Low back pain management in routine clinical practice: what is important for the individual patient?

Low back pain (LBP) is an extremely common health problem affecting all age groups [1]; it is the leading cause of disability world-wide [2]. With a lifetime prevalence of 85.5% [3], the majority of adults in Germany might be affected by back pain at some point of their lives. In most cases, this may be a transient discomfort often related to lifestyle or requirements at work such as frequently lifting or carrying heavy loads or spending a large part of the day in front of a computer. Whatever the cause, the back will sooner or later complain about the unbalanced strain leading to acute back pain, often affecting the lower back. There are, however, multiple other reasons why a patient may suffer from back pain, some complex, not yet fully understood or even discovered. For between 4 and 25% of sufferers of low back pain [4], there will be no spontaneous or fast recovery; pain persists and is deemed chronic if it continues for more than 3 months. In Germany, results from the 2017 NAKO health study [5] and the BURDEN 2020 study [6] showed that 22.5% and 15.5% of participants, respectively, reported chronic back pain. A recent article described the patient journey from onset of LBP symptoms to severe chronic LBP (cLBP) [7]. Patients initially present with a ‘simple problem’ and may benefit from exercise or physiotherapy, mild analgesics, or changes in lifestyle [7]. Besides physical/physiological causes, personal disease experiences and psychosocial factors should be considered [8]. The ‘simple problem’ might, however, be the start of a long and arduous pain journey with increasing functional impairments, the development of comorbidities and decreasing quality of life.

cLBP is a complex disorder and individual profiles of patients are highly variable [9]. It is influenced by biological, psychological and social factors and causes are varied; symptom burden as well as personal circumstances also show large variations [10]. Patient care thus needs to be tailored to the individual. Patients with cLBP may see any number of healthcare professionals ranging from their primary care physician via physiotherapists and orthopedists to pain physicians and sometimes surgeons. Patients' initial and most frequently addressed treatment goal is pain relief; from the healthcare professional point of view, regaining function or participating in physiotherapy or exercise (in particular in the case of severe pain) is often only possible with sufficient analgesia. When all alleyways of solving the disorder with simple means such as physiotherapy or massage have not led to sufficient pain reduction and other interventions such as various types of injection (e.g., steroids, nerve blocks), or sometimes surgical measures have been exhausted, some patients may still be in significant pain requiring strong analgesics.

A good and trusting physician–patient relationship is an important if not crucial basis for successful pain management. It requires clear communication between patient and respective healthcare professional. Many patients with LBP are dissatisfied with the approach to care and perceive a lack of good communication, shared decision-making, provision of information and a holistic, individualized treatment [11]. Whereas physicians often consider technical skills such as expertise, knowledge and competence as important factors for a good relationship [12] (skills which should be taken for granted in a trained physician), interpersonal skills or behaviors such as empathy and caring are expected by the patients beyond this technical knowhow [12]. These latter skills can be summarized as emotional care, which comprises mutual trust, empathy, respect, genuineness, acceptance and warmth, and cognitive care encompassing sharing medical information, patient education and expectation management [13]. Patients feel reassured when taken seriously [14], which increases their confidence [15]. They want physicians to be ‘truthful about not having all the answers’ and to listen and show empathy [16]. Lack of these interpersonal skills may lead to loss of trust and satisfaction [12] and lengthy and/or unsuccessful treatment. A good physician–patient relationship has been associated with fewer diagnostic tests and referrals, improved patient satisfaction and emotional health [17], adherence to the prescribed treatment and recommendations [18–20], and improved healthcare outcomes such as e.g., pain relief [13]. If the expertise and knowledge considered important by the physician are shared with the patient (cognitive care), this may lead to shared decision making in pain treatment concerning definition of goals, and to any treatments/measures initiated to achieve these goals (including choice of pain medication, decision to try opioids in severe cases and decision to switch, reduce or discontinue opioids after successful treatment).

The present paper explores which treatment goals are important to patients with cLBP beyond pain relief. A hypothetical patient case presents the frequently observed cLBP pattern from the author's pain specialist practice and shows the importance of realistic treatment goals. These observations are supported by clinical data from analgesic studies the author was involved in. To determine which treatment aspects/goals are important for the individual patient, an online patient research survey was additionally carried out.

A typical LBP case

The following describes a frequently observed pattern in cLBP in the author's pain specialist practice and presents it in the form of a hypothetical patient case.

When 68-year-old patient M first presented to the pain practice with cLBP, he had already been suffering from pain for almost 8 years and had a long record of different tried therapies. These included early phases of self-treatment and the involvement of different healthcare specialists, different medications, physiotherapy and others. Some years ago, he had undergone moderately successful surgery for spinal stenosis, however, the pain had become increasingly severe. Being asked about his personal situation, the patient mentions that he loves gardening but is unable to work in the garden at the moment, because bending down is difficult, and he can't even mow the lawn any longer. He, therefore, spends his days inside (on his own, as he has been widowed some time ago). He can still do the shopping and cooks his own meals but has problems with his personal hygiene and needs somebody to clean the house for him. Patient and physician jointly decide to try a stronger pharmacological treatment approach with a strong opioid which is to be titrated initially to a low maintenance dose. Patient and physician also discuss treatment goals and the doctor explains that 30–50% pain reduction in the next 3 months or ‘at least’ an improvement of movement or functioning might be realistic goals.

At the next visit, the patient reports a satisfactory reduction of his pain with only minor and acceptable side effects. As the treatment seems to be adequate, the physician advises continuation of the low-dose opioid treatment.

When the patient presents again 3 months later, he is no longer satisfied with the prescribed pain medication. After the initial pain relief, the pain now seems to be as severe as before. He describes many situations in which the pain seems to be unbearable. This consultation is often a decision point where a change in medication is considered, however, discussing this particular patient's current symptoms and current life situation, the physician learns that the patient has recently resumed work in the garden including mowing the lawn. The patient is astonished when it is pointed out to him that he was able to do activities again he was unable to do at the start of treatment. And, after being asked and on reflection, the patient states that he is generally more content and fulfilled since working again in the garden and that his quality of life has improved. The physician reminds him of the discussion about treatment goals they had at the first visit, and they agree that the goal of improvement of movement/functioning has been achieved. For this specific patient, the goal of being able to do certain activities was at least as important as pain relief alone. Here, pain relief was the means of regaining other abilities, in this case functional improvement. The physician and patient jointly decide not to adjust the pain medication at this stage, but the patient will take it a bit easier and accept the help of his son when gardening.

After a further 6 weeks on stable dosing, pain intensity has declined but the patient is reluctant to reduce his analgesic medication (fearing a return of the pain) which is maintained for another 6 weeks. Winter is nearing and there is less to do in the garden. The physician suggests back training over the winter with the clear goal to try to reduce opioid treatment in a couple of months if there is progress.

What dose this and many similar cases tell us about patients' perceptions? Do patients perceive improvement/worsening of pain but not the quality of life changes? Maybe it is more complicated and is associated with our general perception of gain and loss. Generally, a loss or in other words a negative impact (e.g., loss of function, pain) appears to be perceived more acutely than a gain (improvement of function, reduction of pain); in addition, we get used to changes over time. In our specific case, an achieved pain reduction defines the patient's new 100% level and a gain of function will let him forget the previous impairment. The subjective quality of life hence adapts to this and is still perceived as ‘bad’ until somebody (e.g., the physician) helps to reflect on it (pain or function) by casting a more ‘objective’ view of the overall situation. This in turn and in a paradoxical way improves the subjective quality of life.

Thus, it is very important to define realistic treatment goals, in particular regarding short-term pain reduction and also complete pain reduction (which is - in most cases - an unrealistic treatment goal) and loss and gain of function and quality of life.

If the pattern illustrated by the patient case is a typical phenomenon in daily clinical practice often recognized by pain specialists, can we see this in clinical data and documentation?

Association between pain relief & improvements in daily functioning & quality of life

A possible association of pain relief and aspects of patients' quality of life and well-being in cLBP treatment can be investigated by analyzing studies with any pain medication regardless of its mode of action. Based on his involvement and thus familiarity with the data, the author chose four prospective, non-interventional studies (NIT) with similar study design and outcome parameters conducted between 2010 and 2013 in German routine clinical practice [21–24]. All studies used the prolonged release formulation of the atypical opioid tapentadol HCl as pain medication. The characteristics of the four observational studies are shown in Supplementary Table 1. Although medical specialization of the participating physicians differed, the patient cohorts of the four studies had similar baseline characteristics. The mean age was over 60 years, and the proportion of females was about 60%. The majority of patients (>80%) suffered from cLBP (mainly mixed pain); pain intensity was high. The case report forms of three of the studies (NIT 1–3) were identical regarding questions about pain intensity during the last 3 days, quality of sleep, quality of life, social activities, independence and libido (all during the last 4 weeks). Questions were rated on an 11-point numerical rating scale (NRS) from 0 = no pain/no impairment to 10 = worst imaginable pain/impairment. Three of the studies (NIT 2–4) employed specific questionnaires regarding functioning and quality of life (Supplementary Table 1). Generally, pharmacological interventions provide a positive outcome for the majority of the patients. This was also observed with these clinical data. Reductions in pain intensity were accompanied by improvements in sleep, daily functioning, quality of life and libido in NIT 1–3 after 3 months of treatment (Supplementary Table 2), and further improved markedly after 12 months (NIT-2). Pain reduction was also accompanied by improvements in daily functioning such as the ability to bend/kneel, to do the shopping, to perform leisure activities, or with regard to carrying out personal hygiene (NIT-4, Supplementary Table 3). These results were confirmed by the results of specific questionnaires: both functional capacity and quality of life had improved after 3 months of treatment (Supplementary Table 4) and further improvements were again observed after 12 months (NIT-2). In all studies, physicians and their patients jointly decided on an individual – realistically achievable - treatment goal in addition to a pain relief goal. Choices of aspect areas are shown in Supplementary Table 5. Rating options at the end of observation were ‘much better than expected’, ‘better than expected’, ‘as expected’, ‘worse than expected’, and ‘much worse than expected’. The majority of patients attained their individual treatment goal. Again, further improvements were observed under longer term treatment.

The most notable observation of this data analysis were interesting differences in the attainment of pain intensity and individual additional treatment goals despite corresponding improvements in pain intensity and changes in quality of life (Supplementary Tables 2 & 3). At the end of the study periods, 36–70% of the study participants reached their pain intensity goals whereas 68–96% achieved their individual treatment goals (NIT-1 to 4 combined). Also, quality of life improved markedly (NIT-2 to 4 combined) and the combined response rates were 69 to 92%. This emphasizes that patients require other factors besides pain relief in order to experience an improvement in quality of life.

How do these results relate to our typical patient with cLBP described above? The results reflect that patients' expectations regarding pain relief in these studies just like in the typical patient case might have been too ambitious, whereas the predefined additional goals were more realistic. The typical patient described above is not satisfied with his pain status after 3 months of treatment, however, he acknowledges that his additional function-related treatment goal has been achieved. Thus, the overall situation after discussion/reflection of the current status (as indirectly done by completing the questionnaires in the studies or discussion with the physician in the above case) shows that patients achieved more than reduction of pain intensity alone implied. This shows the relevance of individual treatment goals, especially, if patients tend to ‘sacrifice’ the achieved pain relief for the sake of functional improvements and it leads us to the general wish to understand what is really important for each individual patient. Thus, generally in pain practice we have to look beyond pain and have to discuss and clarify the individual priorities with the patient and define at least one realistic additional treatment goal with the overall treatment target of reducing pain to an acceptable level while improving the patient's overall situation by achieving another treatment goal such as e.g., reduction in functional impairment. A helpful question for the doctor in this context could be: “If I could change just one thing for you besides pain reduction – what should that be?”. In order to provide physicians with guidance regarding potentially relevant treatment goals for the patients, an online patient research survey of patients with chronic back pain was recently conducted to inquire which quality of life aspects are important to these patients.

Important aspects of the well-being of patients with chronic low back pain: an online patient research survey

In order to understand which treatment goals besides pain relief (functioning and quality of life aspects) are most relevant to the individual patient, a so far unpublished online patient research survey was conducted in Germany with the support of DocCheck Research (Cologne, Germany). The company randomly recruited a sample of patients with chronic back pain from their online panel population. A brief survey summary is provided here; for more details, please see section II of the supplementary material. Although online surveys are economical, easy to administer, time-efficient, offer wider reachability and use standardized methods allowing uniformity of questions enquired of all patients [25,26], limitations due to the self-reporting of data (recall error or other response bias) and the fact that only internet users could participate need to be considered. A total of 2900 patients were invited via email, 1030 agreed to participate (responder rate 35.5%). Eligibility criteria were age (≥40 years and ≤70 years), back pain ≥3 months (either in the low back or neck or in the thoracic spine region), and self-reported pain intensity ranging from 5 to 10 (on a numeric rating scale ranging from 0 [no pain] to 10 [worst pain imaginable]). The screening questionnaire is shown in Supplementary Table 6.

Survey questions were developed based on a health-related quality of life questionnaire, the SF-12 (German version [27]). Besides its frequent use in German clinical practice, this questionnaire was chosen because it had been employed in three of the four clinical studies described above. The SF-12 asks about the physical and mental health of patients and comprises 12 questions from the eight domains physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. These domains are equal to the domains of the SF-36 [28]. As the survey was not intended to evaluate the quality of life status of the participants but was carried out to understand which areas investigated by the SF-12 are most relevant to them, the SF-12 domains and not the single items were used. In addition, the survey included questions about sleep and sexuality, both deemed important aspects of patients' well-being not captured in the SF-12/SF-36. The survey was conducted in German. As the original SF-12 domain names are rather technical, lay form descriptors were used to allow the respondents a better understanding of the domains. A more detailed description of the questionnaire can be found in the Supplementary Method text and Supplementary Tables 6 & 7.

A total of 300 respondents completed the survey and were included in the analysis. Chronic back pain among adults in Germany increases with age and is significantly more prevalent among women than men [6]. Gender is thus an important factor for the potential generalizability of the survey findings. Mean age (SD) of survey respondents was 57.4 ± 7.4 years, 61% were female. Most patients (90.3%) suffered from lower back/lumbar spine pain. A pain intensity of ≥7 on the 11-point numerical rating scale was reported by 59.3% of the respondents, and 75% had a pain duration of more than 5 years. Supplementary Table 8 provides detailed sociodemographic data.

As expected, pain reduction was considered the most important treatment goal: 46% of respondents stated ‘being pain-free’ and 40% mentioned ‘general pain relief’ (unprompted question; Supplementary Figure 1). However, ‘mobility’ was also deemed strikingly important (21.3%). This is underlined by the ratings for the SF-12 aspects where over 45% of respondents identified ‘fewer physical limitations during moderately difficult activities/movements’ (46.7%) and ‘fewer limitations in everyday activities and at work due to my pain’ (45.3%) as one of their top three preferences (Figure 1). In addition, almost three quarters of respondents (70.7%) considered ‘improvement of my general health’ as one of the top three treatment goals (Figure 1). This combination of preferences is not surprising given the often significant impact of cLBP on functioning in daily life. The SF-12 domains associated with physical health-related components were rated as the top three goals regardless of age, pain intensity or gender (Supplementary Table 9).

It should also be noted that respondents placed high importance on ‘improvements in sleep quality’ and ‘fewer restrictions on my sexuality’. The majority of respondents (92.4%) considered improved sleep and half of them (50.7%) ‘fewer restrictions on my sexuality’ as at least of equal importance as the top three SF-12 dimensions. The survey documented that the latter aspect in particular is neither discussed with the physician/nor considered in cLBP therapy (75%; Figure 2) although LBP affects sexual functioning [29], and health satisfaction for men is significantly associated with ‘satisfaction with one's sex life’ [30]. In fact, one in four male respondents (26.5%) considered ‘experiencing fewer sexual restrictions’ as more important than their individual top three SF-12 domains (Supplementary Table 9).

These survey results show the significance of health-related quality of life aspects for patients in the treatment of cLBP. Besides pain reduction, mobility, physical functioning, better sleep and a better sex life seem to be the most important aspects which should be touched upon by the physician when exploring treatment goals and expectations with medical care with each individual patient.

Discussion

In clinical practice, a clear and trusting communication between patient and healthcare provider is essential in the process of finding a suitable treatment for each individual patient with chronic low back pain. Long trial and error periods with different nonpharmacological and pharmacological pain therapies are common for this patient group, so are increasing functional impairments, the development of comorbidities and decreasing quality of life. In cLBP, pain relief is the primary treatment goal for patients, as pain is the main problem of the indication. It is, however, important to identify the most important effects of the pain on the individual patient and thus to recognize the individual goals. Understanding these aspects will help to measure whether a treatment improves the patient's life. In particular better mobility or increased functioning in daily life might be more important for some patients and they are prepared to forgo optimal pain relief for a better quality of life. Besides the overall treatment goal of reducing pain to an acceptable level, physicians should discuss at least one additional realistic treatment goal with patients.

Defining goals for treatment means defining what is considered treatment success. Joint definition of goals and joint decision making not only forms the very basis of a trusting relationship and a move from a frequently found expert`s attitude of “I know what is best for you” to “we will find out together what is best for you”, it also introduces objective and individualized parameters beyond pain relief which can be re-evaluated during the course of treatment. And, certainly, a treatment concept also should be changed or stopped if the goals were missed.

Frustration is often the result of wrong expectations and these wrong expectations in turn may often be related to patients and physicians giving different priorities to treatment goals. In a US survey, patients and physicians ranked different goals of chronic pain management; whereas almost 50% of the patients gave top priority to the reduction of pain intensity (which is not surprising with a mean pain intensity of 7.6/10 in the survey population), more than 40% of the physicians rated improved function as top priority, ranked minimization of side effects high (26%), and less than 10% gave top priority to the reduction of pain intensity [31]. The online patient research survey in Germany described above yielded similar results concerning pain intensity: being completely pain-free and general pain relief were considered the most important treatment goals by 46% and 40% of the patients, respectively. These divergent expectations of patients and physicians in the US survey and unrealistic expectations in the German survey may lead to dissatisfaction with treatment on the patients' side unless a trusting communication with the doctor allows for an adjustment of beliefs and a realistic expectation concerning the future pain reduction. It has been demonstrated for patients with LBP that healthcare professionals have a considerable impact on patients` attitudes and beliefs [15,32].

The goals agreed upon after joint decision making should encompass reduction of pain and improvement of pain related impairments such as functioning. In addition, these goals should be realistic, specific, measurable and documented. Patients differ with respect to their circumstances, preferences and expectations thus treatment goals need to be highly individualized. This may be a general goal such as to be able to bend, kneel, or stoop or specific goals concerning independence with regard to washing or getting dressed, shopping, performing certain leisure activities, being able to get into a car or walk stairs again or may refer to mental aspects like being less depressed by pain and impairments. A practical way forward is to gain trust, inquire about the personal circumstances of the patient, inquire what is important for him/her and discuss how this can be achieved. As shown by the results of the non-interventional studies, the chances of pain management achieving individual treatment goals are high (68–96% achieved their individual treatment targets). By contrast, expectations regarding reduction in pain intensity might have been too high with 36–70% of the participants achieving this goal. This is very much in line with data in the literature, with many studies showing that patients expected a substantially larger reduction in pain from treatment than they actually achieved [33]. This stresses the point of defining realistic goals, also and in particular for the reduction of pain.

After an initial decision on and documentation of defined goals and treatment approach, the pain situation of a patient with cLBP is likely dynamic. The initial severe pain requiring opioid treatment may be reduced to a mild to moderate level, the patient may generally not be as functionally disabled thus regaining a certain degree of independence, fulfilment and participation in social life. All of these improvements may in addition have positive mental effects. Although nearly 50% of the respondents of the German online survey rated functional impairments as most significant, almost 30% also reported mental effects of chronic back pain (being discouraged/sadness). However, these initial improvements are also perceived by the patient as the new 100% level, i.e., any further improvements and deteriorations of the current status will be compared with the newly achieved level (e.g., a pain level of 4 vs 7 at the start of treatment, functional ability vs disability at the start). This perception leaves less room for improvement whereas deteriorations are taken badly by the patient. Thus, as described in our typical case, the patient may return to the consultation and be dissatisfied with his/her current treatment owing to recurrence/deterioration of pain or unfulfilled expectations concerning further improvements. During this consultation the patient's subjective perception may be counterbalanced by the physician's objective documentation of the original status. This allows for a ‘reset’ to the original perceptions, in other words a gentle reminder of what it used to be and what goals had been agreed upon and were in fact achieved, an analysis of the potential reasons for deteriorations, and joint decision making for the next steps to take. Thus, a switch or increased dose of medication is not necessarily the answer to the current problems but good and trusting communication and joint decision making in a patient-centered approach may help the patient to reflect and support coping. Chronic pain is associated with the perception of loss, and emotions associated with loss are similar to those of bereavement [34]. Supporting the patient by discussing these losses may help to change beliefs and acknowledge gains. Although helpful, delivery of information alone has been shown to be insufficient for successful low back pain therapy [35].

In summary and as a suggestion, at the start of treatment it is helpful and necessary to define jointly some treatment goals for the next 3 to 6 months. After that time the achievements should be discussed, and a change of treatment should be made if necessary. This could be a change of the medication or a switch within the same medication class or the addition of other approaches (psychological, physiotherapeutic, social changes) or even the elimination of negative factors (being definitively overburdened, changes in the job etc.) and reduction of medications.

The clinical data used to support the author's observations were from analgesic studies with an atypical opioid. Opioid use for severe cLBP is not uncommon. There is a general perception that once a patient receives opioids, he/she will stay on opioids. But is this necessarily so? Opioids are often required for initial pain relief in cases of severe pain and for those 60% of chronic back pain patients in the online survey who reported pain intensities of ≥7 (11-point numerical rating scale). The utmost initial goal is likely reduction of pain to a bearable level. However, reduction of opioid dose or switch to milder analgesics might be possible under the following circumstances: i) pain reduction has enabled the patient to be more mobile, ii) the patient has been enabled to strengthen muscles, undergo physiotherapy, and potentially initiated some changes in lifestyle and behaviour, iii) the patient has accepted that reduction of pain is likely a more realistic treatment goal than complete elimination of pain. In fact, regular joint re-evaluation by clinicians and patients concerning the benefits and risks of continuing opioid therapy is recommended by guidelines [36–38]. Again, it all depends on pain management tailored to the individual patient, joint decision making in defining realistic treatment goals, a good physician–patient relationship, trust and time. Tapering of opioids should ideally proceed slowly to a) avoid as far as possible opioid withdrawal symptoms and signs, and to b) accustom the patient to an initial period of increased pain which is likely to diminish over time [38]. Tapering of opioids in patients may lead to improvements in pain, function and quality of life [39]. Thus, back to our original question whether opioid treatment is for life once it has been initiated, it can be stated that tapering of opioids is not only possible but should potentially also be envisaged and discussed with the patient right from initiation of the drugs.

Conclusion

A good understanding between physician and patient is an important if not the most important aspect in the management of pain. It is the basis for an essential joint definition of realistic therapeutic goals and their achievement. Raising specific questions during consultation can help both physician and patient to reflect on and recognize what effects of the pain and impairments related to the pain are important for the individual patient. On the basis of this, the most essential treatment goals for each patient can be identified. Besides pain reduction, improved mobility, seems to be of particular importance for many patients with chronic low back pain. This finding did not come as a surprise, since mobility stands for independence, integration and both physical and social function. Suggestions for questions which are helpful in this individualized approach are proposed in this paper.

Future perspective

In clinical practice, for some patients, pain relief is the most valued treatment goal, however, other patients seek more mobility/functioning and are prepared to forgo optimal pain relief for a more active lifestyle important to their quality of life. In addition, treatment goals are likely to change even in an individual patient once e.g., the initial unbearable pain has been reduced. Thus, chronic back pain management requires a highly individualized treatment approach, and awareness of the treating physicians for these different treatment goals needs to be raised and reconciled. These aspects should also be taken into account in future clinical trial designs when investigating analgesics for chronic pain treatment. Trial end points need to be carefully defined to understand pain relief in the context of mobility and quality of life in order to identify treatments that meet patients' expectations. Parallel but separate determination of these outcomes is recommended. The concept of individual treatment goals also needs to be integrated in medical training and further education in pain management. In addition, the development of new quality of life questionnaires should consider the topics ‘sleep quality’ and ‘impairment in one's sex life’ for a more comprehensive quality of life assessment in further studies.