Content and outcome of usual primary care for back pain: a systematic review

Inclusion criteria for studies to review

Search strategy for identification of studies

Relevant studies meeting the inclusion criteria were identified by a computer search of the electronic databases MEDLINE (1966–2007), EMBASE (1966–2007), CINAHL (1982–2007), AMED, DARE, and ISI Web of Science. The search strategy looked for terms within the subject heading, title, and abstract, and included the following terms: random, clinical trials, low back pain, back pain, backache, physicians-family, family practice, general practice, family medicine, primary care, and primary medical care (Appendix 1). The search was augmented by examination of the Cochrane Central Register of Controlled Trials and references given in the identified randomised controlled trials and appropriate reviews.

Methods of review

Study selection

The initial search yielded 164 potentially relevant studies. After examining the full text of 54 papers, 33 were included in the review.3^,12^–43 This process is detailed in Figure 1.

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Figure 1

Systematic review flowchart.

Study characteristics

Study characteristics are presented in detail in Appendix 2. Type of care given or intended to be given in the usual care control group is described, in addition to the outcome of the experimental intervention compared with usual care.

Of the 33 studies identified, eight investigated patients with acute back pain,13^–15^,32^,34^–36^,39 11 with patients who had subacute pain,16^,18^–21^,23^,27^,33^,38^,41^,42 six examined patients with chronic pain,17^,24^–26^,31^,37 and eight studies investigated patients with mixed-duration pain.3^,12^,22^,28^–30^,40^,43

Baseline RMDQ score, where appropriate, is given to describe the severity of back pain in participants entering the trials. The studies were conducted in Australia, Canada, Finland, Mallorca, the Netherlands, Norway, Sweden, UK, and US. Thirty out of 33 studies assessed were deemed to be of good quality (that is, they achieved a quality score of ≥3 out of 5).

Methodological quality

In the 33 studies, one study scored 1,34 two scored 2,27^,30 13 scored 3,12^,17^,19^–22^,26^,29^,32^,37^,40^–42 16 scored 4,3^,14^–16^,18^,23^–25^,28^,31^,33^,35^,36^,38^,39^,43 and one scored 5 out of a maximum score of 5.13 In 16 out of 33 studies it was not possible to tell if the outcome assessor was blinded,3^,12^,17^–22^,26^,27^,29^,30^,34^,37^,41^,42 and in only three of 33 studies were the patients blinded to the nature of the treatment group.3^,13^,18 In two studies it was not stated if the treatment allocation was concealed,30^,40 and in three it was not possible to tell if the analysis was by intention to treat.27^,32^,34 All papers reported the drop-out rates.

Content of usual care approaches

Medication

Only 12 out of 33 studies gave information about medication taken by patients for their back pain.3^,15^,21^,24^–26^,31^,33^,38^,39^,41^,43

Many patients were taking medication at baseline, with figures reported of 69%,39 80%,24 90%,43 and 69% (prescribed) and 73% (over the counter).21

Two papers gave information about opioid prescription: 34% of patients in a US study,15 and 18.7% in the UK3 were prescribed them. Unfortunately, there was no information about the strength of the opiates or whether combination drugs were prescribed.

Work absence

Information about absence from work was quite heterogeneous due to the way in which authors recorded this information and differences in the type of usual care; some studies only recruited patients who were absent from work because of back pain.33^,35 It is important to remember this when comparing data about sick notes from different countries. The different procedures for obtaining a sick notes in different countries may give a false interpretation of the data. As mentioned in the paper Dutch GPs do not give sick notes, British GPs do.

Activity levels and exercise advice

Three studies gave details on the activity levels of patients before they presented to their GP19^,32^,33 and three reported the advice given to patients about exercise during the trial.15^,31^,33

Clinical course of patients randomised to usual care

Functional disability (RMDQ score)

The data shown in Figures 2a and 2b suggest that the speed at which RMDQ scores improve is inversely related to the duration of back pain: that is, the longer the duration of pain, the slower the rate of improvement. In acute and subacute pain there was a definite trend for improvement. The single study that did not follow this trend16 involved usual care provided by university-affiliated clinics and the emergency department of a hospital in an inner-city setting in the US; as such, these patients may not be representative of patients normally managed in primary care.

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Figure 2a

Change in Roland–Morris Disability Questionnaire (RMDQ) scores over time according to duration of acute/subacute back pain.

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Figure 2b

Change in Roland–Morris Disability Questionnaire (RMDQ) scores over time according to duration of chronic back pain.

Satisfaction

For acute pain, mean satisfaction scores at study endpoint were 7.2 (treatment),35 7.0 (explanation),35 and 4.1 (overall), according to the 0–10-point satisfaction scale used to rate the studies.15 In subacute pain, endpoint satisfaction scores were 4.7,33 and 4.1.19 In one study on chronic back pain the mean endpoint satisfaction score was 4.4.24 A study on mixed-duration back pain expressed this differently, with the number of patients who were very satisfied or satisfied at 85% following their initial consultation, and at 70% after 6 weeks (Figure 2c).22

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Figure 2c

Change in Roland–Morris Disability Questionnaire (RMDQ) scores over time according to duration of mixed back pain.

Methodological quality

That many studies did not have blinding of patients or outcome assessors is not unusual. Often blinding is not possible, or even sensible, due to the pragmatic nature of the trial design, the interventions used, or ethical constraints.

Studies were presented in different ways, which made quality assessment and data extraction difficult to carry out. Future randomised controlled trials on back pain should be presented in line with Consolidated Standards of Reporting Trials (CONSORT) recommendations.44

Overall, most papers reviewed were of an acceptable quality according to the study's quality scale. A small number of trials failed to describe concealment of allocation to treatment,30^,40 or intention-to-treat analysis.27^,32^,34

Direct comparison between studies was difficult due to the differing ways in which data were recorded. For example, pain experienced by patients was assessed using Visual Analogue Scale, modified Von Korff Pain Scale, Aberdeen Back Pain Scale, and the Extended Aberdeen Spine Pain Scale. Nevertheless, the patterns of changes in pain were similar to those for disability, with patients with acute and subacute back pain showing larger improvements than participants with chronic back pain.

Description of usual care

Overall, usual care was poorly described in these studies. Historically, there has been a tendency to allow care in the control group to be according to the normal practice of the care provider, with little or no recording of what actually took place. This contrasts with the intervention treatment, against which usual care is compared, which is often described in great detail.

It is clear that healthcare providers vary widely in their preferred practices, due to many factors including their experience and the expectations of the population in which the studies are set. As such, control groups in separate studies reviewed here may receive a range of different treatments. This makes comparison between studies difficult.

Although the practice of comparing a new treatment with the prevailing current practice is well accepted, interpretation of such studies is problematic when the usual care groups vary so widely and are not adequately described. This is particularly pertinent given that a healthcare provider may act differently purely by knowing their practice is under scrutiny.

Attempts to standardise usual care have shown little effect in changing clinician behaviour.3 It is important to accept that usual care is heterogeneous, and this needs to be taken into account when interpreting the results of studies. The present authors suggest that a minimum dataset about usual care is recorded to improve understanding of the treatments received in the usual care group (Table 1 and Appendix 2). This includes information about radiology usage, other investigations ordered, medications used (prescribed or over-the-counter), sick notes issued, use of written materials, recording of activity levels, details of exercise advice given, consultation rates, physiotherapy undertaken, and hospital referrals.3

Content of usual care

It is difficult to draw any firm conclusions about how frequently primary care consultation is allowed or what actually happens in the usual care approaches. Marked differences existed in the control groups due to the country involved, variation in the study designs, and methods of recording consultation activity; only half of studies reported data and the results showed no pattern.

Similarly, the overall recording of medication use was quite poor. This is disappointing in that medication use has significant financial costs for the patient and the health economy, and is associated with a not-insignificant number of side-effects.

This review found that many patients take over-the-counter medication for their back pain, and GPs often provided additional medication. Data were limited, but there was a suggestion that levels of opioid prescription were quite high,3^,15 given the message in back-pain management guidelines that suggest using weak opioids as ‘add-on’ treatments when paracetamol or non-steroidal anti-inflammatory drugs provide insufficient pain relief.8^,45 Compound analgesics are not recommended as they do not allow separate titration of the constituent medications, and there are concerns about dependence with strong opioids.8^,45

Unfortunately, in the studies in this review, information was not recorded about the strength of opiates or whether combination products were used. It may be that the concerns about strong and combination opioids are overemphasised, particularly when the majority of patients will recover from their back pain in a few weeks. A GP faced with a patient who is in pain, despite taking simple painkillers, may well decide that it is appropriate to prescribe these drugs in the short term, but with close monitoring for side-effects and over-usage. It is important to record more detailed information about the types of drugs used to treat back pain, and their effectiveness and safety.

It is generally accepted that plain-film X-rays are not helpful in the management of most patients with back pain and represent an avoidable source of radiation.6^,46^–48 This review found that the use of X-rays varied widely between countries, from 4% of cases in the UK,29 to 53.6% in Canada.33 Reasons for requesting investigations are complex and involve many factors including patient and doctor beliefs and knowledge, country-specific healthcare systems, and patient satisfaction.

The tension between guideline advice and actual clinical behaviour is illustrated by a survey of GPs that found that they would almost always or sometimes refer for X-ray in 70% of patients with non-recurrent backache of less than a month's duration: 88% per cent of requests were to reassure the patient, and 78% to reassure the doctor.49 This finding is not confined to low back pain consultations, and it has been shown that perceived patient pressure, rather than clinical need, is the reason behind a significant minority of investigations.50 Clearly, it is desirable to reduce patient exposure to radiation, but to achieve this goal a guideline must be of practical use to doctors in primary care. The guideline must include adequate explanation of the rationale behind each recommendation, address the needs for reassurance on the part of the patient and doctor, and be adaptable to local resources (for example, it is no use advocating magnetic resonance imaging instead of plain-film X-rays if it is not readily available).

The clear messages from trials and guidelines are that patients with low back pain should continue with normal activities, even if uncomfortable, and stay at or return to work.8 The papers included in this review did not, in general, report on this important aspect of patient care. One possible reason for this might be that is not the normal practice of GPs to record this information. Also GPs may not feel able to give specific advice about exercise, due either to lack of training or fear of litigation should the patient develop a problem related to exercising. GPs are well placed to give exercise advice to patients, and there is a need to address these issues to encourage and support people who would benefit from increasing their activity.51

Course of symptoms

The relatively small number of studies involved makes it difficult to undertake a meaningful data synthesis and arrive at firm conclusions. However, Figures 2a and 2b suggest that the speed at which the RMDQ score changed over time depended on the duration of the back disorder. For acute pain there was a trend for RMDQ scores to fall rapidly over the first few weeks (Figure 2a), and this improvement was maintained throughout the study period. For chronic pain sufferers the outlook was much less promising, and RMDQ scores did not tend to improve with time.

Usual care groups in the studies in this review were given a range of treatments but, despite this, it appears that the effectiveness of usual care (if measured as improvement of RMDQ score) may be related more to the duration of the episode than to the type of care given.

Usual care is variable in content and effectiveness. That it is also poorly described compounds this problem and makes comparison between studies even more difficult. As such, it is important that usual care is not regarded as a uniform control against which interventions are compared without attempting to understand what it consists of. This heterogeneity may undermine the fundamental basis for calculating sample sizes in future trials. Agreement is needed as to what information should be recorded in future trials, and conformity to CONSORT needs to be improved.