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Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial.

ABSTRACT: Acupuncture is commonly used to reduce pain during labour despite contradictory results. The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation (electro-acupuncture) compared with standard care in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care, and that electro-acupuncture was most effective.A longitudinal randomised controlled trial. The recruitment of participants took place at the admission to the labour ward between November 2008 and October 2011 at two Swedish hospitals . 303 nulliparous women with normal pregnancies were randomised to: 40 minutes of manual acupuncture (MA), electro-acupuncture (EA), or standard care without acupuncture (SC).labour pain, assessed by Visual Analogue Scale (VAS).relaxation, use of obstetric pain relief during labour and post-partum assessments of labour pain. The sample size calculation was based on the primary outcome and a difference of 15 mm on VAS was regarded as clinically relevant, this gave 101 in each group, including a total of 303 women.Mean estimated pain scores on VAS (SC: 69.0, MA: 66.4 and EA: 68.5), adjusted for: treatment, age, education, and time from baseline, with no interactions did not differ between the groups (SC vs MA: mean difference 2.6, 95% confidence interval [CI] -1.7-6.9 and SC vs EA: mean difference 0.6 [95% CI] -3.6-4.8). Fewer number of women in the EA group used epidural analgesia (46%) than women in the MA group (61%) and SC group (70%) (EA vs SC: odds ratio [OR] 0.35; [95% CI] 0.19-0.67).Acupuncture does not reduce women's experience of labour pain, neither with manual stimulation nor with combined manual and electrical stimulation. However, fewer women in the EA group used epidural analgesia thus indicating that the effect of acupuncture with electrical stimulation may be underestimated. These findings were obtained in a context with free access to other forms of pain relief.ClinicalTrials.gov: NCT01197950.

SUBMITTER: Vixner L

PROVIDER: S-EPMC4055800 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature

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Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial.

Vixner Linda L Schytt Erica E Stener-Victorin Elisabet E Waldenström Ulla U Pettersson Hans H Mårtensson Lena B LB

BMC complementary and alternative medicine 20140609

<h4>Background</h4>Acupuncture is commonly used to reduce pain during labour despite contradictory results. The aim of this study is to evaluate the effectiveness of acupuncture with manual stimulation and acupuncture with combined manual and electrical stimulation (electro-acupuncture) compared with standard care in reducing labour pain. Our hypothesis was that both acupuncture stimulation techniques were more effective than standard care, and that electro-acupuncture was most effective.<h4>Met ...[more]

PMID: 24913704

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Project description:BackgroundIn a previous randomised controlled trial we showed that acupuncture with a combination of manual- and electrical stimulation (EA) did not affect the level of pain, as compared with acupuncture with manual stimulation (MA) and standard care (SC), but reduced the need for other forms of pain relief, including epidural analgesia. To dismiss an under-treatment of pain in the trial, we did a long-term follow up on the recollection of labour pain and the birth experience comparing acupuncture with manual stimulation, acupuncture with combined electrical and manual stimulation with standard care. Our hypothesis was that despite the lower frequency of use of other pain relief, women who had received EA would make similar retrospective assessments of labour pain and the birth experience 2 months after birth as women who received standard care (SC) or acupuncture with manual stimulation (MA).MethodsSecondary analyses of data collected for a randomised controlled trial conducted at two delivery wards in Sweden. A total of 303 nulliparous women with normal pregnancies were randomised to: 40 min of MA or EA, or SC without acupuncture. Questionnaires were administered the day after partus and 2 months later.ResultsTwo months postpartum, the mean recalled pain on the visual analogue scale (SC: 70.1, MA: 69.3 and EA: 68.7) did not differ between the groups (SC vs MA: adjusted mean difference 0.8, 95% confidence interval [CI] -6.3 to 7.9 and SC vs EA: mean difference 1.3 CI 95% -5.5 to 8.1). Positive birth experience (SC: 54.3%, MA: 64.6% and EA: 61.0%) did not differ between the groups (SC vs MA: adjusted Odds Ratio [OR] 1.8, CI 95% 0.9 to 3.7 and SC vs EA: OR 1.4 CI 95% 0.7 to 2.6).ConclusionsDespite the lower use of other pain relief, women who received acupuncture with the combination of manual and electrical stimulation during labour made the same retrospective assessments of labour pain and birth experience 2 months postpartum as those who received acupuncture with manual stimulation or standard care.Trial registrationClinicalTrials.gov: NCT01197950.

Project description:BACKGROUND: Acupuncture is increasingly being used for many conditions including chronic neck pain. However the evidence remains inconclusive, indicating the need for further well-designed research. The aim of this study was to conduct a pilot randomised controlled parallel arm trial, to establish key features required for the design and implementation of a large-scale trial on acupuncture for chronic neck pain. METHODS: Patients whose GPs had diagnosed neck pain were recruited from one general practice, and randomised to receive usual GP care only, or acupuncture (up to 10 treatments over 3 months) as an adjunctive treatment to usual GP care. The primary outcome measure was the Northwick Park Neck Pain Questionnaire (NPQ) at 3 months. The primary analysis was to determine the sample size for the full scale study. RESULTS: Of the 227 patients with neck pain identified from the GP database, 28 (12.3%) consenting patients were eligible to participate in the pilot and 24 (10.5%) were recruited to the trial. Ten patients were randomised to acupuncture, receiving an average of eight treatments from one of four acupuncturists, and 14 were randomised to usual GP care alone. The sample size for the full scale trial was calculated from a clinically meaningful difference of 5% on the NPQ and, from this pilot, an adjusted standard deviation of 15.3%. Assuming 90% power at the 5% significance level, a sample size of 229 would be required in each arm in a large-scale trial when allowing for a loss to follow-up rate of 14%. In order to achieve this sample, one would need to identify patients from databases of GP practices with a total population of 230,000 patients, or approximately 15 GP practices roughly equal in size to the one involved in this study (i.e. 15,694 patients). CONCLUSION: This pilot study has allowed a number of recommendations to be made to facilitate the design of a large-scale trial, which in turn will help to clarify the existing evidence base on acupuncture for neck pain.

Project description:BackgroundTranscutaneous electrical nerve stimulation (TENS) involves a neuromodulatory effect using electrical stimulation and has been widely used due to its safety and convenience. It has been used for treating tinnitus for decades. Acupuncture has also been used for tinnitus and several research studies have shown that acupuncture can improve a certain kind of tinnitus by stimulating the somatosensory system. Moreover, several studies have shown the efficacy of electroacupuncture, which is a combination of acupuncture and electrical stimulation, for tinnitus. However, the comparative effectiveness of TENS, manual acupuncture, and electroacupuncture for the treatment of tinnitus has not been determined previously. Herein, we design a randomized, non-blind clinical trial to investigate and compare the effects and safety of TENS, manual acupuncture, and electroacupuncture for tinnitus.MethodsAfter screening, 45 patients are randomly assigned to three groups: (1) patients in the TENS group are treated at four sites (tender points of masseter and the sternocleidomastoid muscle, in front of tragus, and mastoid process); (2) the manual acupuncture group patients are treated at 11 acupoints (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of tinnitus affected side, and GB20, TE05, KI3 of both sides); (3) electroacupuncture group patients are treated by using acupuncture as in the manual acupuncture group and electrical stimulation at TE21, SI19, TE17, and GB20. Patients are treated for ten sessions, twice a week. The primary outcome measurement is the change of Tinnitus Handicap Inventory (THI) score between visit 1 and visit 10. The secondary outcome measurements are the response rate of THI, change in visual analogue scale associated with the loudness and annoyance of tinnitus, pure-tone audiometry and speech discrimination, and changes in parameters of heart rate variability.DiscussionThe purpose of this study is to compare the effect of TENS, manual acupuncture, and electroacupuncture in the auricular area on tinnitus. If the specific treatment shows a significant effect compared to other treatments, it could have potential for use in clinical practice as a primary treatment.Trial registrationClinical Research Information Service (CRIS), KCT0002117 . Registered October 21, 2016. Retrospectively registered.

Project description:ObjectiveTo investigate if there are differences between acupuncture and transcutaneous electrical nerve stimulation (TENS) as treatment for pelvic girdle pain (PGP) in pregnancy in order to manage pain and thus maintain health and functioning in daily activities and physical activity (PA).DesignRandomised controlled trial.Setting and participantsPregnant women (n=113) with clinically verified PGP in gestational weeks 12-28, recruited from maternity healthcare centres, randomised (1:1) into two groups.Exclusion criteriaany obstetrical complication, systemic disease or previous disorder that could contradict tests or treatment.InterventionsThe intervention consisted of either 10 acupuncture sessions (two sessions per week) provided by a physiotherapist or daily home-based TENS during 5 weeks.Primary outcome variablesDisability (Oswestry Disability Index), functioning (Patient Specific Functional Scale), work ability (Work Ability Index) and PA-level according to general recommendations.Secondary outcome variablesFunctioning related to PGP (Pelvic Girdle Questionnaire), evening pain intensity (Numeric Rating Scale, NRS), concern about pain (NRS), health (EuroQoL 5-dimension), symptoms of depression/catastrophising (Edinburgh Postnatal Depression Scale/Coping Strategies Questionnaire).ResultsNo mean differences were detected between the groups. Both groups managed to preserve their functioning and PA level at follow-up. This may be due to significantly (p<0.05) reduced within groups evening pain intensity; acupuncture -0.96 (95% CI -1.91 to -0.01; p=0.049), TENS -1.29 (95% CI -2.13 to -0.44; p=0.003) and concern about pain; acupuncture -1.44 (95% CI -2.31 to -0.57; p=0.0012), TENS -1.99 (95% CI -2.81 to -1.17; p<0.0001). The acupuncture group showed an improvement in functioning at follow-up; 0.82 (95% CI 0.01 to 1.63; p=0.048) CONCLUSION: Treating PGP with acupuncture or TENS resulted in maintenance of functioning and physical activity and also less pain and concern about pain. Either intervention could be recommended as a non-pharmacological alternative for pain relief and may enable pregnant women to stay active.Trial registration number12726. https://www.researchweb.org/is/sverige/project/127261.

Project description:IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023.

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Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial.

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Acupuncture with manual and electrical stimulation for labour pain: a longitudinal randomised controlled trial.

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