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Foster NE, Bishop A, Bartlam B, et al. Evaluating Acupuncture and Standard carE for pregnant women with Back pain (EASE Back): a feasibility study and pilot randomised trial. Southampton (UK): NIHR Journals Library; 2016 Apr. (Health Technology Assessment, No. 20.33.)

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

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Chapter 2Phase 1 pre-pilot work

Objectives of phase 1 pre-pilot work

The specific objectives of phase 1 were to:

  • provide data on current UK SC and acupuncture treatment for low back pain in pregnant women
  • explore the views of pregnant women with back pain about the acceptability of the proposed interventions, the content and delivery of participant information, the outcomes most important to them and the most appropriate timing of outcome measurement
  • optimise trial information, recruitment and consent procedures by learning what works best from the perspectives of pregnant women with low back pain, midwives and physiotherapists
  • investigate the views of NHS health professionals regarding (1) the acceptability and feasibility of referring women with back pain in pregnancy to physiotherapists for acupuncture, (2) the proposed trial design and interventions and (3) ways in which to maximise recruitment and retention to a trial.

In order to address the above objectives, we used mixed research methods of a descriptive survey and qualitative interviews. Findings from the survey informed the semistructured interview schedule, and findings from both methods were integrated at the analysis stage to give additional validation.46 The pre-pilot work in phase 1 was reviewed and approved by National Research Ethics Service Committee North West – Greater Manchester North (ref. 12/NW/0227).

National survey of chartered physiotherapists

Methods

Design and setting

This was a national cross-sectional survey of national samples of physiotherapists working in the UK from June to July 2012. Consent of respondents was assumed if they completed and returned the questionnaire; therefore, written consent was not sought from each participant.

Survey sample and mailing

The inclusion criteria were physiotherapists who:

  • were members of the Chartered Society of Physiotherapy
  • had experience of treating women with pregnancy-related low back pain.

We randomly sampled from three professional networks of the Chartered Society of Physiotherapy. Although the optimal approach to generate representative survey findings is to use a simple random sample, there is no comprehensive sampling frame for all UK-based physiotherapists available at the current time. The professional networks selected were those with interests relevant to low back pain, acupuncture and pregnancy/women’s health, with a total combined membership of around 7000 physiotherapists. This large sampling frame was required to access physiotherapists with a range of experience and clinical interests, to result in as generalisable a data set as possible about physiotherapy care for pregnancy-related back pain across the UK. The Chartered Society of Physiotherapy is the predominant professional trade union and educational body for physiotherapists in the UK and has 30 affiliated professional networks, usually with a specific clinical or occupational interest, which members have the option of joining. It was not possible to target only those physiotherapists working in the NHS. Random samples of members of the three professional networks (total n = 1093) were mailed by the administrators of each network and two reminder mailings were subsequently sent to non-responders. The professional networks were chosen to include physiotherapists with a special interest in (1) women’s health (ACPWH), (2) acupuncture (the Acupuncture Association of Chartered Physiotherapists) and (3) musculoskeletal pain conditions (McKenzie Institute of Mechanical Diagnosis and Therapy Practitioners). An initial filter question identified those respondents who had never treated a pregnant woman with low back pain in pregnancy, and only respondents with experience of treating this patient group were included in the analysis.

As the aim of this survey was primarily descriptive, a formal sample size calculation was not carried out. Previous surveys of physiotherapists in the UK indicated a likely response rate of 55–60%47–49 and so we expected approximately 600–650 overall responses from the mailing of 1093. This sample size is sufficient to estimate the proportions of the key survey variables within less than a 5% margin of error with 95% confidence.

Survey questionnaire

A previous national survey questionnaire of physiotherapy practice for non-specific low back pain (not related to pregnancy) was adapted for use in this study.48 The questionnaire captured information about respondents’ demographics and clinical practice including years in practice, practice setting, postgraduate training in musculoskeletal pain, women’s health and acupuncture as well as experience of managing women with pregnancy-related back pain. The questionnaire investigated current clinical care using a patient vignette of a specific, typical case developed from a real patient example following recommendations from other studies50–52 and was pilot tested with 18 physiotherapists. The patient vignette is reproduced below, whereas the full questionnaire is provided in Appendix 1. Respondents were asked how they would manage this woman, including likely treatment approaches, advice offered and number of treatment sessions provided. Specific questions on their use of acupuncture were also included.

We additionally asked the physiotherapists whether or not they routinely used specific advice or self-management leaflets in the management of pregnancy-related low back pain and PGP and, if so, to enclose a copy of the leaflet in their response to the survey. This resulted in the research team receiving examples of 37 different advice and self-management leaflets currently used by physiotherapists. These were used to help develop the self-management booklet used in the pilot RCT in phase 2 of the EASE Back study (see The development of a standard care protocol).

The patient vignette of a typical patient

A 34-year-old woman was referred from her GP with symptoms of intermittent sharp pain at her lower thoracic and lumbar regions and reports that the symptoms began a few weeks ago. She is 24 weeks pregnant with her first child. She is in good general health and of normal weight for her height and has never had back pain before.

Her back pain presents as occasional sharp sensations at the lumbar/lower thoracic regions of her spine and seems to be unrelated to posture or activity. She also has some dull pain in the lower back region, which is more persistent but of lesser intensity than the sharp pain she occasionally experiences. Her symptoms are worse if she maintains a sitting posture for prolonged periods. She is reluctant to use any analgesic medication because of her pregnancy.

Upon examination there is no exacerbation with movement or any directional preference. She has normal range of movement and is moderately tender on the paraspinal muscles of her lower back. Straight-leg raise and slump tests are negative.

Statistical analysis

Analysis was primarily descriptive, using summary statistics to describe physiotherapists’ characteristics and provide data on current practice, including SC and their use of acupuncture. As treatment has been shown to differ across practice settings,53 treatment approaches used by respondents working in NHS and non-NHS settings were compared using Pearson’s chi-squared tests. This survey was not designed to test for differences between members of different professional networks. However, as the survey sample was not a simple random sample of physiotherapists in the UK, some exploratory comparisons between the professional networks were undertaken to explore any internetwork differences. All analyses were performed using Stata version 13 (StataCorp LP, College Station, TX, USA).

Results

Response rate and characteristics of responders

Responses were received from 629 (58%) of those mailed. Of these, 499 had treated at least one woman with pregnancy-related low back pain and were included in the analysis. The demographic and practice characteristics of the respondents are presented in Table 1. The respondents were very experienced (mean of 22 years in practice) and most were female. Respondents worked in a variety of settings: NHS only, non-NHS only or a combination of practice settings. Referrals of women with pregnancy-related back pain were received by respondents from a variety of other health-care practitioners and self-referral to physiotherapy by women themselves was also commonly reported. Approximately one-third of respondents reported seeing a pregnant woman with back pain at least once a month.

TABLE 1. Demographic and practice characteristics of physiotherapists.

TABLE 1

Demographic and practice characteristics of physiotherapists. Values are frequencies and percentages unless specified as mean and SD

Standard care management

Standard care was explored by asking respondents to indicate the management options they would use for the typical patient described in the vignette. Most respondents (88%, n = 430) reported that they would be responsible for the care of such a patient, but 12% (n = 58) reported it was not their role and that this type of patient would be specifically referred to a women’s health specialist physiotherapist. A large majority of respondents (85%, n = 364) reported that they would manage this patient in one-to-one treatment sessions. The remainder reported that they would manage this patient as part of a group or class and that they would use one-to-one sessions for initial patient assessment only or only if required. This typical patient would be seen three or four times over a period of 3–6 weeks, although the episode would be left open for the duration of the pregnancy so that a woman could reconsult the physiotherapist if needed until after the birth of her baby. Table 2 summarises the episode of SC by physiotherapists.

TABLE 2

TABLE 2

Episode of care details for the vignette patient

Many advice and treatment options were reported for the management of the typical patient described in the vignette, and combinations of advice and treatments were commonly reported. Advice on aspects of pregnancy, low back pain and activities of daily living was reported by the respondents and, although combinations of treatments were described in packages of care, most physiotherapists reported using exercise approaches to manage women with pregnancy-related low back pain (Figures 2 and 3).

FIGURE 2. Survey findings: advice for the vignette patient.

FIGURE 2

Survey findings: advice for the vignette patient.

FIGURE 3. Survey findings: treatment for the vignette patient.

FIGURE 3

Survey findings: treatment for the vignette patient.

Acupuncture management

Regarding use of acupuncture, of the 469 individuals who responded to this item, 68% (n = 338) reported that they used it in the management of patients with musculoskeletal conditions, including low back pain not related to pregnancy, whereas 37% (n = 126 of 337 responses to this question) reported that they used it to treat women with pregnancy-related low back pain. However, when asked about the treatment they would provide to the specific patient described in the vignette (430 responses), 24% (n = 101) reported that acupuncture would be part of their treatment. Respondents had a mean of 11 [standard deviation (SD) 6.2] years’ experience of using acupuncture in clinical practice. The majority of respondents (298 responses) used Western/medical acupuncture (71%, n = 212), 16% (n = 48) used TCM/traditional acupuncture and 11% (n = 32) used trigger point/myofascial acupuncture. Of 336 respondents completing details about acupuncture training, 37.5% had completed up to 80 hours of acupuncture training (the national minimum requirement for physiotherapists), 53% had completed more than 80 hours but less than 200 hours and 9.5% had completed a degree/diploma in acupuncture or equivalent.

If acupuncture was a treatment option selected by respondents for the vignette patient, further details about acupuncture management were requested in the questionnaire. The mean number of acupuncture points used in a treatment session was 7 (SD 2.6), with the needles being left in situ for a mean of 20 (SD 6.0) minutes, and 84% of respondents would elicit a de-qi needle sensation. The selection of acupuncture points varied considerably for the vignette patient, and the 10 most commonly reported local and distal acupuncture points are summarised in Table 3. Only two acupuncture points (BL25 and BL23) were reported by more than one-third of respondents. Of those using acupuncture in the treatment of pregnant women, 22 respondents (4%) reported they had observed some minor adverse effects during treatment. These included the patient feeling lightheaded/dizzy (n = 8) or fainting (n = 5), mild bruising at needle site (n = 3), worsening of symptoms (n = 3), vomiting (n = 2) and significant pain at a needle site (n = 1). One respondent reported that a patient she had treated with acupuncture miscarried the day after acupuncture treatment, but reported that the treatment was not thought to contribute to this.

TABLE 3

TABLE 3

Most commonly reported acupuncture points for the vignette patient

Differences between respondents working in different practice settings (exclusively NHS or exclusively non-NHS) were few. However, those working exclusively in the NHS were more likely than those in non-NHS settings to report that they saw the patient only once or twice (52% compared with 17%). Conversely, physiotherapists reporting the most patient treatment visits (more than five) were more likely to be working in non-NHS settings (24%, compared with 7% in exclusively NHS settings). In addition, physiotherapists working in non-NHS settings more commonly than those working exclusively in NHS settings reported using treatment approaches that were classified as ‘hands-on’. Overall, the proportion of respondents who would offer the patient any hands-on treatment approaches was significantly higher among those who worked exclusively in non-NHS settings than among those working exclusively in NHS settings (Table 4). For example, of the 33% (101 out of 304) of respondents who would offer massage, 71 (70%) worked exclusively in non-NHS settings, compared with 30 (30%) who worked exclusively in the NHS.

TABLE 4

TABLE 4

Use of hands-on treatment approaches for pregnancy-related low back pain

Differences between professional networks

Exercise was the most common treatment reported by respondents from all three professional networks. Data about the typical episode of care (number of treatment sessions, length of sessions, length of episode of care) were also similar across all networks. The one area in which reported practice differed between professional networks was in the use of acupuncture for the typical patient described in the vignette, with respondents from the acupuncture professional network (the Acupuncture Association of Chartered Physiotherapists) being more likely to report using acupuncture (43.9%) than those from either a general musculoskeletal (the McKenzie Institute of Mechanical Diagnosis and Therapy Practitioners; 9.0%) or a women’s health professional network (ACPWH; 6.2%).

These survey findings, particularly those from NHS-based clinicians, were used to help develop the treatment content and intervention protocols for the pilot EASE Back trial in phase 2 of the EASE Back study (see The development of a standard care protocol).

Qualitative focus groups and individual interviews

Methods

The qualitative research was guided by our initial research objectives but retained the flexibility to explore previously unforeseen avenues of enquiry.54,55 Methods consisted of focus groups or individual interviews (in person or by telephone) with pregnant women, midwives and physiotherapists. Given that both health-care professionals56 and women57 can be difficult to engage in research, the offer of choice over interview format was pragmatic rather than methodological and intended to meet the needs of participants in terms of convenience. All participants were given full information about the study ahead of deciding to participate, with the option of focus groups or individual face-to-face or telephone interviews. The health-care practitioners were invited to complete a brief questionnaire to describe their qualifications and experience (see Appendix 2). Semistructured interview guides were developed from the research objectives and from the findings of the national survey. They focused on exploring the acceptability of acupuncture, the sort of information that might be required to reach a decision around participation in a trial, the most important outcomes and the most appropriate timing of outcome measures for the pilot trial. In addition, participants were also invited to talk about the care and support they considered available for this population (see Appendix 3 for copies of the topic guides). All interviews were audio-recorded with consent and the focus groups were facilitated by two members of the research team. Data collection was concurrent with all three sets of participants and ceased when data saturation was reached.

Interviews with pregnant women

For pregnant women, the original intention had been to hold a series of focus groups, offering individual interviews if these were more convenient. In the planned recruitment period for phase 1 of the study (June to September 2012) it was estimated that there might be as many as 600 pregnant women with low back pain under the care of the participating maternity hospital who could be invited to participate; however, owing to poor response to the invitation to participate in the interviews, we extended the recruitment phase by a further 2 months to November 2012. A convenience sampling strategy58 was adopted and any pregnant woman with back pain could either self-refer or agree for the health-care practitioner caring for her to pass on her contact details to the research team. A flyer and poster were designed outlining the study and providing contact details of the research team. In total, 3000 flyers and 100 posters were distributed through a variety of means: general maternity information packs when the woman first booked in with her community midwife; local antenatal clinics; community midwives giving the flyers directly to pregnant women under their care; and the women’s health physiotherapy service back class for pregnant women at the local hospital. In addition, an invitation to participate was also posted on internet sites [Mumsnet (www.mumsnet.com) and the Pelvic Pain Support Network (www.pelvicpain.org.uk)]. Contact was also made with the National Childbirth Trust (www.nct.org.uk) and the Pelvic Partnership (www.pelvicpartnership.org.uk), but administrative difficulties on the part of these organisations meant it was not possible for them to collaborate with the research team within the time frame of phase 1.

In total, 43 women gave consent to contact, which was attempted through telephone calls at differing times of the day, including in the evening, and a total of 18 women agreed to telephone interviews. On contact, if they were still willing to be interviewed, a convenient interview time was arranged. At that point, a letter confirming the interview arrangements, detailed information about the study and two copies of the consent form together with a stamped addressed envelope for the return of a signed copy of the consent form, were posted out. The information and consent form were discussed at the time of the interview and audio consent was also recorded then.

Interviews with midwives and physiotherapists

For the health professionals, a purposive sampling strategy was adopted to ensure a range of experience and perspectives.59 Two teams of community midwives were approached, together with the group of research midwives working in the local maternity hospital who would be involved in recruiting women into the EASE Back pilot RCT. Physiotherapists from the local community musculoskeletal outpatient services and from the local hospital’s women’s health physiotherapy service were also invited to participate. In addition, a sample of those physiotherapists (n = 30) who consented to further contact on returned questionnaires from the national survey were also invited to take part. Owing to geographical spread and participant convenience, these individuals were also interviewed by telephone. The individual interviews took place after the focus groups with physiotherapists and, because of data saturation, were limited to three individuals. In total, 15 midwives and 21 physiotherapists took part, giving a total of 53 individuals interviewed in phase 1 (Table 5).

TABLE 5

TABLE 5

Summary of participants in individual and focus group interviews (n = 53)

Analysis

An exploratory thematic analysis was adopted, within a constructivist grounded theory framework. Emergent findings were checked out in subsequent interviews across all three groups of participants in an iterative cycle.60,61 All interviews were digitally recorded, lasted between 20 and 60 minutes and were transcribed in full. To preserve participants’ anonymity, all were given unique identification numbers. To maximise the benefits of the interdisciplinary research team, the interview coders brought differing disciplinary perspectives to bear on the qualitative data (BB, social science; PB, acupuncture; and JW, physiotherapy). To ensure intercoder reliability, each independently coded a random selection of interviews as part of agreeing the initial coding frame, which was then applied across the whole data set, checking for consistencies and confounding cases and for further refinements of the coding frame. The findings were then compared with those from the national survey to identify areas of corroboration and contradiction.

Results

Engagement in the interviews

Despite the many flyers, posters and efforts on the part of clinical staff to discuss the study with potentially eligible women, and extending the recruitment period by 2 months, only 43 women agreed to contact by (or contacted) the research team. Of these, two self-referred, two were referred by physiotherapists, three were referred by obstetricians and 20 were referred to the research team by community midwives. The remaining 16 were identified through members of the research team attending the back education class within the women’s health physiotherapy service in the local hospital. We received no responses to the online invitations to participate that had been posted on Mumsnet or the Pelvic Pain Support Network. There were also challenges in making contact with the 43 women and in setting up focus groups. On average, it took five telephone calls spread over different times of day, including the evenings, to make initial contact. Two women declined to be interviewed during their first telephone contact (one no longer had low back pain and the husband of the other was ill) and 22 women were not contactable despite the five contact attempts. The difficulties in contacting these women were discussed at the focus groups with midwives and physiotherapists. They expressed little surprise, which they attributed to a patient population struggling to cope with everyday life and, moreover, discussions suggested that travelling to a focus group meeting would be an additional and unacceptable burden for pregnant women. The decision to offer individual telephone interviews instead of focus groups was made. Eighteen women agreed to interview, one was unavailable at the agreed time, and so a total of 17 women were interviewed over the 6-month period from June to November 2012, representing 39% of those who consented to further contact.

Characteristics of participants

Despite the initial difficulties in contacting women, the interview sample of 17 women was diverse and sufficient for data saturation. The average age was 26 years, with a range from 22 to 34 years; gestation ranged from 15 to 39 weeks, with a mean of 32 weeks; and for eight women it was their first pregnancy. In terms of ethnicity, eight described themselves as English, five were ‘other British’, three were ‘other white’ and one was ‘African’. All were either married or living with a partner and employment included health professional and clerical worker.

Analysis of the midwives’ profiles questionnaires indicated that the average length of practice was 18 years, with the majority (n = 9) qualified for over 12 years. The least experienced person had been qualified for 3 years, and there were also two maternity assistants included in the focus groups. None reported any specific postgraduate training around the area of back pain in pregnancy. Six midwives reported that they saw pregnant women with back pain either very frequently (at least one per week) or frequently (at least one per month). Just one midwife reported seeing such patients infrequently (at most one in the last 6 months).

As with the midwives, the physiotherapists were experienced practitioners. Their average length of practice was 12 years, nine had been qualified for 12 years or more (one for 36 years) and the least experienced person had been qualified for over 3 years. Fourteen individuals had a Bachelor of Science in Physiotherapy, of whom one also had a Master of Science in Musculoskeletal Healthcare, one a Master of Science in Acupuncture, one an Advanced Critical Care Practitioner (ACCP) foundation qualification in acupuncture and one Higher National Diploma in Sports Science. Another person had a Diploma in Physiotherapy, two individuals reported themselves simply as members of the Chartered Society of Physiotherapists (MCSP), and the final person was a physiotherapy technician with National Vocational Training Qualifications at Levels 1, 2 and 3. In terms of their contact with pregnant women, seven reported seeing such patients infrequently. All seven were community physiotherapists, and all apart from one reported that they had no specific postgraduate training in the topic of back pain in pregnancy. Unsurprisingly, the women’s health physiotherapists leading the hospital-based back class for pregnant women reported seeing such patients frequently. They identified that their education around treating pregnant women came from either in-house training or short (1-day) courses (the exact nature of these was not specified).

Key themes

We identified three main themes from the qualitative data in phase 1: the high burden of back pain in pregnancy and outcomes most important to women; the paucity of treatment options; and acupuncture as an acceptable intervention for women and midwives but generating concerns for many physiotherapists. Each of these main themes is presented briefly below with example quotations from the transcripts.

Theme 1: high burden of back pain in pregnancy and outcomes most important to women

During the interviews with these women a picture of the burden of low back pain in pregnancy and its often wide-ranging impact on daily life emerged strongly, corroborating the views of the midwives and physiotherapists, and highlighting the importance of flexibility in appointment times and treatment locations for the pilot RCT. The interview data highlighted the severely disabling effects of back pain during pregnancy, which can affect all aspects of life, ranging from sleep through to being unable to carry out basic activities of daily living. Many of the women reported considerable support from partners and family. However, there were also reports of serious misunderstandings in the workplace, arising from managers and/or colleagues seeing back pain as a normal part of pregnancy and expecting women to ‘just get on with it’, with resulting lack of support. For some, even attending routine antenatal appointments was difficult to negotiate with their workplace and, consequently, anything that might incur further time away from work was seen as challenging. This is particularly significant because many women reported needing to work as long as possible up to their due date, because of their maternity leave entitlement and for financial reasons. It was clear others in severe pain were unable to work or participate in social activities, with consequences for their mental well-being and relationships, as the following quote illustrates:

W8:

My mood at the moment is all over the place anyway [laughs], but it [the pain] affects you, because it does limit me, especially first thing in the morning when I’ve been in one position for a long period of time, it kind of freezes up. So in the morning when I get up, I kind of crawl out of bed rather than spring out of bed.

Individual interview: 56

The women interviewed did not expect to experience immediate pain relief with acupuncture but believed that it would take several treatments to make a difference. The severity of the pain and its impact on activities of daily life meant that they felt that it was unlikely the pain could be completely resolved but rather alleviation was seen as an acceptable outcome:

W10:

I know nothing can sort of get rid of my pain completely but perhaps just alleviate, you know, something to alleviate it for a little bit and enable me to sort of get around and move around a little bit more [yeah] you know? I think that would be a pretty good outcome really.

Individual interview: 156

Theme 2: the paucity of treatment options

The responses to the survey indicated that SC varied widely for this patient group. This variation in care and lack of effective treatment options were also reflected in the narratives from women and professionals. It was clear that the emphasis is on self-management strategies, with only the most severely affected women being referred to physiotherapists for individualised advice about posture, movement and gentle exercise. Both midwives and physiotherapists tended to view these women as ‘heart-sink’ patients for whom they could offer very little in the way of effective interventions, as this illustrates:

P4:

I think it’s one of the few types of patients that we won’t see more than once because you know that, physio-wise, there’s very little to offer. So it’s a case of give them what they need and leave them on hold for further appointments.

Community physiotherapists: group A, 48

Midwives and physiotherapists reported explaining the causes of back pain during pregnancy as a way of reassuring the women and, although they described offering advice, they felt that this amounted to ‘fobbing off’ their patients, expressing a lack of faith in the effectiveness of their suggestions. Moreover, the advice provided was clearly highly variable, indicating uncertainty among midwives and physiotherapists regarding the most appropriate forms of advice, and there clearly were no consistently used sources of advice in terms of either written leaflets or website resources. Examples of patient information leaflets (PILs) and websites recommended to women were collected from respondents to the national survey, and the 37 different leaflets returned underline the variation in current advice provided to these women. This reflects the uncertainty voiced by the professionals about what constitutes ‘the right advice’ for this group of patients. Most women were advised to try self-management techniques around posture, gentle exercise and pain relief medication. Women’s health physiotherapists reported favouring a ‘hands-off’ approach, with advice on posture, preparation for labour and delivery and feeding positions after delivery. They identified an important part of their role as providing reassurance. The uncertainty about what constituted ‘the right advice’ for this group of patients was reflected in the accounts of the women, who conveyed a sense of being left to ‘get on with it’, as this severely affected individual reported:

W6:

No, I refused to take that [co-codamol]. They did prescribe it in the end and I did take it home with me but I haven’t took any because I just don’t agree with that in pregnancy. And after that I was discharged because really there’s nothing you can do. They referred me to the physio back class that I went to, and every time I’ve seen my midwife, she gave me a little tip of how to get in and out of cars, and things like that. But I don’t really think it can be helped. I just think it’s one of them things you’ve got to deal with.

Individual interview: 75

Theme 3: acupuncture as an acceptable intervention for women and midwives, but generating concerns for many physiotherapists

Although some women did express the need for information and reassurance over safety of acupuncture and whether or not the positioning for acupuncture would require them to lie in positions that could exacerbate their pain, in the main women expressed little concern expressed about its use in pregnancy.

W17:

I think if people were telling me that it could help my back pain then I would pretty much do anything.

Individual interview: 149

W2:

I don’t know where they put the needles in pregnancy. If they were in my tummy I think I’d be a bit like, ‘mmm, not quite sure about that’.

Individual interview: 98

Midwives were generally in favour of the idea that acupuncture could be offered to women with pregnancy-related back pain and that it could offer a useful additional treatment option. They felt that many women would be interested in knowing more about acupuncture for their back pain, particularly those women who are severely affected, and who, they felt, would be willing to try it within the context of a trial. The midwives felt that pregnant women with back pain under their care would have few concerns about acupuncture and these would be most likely linked to the location of and sensations from the needles, as this focus group excerpt indicates:

M1:

[They’ll] want to know where you’re going to put the needles.

M2:

That’s the first thing I’d ask.

M3:

Yeah, and they’d want to know if it hurts.

Community midwives: group B, 373

Physiotherapists were also generally in favour of testing the additional benefit of acupuncture for this patient group in a trial because of the difficulties in treating the pain through other treatment methods.

P4:

I mean, it’s [acupuncture] very interesting because drugs do not seem to work for these women. You know, talking about sort of real heavy painkillers . . . We had a lady admitted last week and was immediately put on morphine, it didn’t touch her pain at all. And all that does then is make the baby sleepy, and the mum sleepy. So for some women it is very difficult pain to manage.

Women’s health physiotherapist group

However, the physiotherapists raised concerns about safety of acupuncture in pregnancy, given their previous acupuncture training during which they recalled they had been advised that acupuncture was contraindicated in pregnancy.

P3:

And again like the previous two people, I thought acupuncture was contraindicated, that was part of my training. And I wouldn’t have done it to a pregnant lower back pain patient.

Community physiotherapists: group B, 57

Such concerns included the general safety of acupuncture in pregnancy and the specific acupuncture points and techniques to be used, and these concerns were rooted in their lack of confidence and/or experience in caring for pregnant women, as this excerpt indicates:

P2:

With them being pregnant, you’re just so aware that they’re pregnant and you feel limited to what you can do because you don’t want to . . .

P3:

I think we’re just scared to hurt them, aren’t we?

Community physiotherapists: group A, 81

This fear was related to concerns over a perceived lack of adequate training, specifically in the application of acupuncture in pregnancy:

P6:

I don’t think I’ve got the training to do it. There might be other stuff out there, but I don’t feel that I’m well enough equipped to deliver other things.

Interviewer:

Is that the same for everybody?

P1:

Yeah. I think because we don’t see them often enough, we don’t – there isn’t the training out there. We don’t know exactly . . .

Community physiotherapists: group A, 95

Such fears around possible harm to the mother and/or baby generated a culture of caution, underpinned by a fear of litigation. Although most physiotherapists shared these fears, the three who participated in individual interviews and who practised acupuncture with pregnant women held starkly contrasting views. They worked in NHS musculoskeletal outpatient departments in which acupuncture was available. One had been qualified for 11 years, one for 18 years and one for 28 years. They were confident about the safety and efficacy of acupuncture for this population and indeed considered it safer, in fact, than medication, as illustrated by this quotation:

SP1:

I would use acupuncture as a first choice of treatment with pregnant ladies over medication because of the safety risks with medication. In fact, I find my pregnant patients respond better [to acupuncture] than perhaps my standard lower back pains.

Physiotherapists’ survey

These interview findings were pivotal in developing the content of the training and support programme offered to physiotherapists participating in the EASE Back pilot trial in phase 2.

In addition, both the midwife and physiotherapist interviews highlighted a number of issues around recruitment, including the importance of detailed patient information and reassurance (about the acupuncture needling, any known side effects on the baby, information about positioning during treatment), flexibility around time and location of treatments and generally minimising the research burden on participants. The fact that the issues emerging through the interviews and focus groups were consistent with some of the survey responses acted as a further form of validation. The qualitative results specifically about physiotherapists’ concerns in using acupuncture during pregnancy also help explain the practice patterns seen in the survey responses. The findings from the qualitative interviews were incorporated into the participant information leaflet, the recruitment methods, the selection of treatment sites, the treatment protocols and the outcomes for the EASE Back pilot trial in phase 2.

Implications for recruitment to the pilot randomised controlled trial

The challenges in recruiting pregnant women to participate in the phase 1 interviews made it clear that we needed to develop and test a range of approaches to identify and recruit eligible women for the pilot trial in phase 2. Originally the plan had been to raise awareness about the pilot trial by inserting a flyer within the booking information pack given when seen by their community midwives and for women with back pain in pregnancy to be given an information pack about the trial by their usual midwife. We tested these approaches in phase 1, and overall these approaches alone were not particularly successful in identifying suitable women who were willing to be involved in the interviews. Recruitment of this population to research in phase 1 was clearly challenging, and therefore we used the results of the interviews with pregnant women, midwives and physiotherapists as well as suggestions for additional recruitment methods from research midwives who had worked on other research studies with pregnant women in order to agree six methods with which to identify and recruit women to the pilot RCT in phase 2. While using six methods was complex for a pilot trial and we had not originally included these costs of some of these methods in the grant application, we were keen to test out the methods in order to identify a smaller set of methods that might work best for a future large trial. The details of the six methods are provided in the next chapter (see Chapter 3, Recruitment methods and procedures), but they included a brief questionnaire that screened for the presence of back pain and willingness to be contacted further among women attending their antenatal 20-week ultrasound scan appointment and a local awareness-raising campaign that included use of a study website, newspaper, radio and other local media in order to take the message about the study directly to local pregnant women who could then opt to self-refer to the research team for eligibility screening.

In addition, we had planned that research midwives would screen all women for eligibility in face-to-face information and consent meetings. Through discussions with the research midwives it was agreed that a much more efficient use of their time would be to conduct brief telephone screening first and invite only those who appeared potentially eligible to face-to-face meetings for full eligibility screening, informed consent and baseline data collection.

Specification of information and interventions for the pilot randomised controlled trial

The development of the participant information leaflet

In order for potential participants to be fully informed about what taking part in the pilot trial in phase 2 would involve, a detailed PIL was developed. The format and content of the PIL was both based on a best practice example provided within the good clinical practice and regulatory requirements for clinical trials and taken from the findings of the qualitative research in phase 1. Information was provided not only on the rationale of the study, why women were being invited to take part, what taking part would involve, issues around anonymity and confidentiality, payment and the funders of the study, but also on the acupuncture treatment. This specific information included the required positioning for treatment, the difference between acupuncture needles and other types of needles (e.g. those used to take blood), whether or not children were able to attend appointments, the ability to drive after treatment and the known risk of specific adverse events from acupuncture during pregnancy. The PIL was reviewed by patient representatives on the Trial Steering Committee (TSC) and amended following feedback. A copy of the PIL is in Appendix 4.

The development of a standard care protocol

Given the variation in SC for pregnancy-related back pain, we sought to use the results of the national survey and the qualitative interviews, along with available research evidence, to specify a SC intervention protocol for the pilot RCT. The protocol included a high-quality and comprehensive self-management booklet and, for those who needed it, an onward pathway to individualised assessment and treatment with an EASE Back study physiotherapist.

Self-management booklet

The national survey resulted in the research team receiving examples of 37 different advice and self-management leaflets currently used by physiotherapists across the UK. These were used to help develop the specific self-management booklet used in the pilot RCT. Other than the professionally produced leaflet Pregnancy-Related Pelvic Girdle Pain, published by the ACPWH, all others were examples of brief and inexpensive leaflets produced by individual NHS trusts or individual clinicians. It was clear that none was clearly fit for purpose for use in the EASE Back pilot RCT and, therefore, we developed the EASE Back: Managing Your Back and Pelvic Girdle Pain in Pregnancy booklet specifically for use in phase 2. The available leaflets were reviewed for common themes and good examples of both content and layout, taking into account the issues raised by pregnant women, midwives and physiotherapists during the phase 1 pre-pilot work. We sought to develop a booklet that would be seen as more comprehensive than those available to date, that was produced in colour, of high quality, with clear photographs of real pregnant women (rather than diagrams only, as was the case in most of the available examples), divided into sections and with clear page numbers and handy hints boxes throughout. We also wanted the booklet to be of a size that women could fit into their handbag so that they could, if they wished, carry it around with them and thus refer to it during the day (most of the available examples were photocopied A4 sheets of paper). Working with the women’s health specialist physiotherapist at the participating hospital [University Hospital of North Staffordshire (UHNS)], who was also a member of the ACPWH, we developed sections for the booklet about the good prognosis of back pain in pregnancy, advice about appropriate self-management of back pain in pregnancy, including pacing between activities and rest, simple exercises to try at home, advice on adaptation in lifting techniques, tips about relieving postures for sitting, standing and sleeping, advice about work and continuing with everyday activities, the use of pelvic supports/belts and supportive pillows, and the use of simple and safe analgesics. We also included some self-management hints and tips, advice for labour and after the birth, a summary and useful websites.

The booklet was reviewed by patient representatives (women with experience of pregnancy-related back pain) on the TSC, physiotherapists and an antenatal and postnatal exercise specialist before we finalised the content, photographs and layout. A copy of the booklet is included in Appendix 5. In the pilot trial, the booklet was posted to all trial participants, who were advised to follow the advice and exercises in the booklet and that, if they felt they needed to see a physiotherapist, they should discuss this with their community midwife (as in usual care) and then book an appointment with an EASE Back study physiotherapist.

One-to-one standard care physiotherapy

We protocolised the number and content of physiotherapy sessions for the pilot RCT using the data from the national survey and qualitative interviews. We knew that women who were severely affected would need help with pain and function, and that onward referral to physiotherapists for assessment, advice and treatment needed to be available within the SC protocol. Therefore, we provided information in the SC information pack on how to access EASE Back study physiotherapy care should both the woman and her midwife feel this was needed and we developed an EASE Back study SC protocol for those women, based on the results of our surveys and interviews from phase 1. This involved an individualised assessment of the problem, individualised advice particularly about posture and a home exercise programme (focusing mainly on stabilising trunk exercise and pelvic floor muscle exercise but which could include stretching, pelvic tilt exercises and gluteal muscle strengthening), with treatment options that included supportive Tubigrip™ (Mölnlycke Health Care Limited, Dunstable, UK), pelvic supports/belts, manual therapy including massage, supervised exercise therapy and use of walking aids for those that might need them. Hydrotherapy, group treatments and acupuncture were not permitted within the protocol for SC alone. If women enquired about or engaged in antenatal aqua classes this was fine, as long as the treatment from the physiotherapist did not involve exercise in water. The episode of care consisted of between two and four treatment sessions over 6 weeks, with the episode of care left open until the end of the pregnancy, in line with our survey findings.

The development of the acupuncture treatment protocol

The results from the national survey and the interviews with physiotherapists who used acupuncture in the management of pregnancy-related low back pain and PGP were used, alongside evidence from previous trials, to specify the content and delivery of the acupuncture treatments in the pilot RCT. We attended to the need for an individualised approach to acupuncture (in terms of selection of initial points to be needled and the flexibility to change the selection of points over the series of treatment sessions) while also needing to be able to describe the range of points that therapists could select from. Thus, following individual patient assessment including examination of tender points, physiotherapists could choose the most appropriate true acupuncture points for the individual patient from a long list of potential points. The agreed list of points was based on our survey findings and previous trials in similar patient populations. We ensured that formal service-level agreements with participating physiotherapy services stipulated between six and eight treatment sessions should be delivered within 6 weeks (based on the survey results and balancing the need to offer sufficient acupuncture sessions to be effective while also providing a treatment course that might be suitable for the NHS in future). Full details of both the true and non-penetrating acupuncture protocols are provided in Chapter 3, Interventions.

Development of training programmes for participating clinicians

Training programme for research midwives and nurses

The research midwives and nurses involved in the EASE Back pilot trial (n = 8) attended a half-day training programme prior to recruitment commencing, which included lectures, practical sessions, role play, group discussion, problem-solving and case studies. During the training programme, the research midwives and nurses were informed about (1) the rationale and design of the EASE Back study, including how the findings from phase 1 had informed the design of the pilot trial and (2) the planned procedures involved in identification of potentially eligible women, screening, gaining written informed consent, audio-recording a sample of the face-to-face screening and consent meeting, baseline data collection and the randomisation and completion of maternity record reviews after trial participants had given birth. Audit procedures were also finalised; these included clinic activities such as informed consent, guiding women in the performance of the two objective tests for PGP, the telephone calls to the randomisation service at the Clinical Trials Unit (CTU) as well as the collection of minimum data over the telephone at follow-up. A summary of the half-day training programme is provided in Appendix 6.

In order to consolidate learning, the initial half-day training programme was followed by a 2-hour refresher session that took place immediately prior to commencing recruitment in the pilot RCT. This included role play of a number of different scenarios from the point of initially identifying potentially eligible women, completing screening and eligibility checking over the telephone and completing the face-to-face screening and consent meeting. Example scenarios included women who were ineligible for various reasons, women who were eligible but who declined participation and women who were eligible and provided informed consent. Throughout all scenarios, study documentation was completed to enable the research midwives and nurses to become familiar with it before starting recruitment, and all research midwives and nurses were observed by a member of the study team to ensure that they were competent in completing all study eligibility screening and recruitment procedures as planned.

Training programme for physiotherapists

All the physiotherapists providing care in the pilot trial were trained in the use of acupuncture for pain conditions, in training programmes that met national standards. The EASE Back pilot trial training programme for participating physiotherapists took place over 3 full days and a copy of the programme content is available in Appendix 7. Day 1 summarised relevant literature, including the changes during pregnancy to women’s bodies, the potential explanations for back pain during pregnancy, assessment of pregnant women with back pain (with or without PGP), and SC for pregnancy-related back pain, including key findings from phase 1. Day 2 focused on acupuncture for pregnancy-related back pain, available data on safety of acupuncture for this patient population and the details of the EASE Back study protocols for both the true and non-penetrating acupuncture treatments. Day 3 combined SC and acupuncture protocols together using patient case studies and included information about the practicalities of the trial, including use of EASE Back trial case report forms (CRFs); how to deliver the trial protocols, stressing the importance of patient blinding; and identification of any adverse events or SAEs. Training included lectures, group discussion and use of patient case examples, as well as practice of assessment and treatment skills. We trained 14 physiotherapists to deliver the treatments in the EASE Back pilot trial, supported by a training team including an expert acupuncturist, a women’s health specialist physiotherapist and a consultant obstetrician. Ongoing support to deliver the treatments in the EASE Back trial was provided by an expert acupuncturist and a women’s health specialist physiotherapist; this support took the form mostly of telephone and e-mail communications as well as some face-to-face visits during which the acupuncturist observed participating physiotherapists’ treatment sessions with patients and provided feedback and support. Physiotherapists completed a brief questionnaire before and immediately after the training programme and at the end of the pilot RCT, in order to describe physiotherapists’ characteristics and explore changes in their intended management of a patient with pregnancy-related low back pain and in their confidence to assess and treat this population. The results from these questionnaires are summarised in Chapter 3, Physiotherapists’ questionnaire results and feedback.

Conclusions

In conclusion, the pre-pilot work in phase 1 provided high-quality data on current UK SC and acupuncture treatment for back pain in pregnancy. The survey and interviews results, particularly those from NHS-based clinicians, were used to help develop the intervention protocols for all the treatment arms in the pilot randomised trial in phase 2 of the EASE Back study. The interview findings from pregnant women, midwives and physiotherapists informed the content of the patient information materials, the recruitment methods and the clinician training programme for the pilot trial in phase 2, reported in Chapter 3.

Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Foster et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK360958
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