differences in total operative deliveries between the three units: 16.3% in the midwife-led unit; 18.0% in the normal unit; and 18.8% in the special unit. There were no significant differences in postpartum haemorrhage, sphincter injuries or in neonatal outcomes. There were statistically significant differences in augmentation (midwife-led unit versus normal unit RR 0.73, 95% CI 0.59-0.89; midwife-led unit versus special unit RR 0.69, 95% CI 0.56-0.86), in epidural analgesia (midwife-led unit versus normal unit RR 0.68, 95% CI 0.52-0.90; midwife-led unit versus special unit RR 0.64, 95% CI 0.47-0.86) and in acupuncture (midwife-led unit versus normal unit RR 1.45, 95% CI 1.25-1.69; midwife-led unit versus special unit RR 1.45, 95% CI 1.22-1.73). CONCLUSIONS: The level of birth care does not significantly affect the rate of operative deliveries in low-risk women without any expressed preference for level of birth care.

Pain management by primary care physicians, pain physicians, chiropractors, and acupuncturists: a national survey.

OBJECTIVES: Chronic pain is a serious public health problem and is treated by diverse health care providers. In order to enhance policies and programs to improve pain care, we collected information about the distribution of pain patients among four major groups of pain management providers: primary care physicians (PCPs), pain physicians, chiropractors, and acupuncturists, and the variation in the attitudes and practices of these providers with respect to some common strategies used for pain. METHODS: National mail survey of PCPs, pain physicians, chiropractors, and acupuncturists (ntotal = 3,000). RESULTS: Eight hundred seventeen responses were usable (response rate, 29%). Analyses weighted to obtain nationally representative data showed that PCPs treat approximately 52% of chronic pain patients, pain physicians treat 2%, chiropractors treat 40%, and acupuncturists treat 7%. Of the chronic pain patients seen for evaluation, the percentages subsequently treated on an ongoing basis range from 51% (PCPs) to 63% (pain physicians). Pain physicians prescribe long-acting opioids such as methadone, antidepressants or anti-convulsants, and other nontraditional analgesics approximately 50-100% more often than PCPs. Twenty-nine percent of PCPs and 16% of pain physicians reported prescribing opioids less often than they deem appropriate because of regulatory oversight concerns. Of the four groups, PCPs are least likely to feel confident in their ability to manage musculoskeletal pain and neuropathic pain, and are least likely to favor mandatory pain education for all PCPs. CONCLUSIONS: There is substantial variation in attitudes and practices of the various disciplines that treat chronic pain. This information may be useful in interpreting differences in patient access to pain care, planning studies to clarify patient outcomes in relation to different providers and treatment strategies, and designing a system that matches chronic pain patients to appropriate practitioners and treatments.

The visual analogue WOMAC 3.0 scale--internal validity and responsiveness of the VAS version.

BACKGROUND: Many people suffer with Osteoarthritis (OA) and subsequent morbidity. Therefore, measuring outcome associated with OA is important. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) has been a widely used patient reported outcome in OA. However, there is relatively little evidence to support the use of the Visual Analogue Scale (VAS) version of the scale. We aimed to explore the internal validity and responsiveness of this VAS version of the WOMAC. METHODS: Patients with chronic hip or knee pain of mechanical origin, waiting for a hip or knee joint replacement completed the WOMAC as part of a study to investigate the effects of acupuncture and placebo controls. Validity was tested using factor analysis and Rasch analysis, and responsiveness using standardised response means. RESULTS: Two hundred and twenty one patients (mean age 66.8, SD 8.29, 58% female) were recruited. Factor and Rasch analysis confirmed unidimensional Pain and Physical Functioning scales, capable of transformation to interval scaling and invariant over time. Some Differential Item Functioning (DIF) was observed, but this cancelled out at the test level. The Stiffness scale fitted the Rasch model but adjustments for DIF could not be made due to the shortness of the scale. Using the interval transformed data, Standardised Response Means were smaller than when using the raw, ordinal data. CONCLUSIONS: The WOMAC Pain and Physical Functioning subscales satisfied unidimensionality and ordinal scaling tests, and the ability to transform to an interval scale. Some Differential Item Functioning was observed, but this cancelled out at the test level and, by doing so, at the same time removed the disturbance of unidimensionality. The scaling characteristics of sets of items which use VAS require further analysis, as it would appear that they can lead to spurious levels of responsiveness and scale compression because they exaggerate the distortion of the ordinal scale. TRIAL NUMBER: UKCRN study ID: 4881 ISRCTN78434638.

Acupuncture for treating acute attacks of migraine: a randomized controlled trial.

OBJECTIVE: To discuss the results of a multicenter randomized controlled trial of the efficacy of verum acupuncture in treating acute migraine attacks. BACKGROUND: Acupuncture has been used in China for centuries to treat migraine headache. Convincing evidence of its efficacy in alleviating pain, however, has been inadequate to date. METHODS: A total of 218 patients with migraine were recruited for the study; 180 met the inclusion criteria; 175 completed the callback process and were randomized into 3 groups. One group received verum acupuncture while subjects in the other 2 groups were treated with sham acupuncture. Each patient received 1 session of treatment and was observed over a period of 24 hours. The main outcome measure was the differences in visual analog scale (VAS) scores before treatment and 0.5, 1, 2, and 4 hours after treatment. RESULTS: Significant decreases in VAS scores from baseline were observed in the fourth hour after treatment when VAS was measured in the patients who received either verum acupuncture or sham acupunctures (P < .05). The VAS scores in the fourth hour after treatment decreased by a median of 1.0 cm, 0.5 cm, and 0.1 cm in the verum acupuncture group, sham acupuncture group 1, and sham acupuncture group 2, respectively. Similarly, there was a significant difference in the change in VAS scores from baseline in the second hour after treatment among the 3 groups (P = .006). Moreover, at the second hour after treatment, only patients treated with verum acupuncture showed significant decreases in VAS scores from baseline by a median of 0.7 cm (P < .001). Significant differences were observed in pain relief, relapse, or aggravation within 24 hours after treatment as well as in the general evaluations among the 3 groups (P < .05). Most patients in the acupuncture group experienced complete pain relief (40.7%) and did not experience recurrence or intensification of pain (79.6%). CONCLUSION: Verum acupuncture treatment is more effective than sham acupuncture based on either Chinese or Western nonacupoints in reducing the discomfort of acute migraine. Verum acupuncture is also clearly effective in relieving pain and preventing migraine relapse or aggravation. These findings support the contention that there are specific physiological effects that distinguish genuine acupoints from nonacupoints.

Bee venom acupuncture for musculoskeletal pain: a review.

UNLABELLED: Bee venom (BV) acupuncture (BVA) involves injecting diluted BV into acupoints and is used for arthritis, pain, and rheumatoid diseases. The objective of this systematic review was to evaluate the evidence for the effectiveness of BVA in the treatment of musculoskeletal pain. Seventeen electronic databases were systematically searched up to September 2007 with no language restrictions. All randomized clinical trials (RCTs) of BVA for patients with musculoskeletal pain were considered for inclusion if they included placebo controls or were controlled against a comparator intervention. Methodology quality was assessed and, where possible, statistical pooling of data was performed. A total of 626 possibly relevant articles were identified, of which 11 RCTs met our inclusion criteria. Four RCTs that tested the effects of BVA plus classic acupuncture compared with saline injection plus classic acupuncture were included in the main meta-analysis. Pain was significantly lower with BVA plus classic acupuncture than with saline injection plus classic acupuncture (weighted mean difference: 100-mm visual analog scale, 14.0 mm, 95% CI = 9.5-18.6, P < .001, n = 112; heterogeneity: tau(2) = 0, chi(2) = 1.92, P = .59, I(2) = 0%). Our results provide suggestive evidence for the effectiveness of BVA in treating musculoskeletal pain. However, the total number of RCTs included in the analysis and the total sample size were too small to draw definitive conclusions. Future RCTs should assess larger patient samples for longer treatment periods and include appropriate controls. PERSPECTIVE: Bee venom acupuncture involves injecting diluted BV into acupoints and is used for arthritis, pain, and rheumatoid diseases. A meta-analysis produced suggestive evidence for the effectiveness of BVA in musculoskeletal pain management. However, primary data were scarce. Future RCTs should assess larger patient samples for longer treatment periods and include appropriate controls.

Acupuncture in migraine prevention: a randomized sham controlled study with 6-months posttreatment follow-up.

OBJECTIVE: To assess the efficacy of acupuncture in migraine prophylaxis. METHODS: Thirty-seven patients with migraine were enrolled in a randomized control trial at the Headache clinic located in a University Hospital. Real and sham acupuncture groups received 16 acupuncture sessions over 3 months. Treatment was individualized in the real acupuncture group and minimal acupuncture was used in the sham group. The primary end point was the percentage of patients with a >or=50% reduction in their migraine attack frequency in the second, third, fourth, fifth, and sixth (months) compared with the first one (baseline period). Primary and secondary end points were measured comparing headache diaries. RESULTS: Real acupuncture group showed improvement with significant differences compared with the sham acupuncture group in the primary efficacy end point (P=0.021) at the second month of the treatment. Differences also appeared in 2 secondary end points: number of days with migraine per month (P=0.007) in the second month and the percentage of patients with >or=40% reduction in migraine attack frequency in the first (P=0.044) and second months (P=0.004) of the treatment. These differences disappeared in the third (last) month of the treatment as a consequence of the high improvement of the sham acupuncture group. Comparisons within each group showed that several migraine parameters evaluated improved significantly in both groups. CONCLUSIONS: Individualized treatment based on traditional Chinese medicine plays a role in preventing migraine attacks. Nevertheless, sham acupuncture had similar effects. Major conclusions were limited by the small sample sizes however the observed trends may contribute to design future trials.

Acupuncture in migraine: investigation of autonomic effects.

OBJECTIVE: A dysregulation of the autonomic nervous system is discussed as a pathogenetic factor in migraine. As acupuncture has been shown to exhibit considerable autonomic effects, we tested whether the clinical effects of acupuncture in migraine prophylaxis are mediated by changes of the autonomic regulation. METHODS: We simultaneously monitored changes of heart-rate variability (HRV) as an index of cardiac autonomic control and clinical improvement during an acupuncture treatment in 30 migraineurs. HRV was derived from spectral analysis of the electrocardiogram, which was performed before, during, and after the first and the last session of a series of 12 acupuncture sessions. Migraineurs were randomly allocated to 2 groups receiving either verum acupuncture (VA) or sham acupuncture (SA) treatment. RESULTS: Across the combined VA and SA groups, the clinical responders (with at least 50% reduction of migraine attacks) exhibited a decrease of the low-frequency (LF) power of HRV in the course of the treatment, which was not be observed in patients without clinical benefit. VA compared with SA induced a stronger decrease of high-frequency power. The mode of acupuncture, however, did not have an impact on the LF component of HRV or the clinical outcome. DISCUSSION: The data indicate, that VA and SA acupuncture might have a beneficial influence on the autonomic nervous system in migraineurs with a reduction of the LF power of HRV related to the clinical effect. This might be due to a reduction of sympathetic nerve activity. VA and SA induce different effects on the high-frequency component of HRV, which seem, however, not to be relevant for the clinical outcome in migraine.

Acupuncture treatment improves nerve conduction in peripheral neuropathy.

The etiology of peripheral neuropathy (PN) often remains elusive resulting in a lack of objective therapeutic strategies. We conducted a pilot study to evaluate the therapeutic effect of acupuncture on PN as measured by changes in nerve conduction and assessment of subjective symptoms. One hundred and ninety-two consecutive patients with PN as diagnosed by nerve conduction studies (NCS) were evaluated over a period of 1 year. Of 47 patients who met the criteria for PN of undefined etiology, 21 patients received acupuncture therapy according to classical Chinese Medicine as defined by the Heidelberg Model, while 26 patients received the best medical care but no specific treatment for PN. Sixteen patients (76%) in the acupuncture group improved symptomatically and objectively as measured by NCS, while only four patients in the control group (15%) did so. Three patients in the acupuncture group (14%) showed no change and two patients an aggravation (10%), whereas in the control group seven showed no change (27%) and 15 an aggravation (58%). Importantly, subjective improvement was fully correlated with improvement in NCS in both groups. The data suggest that there is a positive effect of acupuncture on PN of undefined etiology as measured by objective parameters.

Comparison of clinical and evoked pain measures in fibromyalgia.

UNLABELLED: Evoked pain measures such as tender point count and dolorimetry are often used to determine tenderness in studies of fibromyalgia (FM). However, these measures frequently do not improve in clinical trials and are known to be influenced by factors other than pain such as distress and expectancy. The purpose of this investigation was to determine whether evoked pain paradigms that present pressure stimuli in a random fashion (eg, Multiple Random Staircase [MRS]) would track with clinical pain improvement in patients with FM better than traditional measures. Sixty-five subjects enrolled in a randomized clinical trial of acupuncture were observed longitudinally. Clinical pain was measured on a 101-point numerical rating scale (NRS) and the Short Form McGill Pain Questionnaire (SF-MPQ), whereas evoked pressure sensitivity was assessed via manual tender point count, dolorimetry, and MRS methods. Improvements in clinical pain and evoked pain were assessed irrespective of group assignment. Improvement was seen in clinical pain during the course of the trial as measured by both NRS (P = .032) and SF-MPQ (P = .001). The MRS was the only evoked pain measure to improve correspondingly with treatment (MRS, P = .001; tender point count and dolorimeter, P > .05). MRS change scores were correlated with changes in NRS pain ratings (P = .003); however, this association was not stronger than tender point or dolorimetry correlations with clinical pain improvement (P > .05). Pain sensitivity as assessed by random paradigms was associated with improvements in clinical FM pain. Sophisticated pain testing paradigms might be responsive to change in clinical trials. PERSPECTIVE: Trials in fibromyalgia often use both clinical and experimental methods of pain assessment; however, these two outcomes are often poorly correlated. We explore the relationship between changes in clinical and experimental pain within FM patients. Pressure pain testing that applies stimuli in a random order is associated with improvements in clinical pain, but this association was not stronger than other experimental techniques.

Acupuncture use for the treatment of headache prior to neurological referral.

Acupuncture is a popular complementary treatment for various pain syndromes. Some studies claim efficacy in the treatment of primary headache syndromes. However, data on the frequency of acupuncture use by patients with headache prior to neurological referral have not been identified. In this study, 12% of patients with headache attending general neurology outpatient clinics had already received acupuncture; of the remainder, 73% said they would be willing to try it.