Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial

Abstract

BackgroundMany pregnant women experience low back pain. Acupuncture appears to be a safe, promising intervention but evidence is needed about its clinical effectiveness and cost-effectiveness.ObjectivesTo assess the feasibility of a future large randomised controlled trial (RCT) testing the additional benefit of adding acupuncture to standard care (SC) for pregnancy-related back pain.DesignPhase 1: a questionnaire survey described current care for pregnancy-related back pain. Focus groups and interviews with midwives, physiotherapists and pregnant women explored acceptability and feasibility of acupuncture and the proposed RCT. Phase 2: a single-centre pilot RCT. Participants were identified using six methods and randomised to SC, SC plus true acupuncture or SC plus non-penetrating acupuncture.ParticipantsPhase 1: 1093 physiotherapists were surveyed and 15 midwives, 21 physiotherapists and 17 pregnant women participated in five focus groups and 20 individual interviews. Phase 2: 125 women with pregnancy-related back pain participated.InterventionsSC: a self-management booklet and onward referral for one-to-one physiotherapy (two to four sessions) for those who needed it. SC plus true acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising true (penetrating) acupuncture, advice and exercise. SC plus non-penetrating acupuncture: the self-management booklet and six to eight treatments with a physiotherapist comprising non-penetrating acupuncture, advice and exercise.Main outcome measuresPilot RCT outcomes included recruitment rates, treatment fidelity, follow-up rate, patient-reported pain and function, quality of life and health-care resource use. Birth and neonatal outcomes were also assessed. Staff overseeing outcome data collection were blind to treatment allocation.ResultsPhase 1: 629 (57.5%) physiotherapists responded to the survey, 499 were experienced in treating pregnancy-related back pain and reported 16 advice and 18 treatment options. Typical treatment comprised two to four individual sessions of advice and exercise over 6 weeks. Acupuncture was reported by 24%. Interviews highlighted the impact of back pain and paucity of effective interventions. Women and midwives strongly supported a RCT and expressed few concerns. Physiotherapists’ concerns about acupuncture in pregnancy informed a training programme prior to the pilot RCT. Phase 2: We recruited 125 of 280 potentially eligible women (45%) in 6 months and randomised 41 to SC and 42 each to the SC plus true acupuncture and SC plus non-penetrating acupuncture arms. Analysis was conducted with 124 participants (41, 42 and 41, respectively) as one participant was randomised in error. Three of six recruitment methods were the most successful. In total, 10% of women (n = 4) randomised to SC alone accessed one-to-one physiotherapy and received an average of two treatments. The average number of treatments was six for both SC plus true acupuncture and SC plus non-penetrating acupuncture. Treatments were in line with protocols. Eight-week follow-up was 74%. Patient-reported outcomes (pain, function and quality of life) favoured the addition of acupuncture. There was no evidence of serious adverse events on mothers or birth and neonatal outcomes. The Pelvic Girdle Questionnaire was found to be an appropriate outcome measure for a future trial.ConclusionsA future main RCT is feasible and would be welcomed by women and clinicians. Longer-term follow-up and further follow-up efforts are recommended for a main trial.Trial registrationCurrent Controlled Trials ISRCTN49955124.FundingThis project was funded by the National Institute of Health Research Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 33. See the NIHR Journals Library website for further project information.

Current management of pregnancy-related low back pain: a national cross-sectional survey of UK physiotherapists

“…Western/medical acupuncture is the predominant style of acupuncture used by UK physiotherapists, who use an average of seven acupuncture points per treatment session and aim to elicit the needle sensation of DeQi. The use of a variety of advice and treatment options for the patient described in the vignette is in keeping with previous studies of physiotherapeutic practice in other musculoskeletal conditions, where physiotherapists typically report employing packages of care comprising multiple treatment components [19,20]. Similarly, physiotherapists consider acupuncture as a single component within a package of care, rather than using it in isolation, and several previous studies of acupuncture have shown that it is typically used in combination with other treatment approaches, most often exercise [21].…”

“…The one area in which reported practice differed markedly between professional networks was in the reported use of acupuncture for the patient described in the vignette; respondents from AACP were more likely to report the use of acupuncture (44%) compared with respondents from MIMDTP (9%) and ACPWH (6%) [19].…”

Acupuncture – Basic Research and Clinical Application

“…To our knowledge, this is the first time that an explicit association between SE and kappa has been reported, although given that the former is a measure of response variability and the latter of agreement, the negative correlation between them would be expected. Indeed, SE-based measures of consensus and dissention for Likert scale data have been suggested before [70,71], although they do not appear to have been used except by their originators. For both datasets (NOW and THEN), a kappa value of 0.4 corresponds to SE of 1.02; thus, an intermediate or better value of kappa, using Fleiss's definitions, corresponds to a SE of 1.02 or less.…”

Evaluation of outpatient acupuncture for relief of pregnancy‐related conditions

“…Acupuncture is part of traditional Chinese medicine and is based on the stimulation of specific sites, known as acupuncture points, on the surface of the body. The most established method of acupuncture uses thin, solid, metallic needles for insertion into the skin, which are then manipulated either manually or by electrical stimulation . This technique is used for diagnostic and/or therapeutic purposes in reversible diseases or disorders that impact on the function of the patient .…”

“…The most established method of acupuncture uses thin, solid, metallic needles for insertion into the skin, which are then manipulated either manually or by electrical stimulation. 8 This technique is used for diagnostic and/or therapeutic purposes in reversible diseases or disorders that impact on the function of the patient. 9 Treatment usually comprises insertion of a varying number of needles (up to 30), which are removed after 20-30 minutes.…”