http://informahealthcare.com/dre ISSN 0963-8288 print/ISSN 1464-5165 online Disabil Rehabil, 2014; 36(20): 1713–1722 ! 2014 Informa UK Ltd. DOI: 10.3109/09638288.2013.869625

REHABILITATION IN PRACTICE

The perceptions of people with low back pain treated in the Spanish National Health, and their experience while undergoing a new evidence-based treatment. A focus group study Alejandra Cano1, Mario Gestoso2,3, Francisco Kovacs2,3, Claire Hale4,5, Nicole Mufraggi2,3, and Vı´ctor Abraira1,2,6 1

Unidad de Bioestadı´stica Clı´nica, Hospital Ramo´n y Cajal, IRYCIS, Madrid, Spain, 2Spanish Back Pain Research Network, Palma de Mallorca, Spain, Fundacio´n Kovacs, Palma de Mallorca, Spain, 4Dame Kathleen Raven Professor of Clinical Nursing, School of Healthcare, University of Leeds, Leeds, West Yorkshire, UK, 5Academic Unit of Musculoskeletal Nursing (ACUMeN), Leeds, UK, and 6CIBER Epidemiologı´a y Salud Pu´blica (CIBERESP), Madrid, Spain

3

Abstract

Keywords

Purpose: To explore the perceptions of people with low back pain (LBP) treated within the Spanish National Health Service, and their experience while undergoing a new evidence-based treatment (‘‘neuroreflexotherapy’’). Methods: A focus group (FG) study was conducted. Participants were divided into five groups according to whether they: suffered from subacute versus chronic LBP; had undergone one versus several neuroreflexotherapy procedures; showed a clinically relevant improvement in pain and disability according to validated measuring instruments, and reported it. Thirty-two patients were selected by purposive sampling. Content analysis was undertaken by two researchers who had no contact with the clinicians. Results: Subacute and chronic LBP curtails daily activities, reduces quality of life (QoL) and self-esteem, and is experienced as a stigma. Patients want to be treated with respect and empathy by clinicians who refrain from judging them. New treatments trigger hope, but also fear and mistrust. Most patients experiencing a clinically relevant improvement resume daily activities, and report improvement in QoL, self-esteem and emotional wellbeing. Conclusion: Southern European LBP patients have similar perceptions to those in other cultural settings. LBP jeopardizes patients’ QoL and self-esteem. When pain improves significantly, patients are happy to acknowledge it and resume their normal life.

Clinical progression, low back pain, neuroreflexotherapy, patient’s perspective History Received 23 January 2013 Revised 20 November 2013 Accepted 22 November 2013 Published online 24 December 2013

ä Implications for Rehabilitation    

People with low back pain (LBP) want to be treated with respect and empathy by clinicians who inspire confidence and refrain from judging them. When faced with a new evidence based treatment, people with subacute and chronic LBP are hopeful, but apprehensive. Most of those who experience a clinically meaningful improvement after treatment are happy to acknowledge it and resume an active and fulfilling life. People who report no improvements after being treated, should be believed.

Introduction Nonspecific or common low back pain (LBP) is defined as pain between the costal margins and the inferior gluteal folds, which is usually accompanied by painful limitation of movement and may be associated with pain referred down to the leg (‘‘leg pain’’) [1]. Diagnosing common LBP implies that the pain is not related to conditions such as fractures, spondylitis, direct trauma, or

Address for correspondence: Francisco Kovacs, Departamento Cientı´fico Fundacio´n Kovacs, Paseo de Mallorca 36, E-07012, Palma de Mallorca, Spain. Tel: +34971720809. Fax: +34971720774. E-mail: fmkovacs@ kovacs.org

neoplastic, infectious, vascular, metabolic, or endocrine-related processes [1]. LBP represents a major health care, social and economic burden, especially when subacute or chronic [1–7]. Previous qualitative studies in the Anglo-Saxon and Northern European cultural contexts suggest that people with chronic LBP experience their condition as a stigma and perceive themselves as a burden for others, which can lower self-esteem and lead to depression [8–15]. However, certain psychological variables which are important for people with LBP in these cultural contexts, such as fear-avoidance beliefs and catastrophizing [16–23], have shown to be irrelevant in Southern Europe [24–31]. These differences might suggest variations in the experiences of LBP across these cultural settings. However, to date, no qualitative studies have focused on Southern European LBP patients.

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The expectations elicited by new treatments can contribute to restoring hope among people with subacute and chronic LBP, which is helpful [15]. However, the disappointing clinical evolution experienced by such patients, characterized by failed treatments and persistent pain, increases catastrophizing and may lead to mistrust towards any additional treatments and loss of hope [31]. Therefore, the experience of subacute and chronic LBP patients when undergoing a new evidence-based treatment should be explored, in order to gain some insight into how these patients cope with both the success and failure of the treatment. According to the corresponding Cochrane systematic review [32] and to the evidence reviews supporting European and US evidence-based clinical guidelines [33,34], neuroreflexotherapy intervention (NRT) is one of the few treatments for subacute and chronic LBP which is supported by high quality evidence on efficacy and effectiveness [32,35–39]. It consists of implanting surgical staples and other surgical devices in specific trigger points [32,35–37], which is believed to deactivate mechanisms involved in perpetuating pain, neurogenic inflammation, and muscle dysfunction or contracture [32,35–37]. The procedure is unrelated to acupuncture, and the accuracy of the location where the material is implanted is essential: the insertion within a 5 cm radius of the target zones has been used as a ‘‘sham’’ procedure in randomized controlled trials (RCTs) and shown to have virtually no effect [32,35,36]. NRT is conducted without anesthesia and the material is extracted approximately 90 d later, although some patients need more than one intervention to reach the maximum possible sustained improvement [37,39,40]. In routine clinical practice in the Spanish National Health Service (SNHS), NRT has shown to trigger a clinically meaningful effect and to be associated with a better prognosis [32–34,37–41]. However, although NRT is currently in the process of being rolled out within the SNHS, it is not yet available everywhere [32,38–40]. Hence, it is still perceived as a ‘‘new’’ treatment by most patients and clinicians. Therefore, the objectives of this study were to explore the perceptions of people with LBP treated within the SNHS, and their experience while undergoing neuroreflexotherapy.

Materials and methods Study design The nature of the research question and the exploratory purpose of this study, suggested a qualitative methodology. The study design followed a critical realist paradigm of enquiry because this privileges the voice of the patients when describing their experiences. A qualitative focus group (FG) study was conducted in certified NRT units treating patients referred from the Spanish National Health Service (SNHS) in the Balearic Islands. In the FGs, patients’ views were gathered with the purpose of obtaining their insights into the experience of living with LBP and undergoing NRT. FGs are group interviews on a specific topic that seek to generate qualitative data by capitalizing on group interaction [42]. Unlike individual interviews, FGs offer opportunity for debate and discussion, which allows participants to influence and be influenced by other group members and the environment, and helps all relevant aspects with regards to their experience to surface [43]. Informants Forty patients selected by purposive sampling, were invited to attend the FGs. Purposive sampling was used in order to include patients who had experienced the widest possible array of different experiences. Eight participants declined to attend

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Table 1. Characteristics of patients who participated in the study. n ¼ 32

Variables a

Gender (male) Age (years)b Employment statusa Active Sick leave Retired Housewife Duration of the pain episode (days)b Duration of the pain episode (days) categorizeda Subacute (14–90 d) Chronic (490 d) Have undergone failed back surgerya Baseline severity of LBP (VAS)b Baseline severity of LP (VAS)b Baseline disability (RMQ)b Severity of LBP at discharge (VAS)b Severity of LP at discharge (VAS)b Disability at discharge (RMQ)b

10 (31.3) 58.5 (50.5; 64.5) 14 2 9 7 150.0 10 22 5 7.0 5.5 11.0 0.5 0.0 4.0

(44.8) (6.3) (28.8) (22.4) (77.5; 365.0) (31.3) (68.7) (16.0) (6.0; 8.0) (3.0; 8.0) (9.0; 13.7) (0.0; 3.7) (0.0; 1.0) (0.0; 8.7)

a

Frequency (%). bMedian (P25; P75). LBP, severity of low back pain; LP, severity of pain referred down to the leg, among those who reported it (n ¼ 26); VAS, Visual Analog Scale (range from better to worse; 0–10); RMQ, Roland-Morris Questionnaire (range from better to worse: 0–24).

because of their work schedule, family commitments, or because of unrelated health conditions (one from FG 3, two from FG s 1 and 4, three from FG 5). The thirty-two participants who accepted were recruited, and none were excluded. Tables 1 and 2 show patients’ characteristics. Inclusion criteria were being born and raised in Spain; being 18 years or older; having been referred for NRT intervention according to the validated indication criteria; having undergone NRT intervention during the previous year; and signing the informed consent to participate in this study. Validated indication criteria for NRT are; LBP not caused by trauma or systemic diseases, lasting 14 or more days with a severity 3 points on a visual analogue scale (VAS) [45], except patients with neurogenic claudication caused by spinal stenosis and those with cauda equina syndrome [32,35–40,44]. Exclusion criterion was suffering from clinically relevant hearing loss. Focus group interviews Following best-practice guidance from Krueger and Morgan [43], audio-recorded FGs interviews lasting 1.5 h, were held. In order to gather sufficient data to answer the research questions, five groups were established, with five to eight participants each [43,46]. The design of the FGs was based on the inputs from two clinicians with over 20 years of experience in performing NRT interventions, who also were major researchers in the field of LBP, and on results from previous quantitative studies [32–40]. These sources concurred in suggesting that five types of participants might be recognized, depending on whether their pain was subacute or chronic, had experienced improvement after undergoing NRT, had been previously treated with this procedure, and had undergone previous spine surgery. Therefore, it was considered that information from the 32 participants in these 5 FGs would provide a comprehensive overview of the range of patient experiences (Table 2). Participants were considered to have experienced improvement when: (a) they reported having perceived a relevant improvement and (b) their scores for pain and disability showed a clinically relevant improvement (i.e. 30% of the corresponding baseline

Perceptions of S. European LBP patients

DOI: 10.3109/09638288.2013.869625

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Table 2. Characteristics of patients included in each focus group.

Participant 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32

Gendera

Age (years)

Focus group

Duration of the pain episodeb

F M F F F M F F M F F F M F M M F M F F F M M F F F F F F F F M

59 72 64 75 65 54 58 51 36 77 41 52 63 53 54 61 43 45 39 63 60 74 51 44 59 65 41 77 62 76 56 50

1 1 1 1 1 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5

S S S S S S C C C C C C C C C C C C C C C C S S C C S C C C C S

Improvement after NRTc

Not Not Not Not Not Not

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes perceived perceived perceived perceived perceived perceived No No No No No

History of previous NRT

History of spinal surgery

No No No No No No No No No No No No No No Yes Yes Yes Yes Yes Yes Yes No No No No No No Yes No No No No

No No No No No No No No Yes No No No Yes No No No No No No Yes No No No No No Yes No Yes No No No No

a

F, female; M, male. S, subacute; C, chronic; S/C, either subacute or chronic. c ‘‘Not perceived’’: Despite participants reporting no improvement, validated instruments for measuring pain and disability showed improvements which were above the cut-off values for clinical relevance. b

Table 3. Illustrative examples of questions included in the focus groups.

Procedure

1. How would you describe the impact of low back pain on your daily routine? 2. How did LBP limit your ability to follow through with normal daily activities? 3. What kinds of treatments have you received for your LBP? 4. How have the different treatments you have received made you feel? 5. In what ways do you feel the treatments received have helped or harmed you? 6. What were your expectations on NRT when you were referred for the procedure? 7. What is your opinion on NRT, after having undergone it? 8. What advantages and downsides does NRT have in comparison to other treatments? 9. In a scale of 0 to 10 (where 10 represents highest level of satisfaction), how would you rate your level of satisfaction with NRT? 10. Which characteristics of NRT do you value the most (effectiveness, duration of the effect, availability through the National Health Service, safety, etc.)?

The study design was approved by the Ethical Committee of the Spanish National Health Service in the Balearic Islands (Ref. number: lB 1261/09), and all patients gave their written informed consent. The fully informed consent form was signed voluntarily. It included clauses guaranteeing confidentiality and anonymity of the data collected. Clerical personnel not related to the research staff, used the NRT registry to identify patients who complied with the following three criteria: having received NRT during the previous year, having been discharged, and complying with the inclusion criteria for each group. The NRT registry includes all patients referred for NRT and gathers their social, demographic and clinical characteristics, their use of health resources and their clinical progression measured through validated instruments (e.g. pain, disability and patients’ subjective perception of their progression) [38–41,45,47]. It has shown to be reliable and comprehensive, with less than 5% losses to follow-up [38–41]. Clerical personnel contacted eight patients per FG, and invited them to participate in a study designed to gather their perceptions about LBP and NRT. Patients who had been discharged last were contacted first. The FGs were conducted by an expert in qualitative research (A.C.), who only had contact with the patients during the FGs; in fact, she resided in the mainland and travelled to the Balearic Islands specifically to conduct the FGs, on the days in which they took place. The FG interviews took place

value, with an improvement  1.5 points in a Visual Analog Scale –VAS- for pain, and 2.5 points in the Roland-Morris Disability Questionnaire – RMQ-) [44,47–49]. The cut-off limits for subacute and chronic patients were set at 14 and 90 d [50,51]. Table 2 shows the characteristics of patients included in each FG, and Table 3 shows examples of some of the questions raised in the FGs.

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with an observer present. The first author moderated all discussions, using a semi-structured interview script, while the observer took written notes recording nonverbal information, interaction between participants and the strength of any emotional responses [52]. The discussion topics for the groups were adapted during the course of the research in response to emerging themes. After each focus-group interview, the interviewer and the observer shared their perceptions on group interaction and its significance for the analysis. A brief discussion between them at the end of each FG interview, offered the opportunity to identify any potential threats to validity, such as the mechanisms underpinning both successful and unsuccessful experiences. Data analysis The analysis of the data was inductive. At the end of each FG interview, researchers took brief notes on emerging themes, offering some insight into whether data saturation had been reached [53]. Analysis was based on full transcripts, as it is considered to be the most rigorous approach [43]. Audio recordings were professionally transcribed verbatim, and transcripts were checked against the recordings line by line. Transcripts were compared with the comments and notes of the observer. Data were found to be consistent in quality and content, irrespective of the medium or source. Subsequently, all data were pooled and treated equally. Individual comments were treated as a product of the group, rather than of an individual [52]. Interactions between participants and any potential effects imposed on the data by the researcher [54] were incorporated into the transcripts in italics. This arrangement enabled all data to be amalgamated into one primary data source. Content analysis, including the steps of coding, categorizing and identifying themes [55] was undertaken by two researchers. The researchers reviewed the differences in coding and resolved them. During this process, attention was paid to exceptions in the data, and any emerging explanation was revised in the light of contradictory cases [56]. Quotations were used to illustrate and reflect responses from the participants. Quotes were selected based on the criteria that they should: illustrate the category of meaning sufficiently; add a new perspective; and represent the opinions of different participants. Quality criteria The criteria defined by Lincoln and Guba (credibility, transferability, dependability and confirmability), were followed [57]. Analyst Triangulation was performed for credibility purposes; participants’ feedback (‘‘checks’’) was sought in order to confirm that data gathered accurately reflected their experiences. In order to increase transferability, purposive sampling technique was used, findings were presented comprehensively and quotations from the participants were included. In order to address dependability, a researcher not involved in the research process acted as an external audit, and reviewed the process and output of the study. To enhance confirmability, the author who conducted the FGs (A.C.) had no clinical experience in the field of LBP, lived in a region where NRT had not been rolled out, neither she nor her relatives had undergone NRT, and had no contact with the clinicians involved in performing the procedure. To ensure that she did not have any relationships with the patients which might have influenced their answers, at the design phase of this study it was established that any patient with such a relationship would be excluded.

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Results Ten topics were identified during the qualitative data collection and analysis processes. The experience of suffering from LBP in Spain Suffering from subacute or chronic LBP has a dramatic impact on persons’ daily activities and quality of life (QoL). People with chronic LBP perceive themselves as a burden for others, which reduces self-esteem and leads to depression. This is more frequent among females because many feel that their role in society is to act as carers. Going from care-giver to care-receiver generates feelings of guilt. Informant N 31: I became unable to do what I was used to doing before. I used to take care of the house, and now someone else has to do everything for me. I don’t feel comfortable with this situation. I feel I am not fulfilling my duties. People with chronic LBP, who have undergone treatments for years and failed to improve, feel they are condemned to live with constant pain forever. Some subjects acknowledge needing psychological or psychiatric support. Informant N 14: When I had such intense pain, I used to say ‘‘wait a minute, if you can put down an animal when it is suffering, do the same thing for me, I can’t bear this’’. This is what I was thinking, kill me, I wanted to die because I couldn’t bear it. Informant N 25: You end up thinking, Jesus, with everything I’ve managed to do in this life, this is what I have to put up with for the rest of my life! And I’ve still got so many years ahead of me. Can you imagine what it’s like to live with this? I have to go to the psychiatrist or something, because I don’t know how I’m supposed to handle this kind of life. Do you understand me? The fact that LBP cannot be spotted by anyone but the sufferer, leads them to think that others do not understand their experience and perceive them as weak people who constantly complain. They experience their condition as a stigma. Informant N 9: It gets to a point when everyone around you knows you have back pain, and talks about it. And this is a bit . . . its not that it stigmatizes you, but almost. Informant N 17: It’s just that everyone is used to you doing your part, but when you can’t, they think its ‘cos you’re being lazy, that you don’t . . . when someone is missing a leg, they’re a cripple, but this is something you can’t see, and it looks like there’s nothing wrong with you. The experience of being treated for LBP in Spain In their quest for an effective treatment, people with chronic LBP are intensive users of the health system, and have spent years being passed on from clinician to clinician. Informant N 25: Is there anyone to take care of me? I’m looking for a sense of humanity, a sense of care. I’m not going to see the doctor ‘cos I’ve got nothing else to do; I want them to tell me, listen here, if you do this, you might feel better. I’ve seen a thousand doctors in private practice and the National Health Service. One says I shouldn’t even think about going for surgery, another one says that unless I go for surgery, I will never get cured, another one tells me to try rhizotomy, to try

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other things, but what are we here for? Shouldn’t they be looking at our records and coming to an agreement? Recommendations offered by different specialists are inconsistent or contradictory, especially with regards to surgery. This raises suspicion among patients and pushes them to keep searching for more opinions and exploring other treatments. Informant N 7: Massage don’t make a real difference, because it is only that moment; you are only better for a while. Informant N 14: With rehab, during the 10 to 15 minutes it lasts you feel a little bit better, because they used to give me massages, electrotherapy and all that . . . Informant N 24: On top of all the risks you run, there is not even a guarantee that after the operation you’ll go back to normal activity, so I’m really not convinced. Informant N 29: . . . I rather continue suffering from pain than go through an operation. ‘Cos if they mess it up, then you really don’t have a solution. People with LBP think that the staff to patient ratio and the technological resources available are better within the National Health Service than in private practice. However, when the treatments offered in the National Health Service do not work, people who can afford it resort to private practice or alternative medicine. The main advantages they attribute to private practice are short waiting times and comfort, although they suspect that, in that setting, financial incentives may influence clinical practice. Informant N 1: The thing is that you prefer private practice because they see you quicker. My parents are elderly, and in private care, there is a spare bed so you can stay with them, they get a room for themselves, there are chairs, . . . and in the National Health Service you have to spend the night sleeping on a chair, and comfort is what you rate right? But then again, they cut staff. Informant N 3: And the private insurance I also have . . . , private doctors keep trying to do all kind of things to me. And they convinced me to undergo rhizolysis. And they did give me one, and I didn’t feel anything. It didn’t do anything for me. And they wanted to convince me to get epidural injections, and said no. Informant N 5: I’ve got private insurance too and what I see is that they try to do everything to you, I guess so they can get more money out of the insurance company. I try to keep away if I can, because once I got a pain in my back, they took an x-ray and they wanted me to spend the night there, and I said no way, and he kept saying ‘‘yes, yes, you need to stay, here we’ll be able to keep the pain under control’’. And I kept saying ‘‘no way’’, and he kept saying ‘‘oh yes you will’’. And I said ‘‘I need to get back home’’ and again ‘‘no you won’t’’. The more he insisted, the more I sobbed and worse I felt. He didn’t manage to convince me, I refused to stay overnight ‘cos of backpain. Informant N 20: I spent tons of money on chiropractors and that was useless. A year and a half; initially twice a week, then once, and eventually once every three weeks, but then I stopped going, I got fed up with spending money and not getting any solutions. Seeking empathy and understanding from healthcare professionals People with LBP are well informed about all kinds of treatments, so when they do not find a solution, they feel disappointed, ignored, and often sense that clinicians are demonstrating a lack

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of respect and empathy. Patients want practitioners to respect them, inspire confidence and to not judge them. They value the effectiveness of the treatments they receive, but they also value personal treatment and the clinicians’ empathy and understanding. Informant N 8: They tell me I should lose weight. I prefer being overweight and feeling emotionally stable, to being skinny and feeling the way I was feeling, shifting from the bed to the sofa and back again like a small child. And everyone says the same thing ‘‘your weight’s the problem’’. Now I don’t even bother going any more, ‘cos it puts me in a bad mood . . . Its not that I mind being told I’m fat, I’m not stupid, I can see that I’ve put on 30 kg. The doctor who gave me NRT helped me feel more confident, he treats me really well and he took my pain away. Informant N 17: They have a way of treating patients with such empathy that in my opinion, they deserve a medal. My general practitioner told me ‘‘he’s a good doctor, I know him personally and he’s good’’. And I said ‘‘he is also a great person’’. Informant N 25: I want somebody to understand me, to explain things to me and tell me what to do, not to keep going from one doctor to another . . . to make you spend money and then say that they don’t know what’s wrong with you and that there is nothing there are no solutions for you. Informant N 29: My doctor even referred me to a psychiatrist, I guess he must have thought this women keeps complaining, maybe she is missing a screw. But I’m not crazy, I’m not going to go to a doctor and tell him that I’m in pain, there is nothing I wish more than not having pain. Referral for NRT In the Spanish National Health Service, physicians often offer NRT as a last resort to patients who have already undergone many treatments unsuccessfully. Informant N 13: My doctor told me ‘‘listen, there’s a clinic which carries out the treatment, all I can do is send you there and they will decide if it makes sense for you’’. Informant N 25: After undergoing all sorts of treatments unsuccessfully, my orthopedic surgeon told me about it. Informant N 26: Mi doctor told me; look, you have already tried everything, and nothing has worked. There is a clinic that treats you with staples, and people say it works. I am going to refer you to them to see if they can do something for you. Other people ask their general practitioner to refer them for NRT, based on what they have heard through a relative or a friend who has undergone the procedure. Informant N 12: Almost everybody with low back pain knows someone who has recovered thanks to the staples. Informant N 14: They didn’t offer me the option. They didn’t know. They did send me to have NRT, but that’s because I asked to be referred. Informant N 16: I told my general practitioner to refer me because I know three people who were worst than me and recovered really well. They believe that the reason why it took a long time for them to be referred for NRT is because most practitioners in the Spanish National Health Service are not yet familiar with it. They consider this a proof of low standards in medical care since, unless patients take it upon themselves to stay abreast of the latest

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developments and ask their clinicians to refer them, they are not going to get the treatment they need. Informant N 17: They sent me through the pain unit in my hospital, but a lot of doctors don’t know this, they don’t know about the clinic or about the treatment. Informant N 24: My doctor had never heard about NRT intervention until I told him about it. I had to ask him to refer me, and he did so without being fully convinced it was going to work. I think it is outrageous that they are not updated with regards to treatments for low back pain. Expectations raised by a new treatment For people with subacute and chronic LBP, in which previous treatments have failed, being referred for yet another treatment generates hope, but also fear, incredulity, and mistrust. Informant N 12: I wasn’t convinced about the technique, at least on my side I thought ‘‘I’ll try it out and then decide if it works’’. Informant N 18: I wasn’t very sure about it when I went, because I had tried out so many things before, I thought ‘‘ok, let’s give it a go and see what happens’’. But the truth is that it went very well. It’s what has worked best. Informant N 29: NRT was my last resort, and it has not worked for me. Yes, yes, I was happy because I said to myself ‘‘let’s see if this will bring some relief to my pain; not that it will disappear because it is impossible . . . but little bit.

Experiencing improvement after NRT Among people with LBP who improve after NRT, the most valued outcomes are resumption of normal life as pain recedes, and withdrawal from other treatments. Resumption of normal life as pain recedes Approximately 85–90% of patients improve after NRT [38–40,44]. Pain relief usually appears almost immediately after NRT [35–41]. Occasionally, it takes up to a few weeks to appear. Informant N 8: It’s a miracle. It’s like going to Lourdes. Without a doubt, the best thing I have ever tried . . . The pain was disappearing and I noticed myself relaxing, as they were putting the staples on me. The pain hasn’t returned ever since. Informant N 11: My pain started after giving birth to my daughter, about a year ago now, and I had some staples inserted and felt better straight away, I mean it was something automatic. Informant N 12: During three weeks, I kept wondering why I had bothered, ‘cos the pain was still there, but after . . . it started to fade away, it was still there but it wasn’t as painful and it wasn’t continuous. I continued to improve, they took my staples off and now I’m in heaven. Informant N 15: When I had the staples done, my leg had been numb and painful for over a year, when I was sleeping at night time, I couldn’t even hold some positions, I had to lie still. I had the staples, and the pain disappeared the next day, now they have taken the staples off and I feel fine. Informant N 16: . . . my experience was miraculous. I walked in a bent old man, and walked out straight as a young one. Informant N 17: The first time you come, you feel a bit weary but when you realize you are walking out without any pain at all, it’s something I just . . . I feel so happy . . .

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Informant N 20: The automatic effect of walking out without pain, which I’m hearing others describe, isn’t what I experienced. I started to feel the improvement the next day, that’s when the pain vanished. The improvement of pain allows people to resume their daily activities, including professional and social lives [35–41,44]. This improves QoL, emotional well-being and self-esteem. People have the impression that they have regained control over their bodies and feel confident that they can deal with their routine activities. This makes them feel that they can control their lives again, return to work, and regain their role in society, which leads to them recovering their personal identity. Informant N 7: Without a doubt, what worked for me was NRT . . . it has been . . . being able to have a decent life again. Informant N 13: . . . they gave me the treatment and bless them, because since then I have never been off work again. Informant N 14: I wanted to die because I couldn’t bear it. I’m really happy now. Informant N 15: I just wanted one thing; some quality of life. To be able to take care of myself, help out with the housework . . . since I got the staples, my pain has disappeared. I’m careful with lifting heavy things, and I try to avoid bending over. But now I do everything I can, as long as I have a quality of life, which is what I really care about, having no pain. As far as I’m concerned NRT gets top marks. Informant N 19: The most important thing for me was to be able to get back to work. Being useful again, and going back to my profession. This is really important for young people. Informant N 21: I’d never done sport in my life, but since I got the staples, and my pain has vanished, I’ve even begun doing aqua-gym, I’ve been doing sport and the truth is that now I have a normal life. Before that I used to panic before going out and walking, especially when I walked, because I broke out in cold sweats and I got dizzy. Today I’ve come here walking, in other words, even my phobia has disappeared. I feel really good, because not being able to go out alone, and having to always go with someone is awful. Some people think that if they strain themselves, pain may appear again. However, once they are pain free, most subjects simply forget they have been in pain and live a normal life, doing all kinds of things. Informant N 1: Yes, after the treatment, the improvement was very significant. I still have some discomfort when I stop being careful and start loading and unloading or doing things I shouldn’t do, but that doesn’t last very long, and if I don’t, then I’m perfectly fine. I still have my disc herniation because I never operated it, but I feel just fine, I’m all sorted. Informant N 10: If I strain myself, I still feel something. But if I live a normal life, I am fine. Informant N 11: To be honest the improvement had been astounding, and I was able to go back to work, and well, the same goes for the housework, because if I have to sweep or clean up under a bed, I feel some discomfort, but I’m thrilled, I am so happy . . . Informant N 16: When I arrived here, I couldn’t walk . . . Now I’m not going to run a marathon, but I’m thrilled just to be able to do things. I wish I had come a year ago. But that leg-pain was awful, and now it’s completely gone, completely. Now I’m back at work and everything, just like it used to be, I’ve recovered my quality of life once again.

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Informant N 22: . . . and about my back, with this (NRT), I have felt great difference, but I still hurt myself if I do things that I know I should not do. Withdrawal from other treatments The treatments most people with LBP are undergoing when referred for NRT are drugs, exercise, massages, electrotherapy, injections and denervation procedures. In some cases, surgery is also being considered. [35–39,44] After undergoing NRT, most people report that their need for other treatments has been either eliminated or significantly reduced [35–39,44]. This leads to high levels of satisfaction, especially among people with chronic LBP, who have been using those treatments for years. Informant N 5: What has worked best in my case has been the staples, and now I feel fine even without taking medication. Informant N 7: I am so happy that my problem has improved so much without me having to go through surgery. Informant N 11: It’s just that I used to take three or four pills in one go for the pain. I had the staples for like five or six months, and after a week . . . not less than a week, I stopped taking anti-inflammatories, because I had fully recovered. Informant N 16: All my doctor suggested was surgery. None of the treatments worked for me, so he told it was the only solution. Until they gave me the staple treatment, and I got cured. Informant N 21: And the truth is that my experience has been wonderful, because since I have had them, I have not had to take any anti-inflammatories, opioid patches or anything of the sort. Not experiencing improvement after NRT NRT fails in 10–15% of cases [35–39,44]. However, when questioned, most people who had initially denied any improvements, report having experienced some degree of pain relief, although short lived. Moreover, they know other people who have improved after NRT. As a result, they do not question the effectiveness of the procedure; they feel that their case is an exception. They state that they would be willing to receive NRT treatment again. Informant N 23: I’ve got a lot of will power and I want to free myself from this situation but the pain won’t let me. Maybe it hasn’t worked in my case because I waited for too long before coming and put up with the pain for too long. Informant N 25: I keep looking out for a chair so I can sit down, while I’m cooking, if I’m peeling something, I will try to sit down. Ironing is something I rarely do, but I am feeling better than I used to. I’m not feeling completely well though, not that well. I feel less pain, but I still can’t do a normal life. Informant N 28: They have treated me with staples three times. When I’ve got staples, I feel better at the beginning, but then it all comes back again . . . I did have periods with less pain and all that, but then it would come back again. Informant N 29: I wonder whether I’m from another planet, nothing works for me, I don’t know, I don’t know, nothing seems to work for me, but at least something should, I don’t know, maybe it’s just that my back is really in bad shape and it doesn’t have a cure, nothing . . . I just don’t know. I know some people who have been cured and are feeling great, really great, that’s why I came here, but everyone’s body is different, and it hasn’t worked on me, it might work later on, I don’t know.

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Risks associated with NRT Risks associated with NRT derive from the presence of the surgical material in the skin, which can cause itching, stinging, reddening or localized infection, especially during the first few days [32–41,44]. In some cases, small long lasting marks where the material was implanted may appear. Participants feel that these inconveniences are negligible compared to the effectiveness of the procedure. Informant N 10: When you sweat, they itch a little. But after a week, they don’t itch or hurt, whether you touch them or not. Informant N 12: When you get dressed, they can get caught on your clothes, sometimes they itch, and you scratch them. Sometimes you realize that in the bathroom with the towel, instead of rubbing it dry, you have to be a bit careful. Informant N 17: They do sting a little, but goodness me . . . I much rather that, than the pain I had, and to be able to move. Informant N 29: I didn’t have any problems with the staples, no infections nor pain, nor any itchiness, I followed the instructions for taking care of them and I was fine. Afterwards you still have the marks, you know, the marks they make, but who cares. Coverage of NRT by the Spanish National Health Service Participants value the fact that NRT is covered by the Spanish National Health Service; this coverage allows all people with LBP to have access to this treatment irrespective of their economic status. Informant N 18: Thank God that such an effective treatment is accessible to everybody. If this were not the case, people with low income could never benefit from it. Participants’ recommendations Participants expect the National Health Service to take charge of the clinical management of their LBP, but also of the psychological consequences of LBP-related disability. They believe that if practitioners had a better understanding of the impact of LBP on their lives, they would be better equipped to care for them. Therefore, they attach great value to qualitative research on their experiences with LBP and its treatment. Informant N 5: I am glad that, for once, health professionals take an interest in finding out how we feel and gathering our opinion on the treatment. Patients consider pain to be the most incapacitating condition. Therefore, they believe that research on effective treatments for pain should be prioritized. They suggest that research on the use of NRT for other painful conditions should also be initiated. Informant N 12: . . . They should look into using NRT to treat pain in other parts of the body, like knees or arms.

Discussion The perceptions of people with LBP in Spain The experience of LBP in Spain appears to be similar to the one in the Anglo-Saxon and Northern European cultural contexts [8–15], despite differences in the relevance of fear-avoidance beliefs and catastrophizing across these settings [16–31]. This further suggests that, although quantitative studies using validated

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methods may be useful for assessing the influence of psychological factors, qualitative methods are necessary to allow patients to express themselves freely over and above the questions included in closed questionnaires. Participants experience LBP as a stigmatizing condition and feel that; practitioners consider them to be annoying individuals who require extra attention; their relatives perceive them as a burden, since they are not able to cope with their housework, and; their colleagues look down on them for taking sick leave frequently. They feel pressured to prove that their pain is real, since they have to endure the skepticism shown by people around them [8–15], and offended by the disbelief displayed by some practitioners, who appear to suspect that they do not want to recover or that they play down any improvements they experience. These perceptions may account for participants’ claim that it is valuable for practitioners to gain a better understanding of the physical and emotional impact of LBP [12]. People with LBP want clinicians to show respect and empathy, and refrain from judging them. This approach appears to protect patients’ dignity and self-esteem. In fact, physicians who display a warm, friendly, and reassuring manner are more effective, probably because they help patients to increase their self-efficacy, which helps them regain independence and participate effectively in their own treatment [58–62]. Results from this study also show that, although people with LBP disregard small or short-lived improvements, when the improvement is clinically relevant they are happy to acknowledge it, look forward to resuming their normal activities and, in fact, do so. This also implies that patients who report no improvements should be trusted. As participants in this study expressed, mistrust from clinicians and the feeling that others perceive them as weak people who constantly complain, increase patients’ suffering, isolation and perception of stigma. The experience of people with LBP while undergoing neuroreflexotherapy One of the cornerstones in the treatment of acute LBP is to reassure patients that they have a good prognosis [1,33,63]. However, this prognosis has turned out to be inaccurate in people with subacute and chronic LBP, in whom treatments have failed and pain persists. Previous research has shown that this is associated with an increase in catastrophizing [31], which may account for the mixed feelings triggered by a new treatment; participants experienced hope, but also incredulity, mistrust, and fear that if, yet again, results failed to meet their expectations, this would further confirm that ‘‘nothing will ever work’’ for them. Nevertheless, when pain improved significantly these negative feelings disappeared quickly. Participants were happy to acknowledge the improvement, and resume normal life. Conversely, participants in whom NRT failed did not question the effectiveness of the technology, but felt that they were ‘‘too seriously impaired’’ to improve. This may be due to the fact that most of them perceived some improvement (although small or transient), or knew other persons suffering from LBP in whom it had worked. It is noteworthy that, in this regard, patients appear to value experiences from other patients they know personally more than the evidence deriving from RCTs or systematic reviews. In fact, in this study no patient inquired about the evidence supporting NRT [32–41,44]. This might be specific to the cultural context in which this study took place, reflect the trust participants feel towards their physicians, or suggest that they assumed that all the failed treatments they had undergone before NRT were also supported by high quality evidence,

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which led them to conclude that ‘‘evidence-based’’ does not necessarily mean ‘‘effective in their specific case’’. Results from this study are consistent with those from previous quantitative studies, which have shown that NRT triggers a clinically relevant improvement in pain and disability, as well as a reduction in the use of drugs and other treatments, a decrease in the duration of sick-leave period, and generates a high level of patient satisfaction, while adverse events are small enough to be considered clinically irrelevant [32–41,44]. This consistency suggests that methods used in those quantitative studies for measuring patients’ overall assessment of their own clinical progression, and changes in pain and disability, reflected patients’ perceptions accurately. According to this study, patients perceive that NRT also improves their QoL. This is consistent with results from quantitative studies in which QoL was measured through the COOP chart [35,64], but not with those in which it was measured with the EuroQol-5D [36]. The low sensitivity of EuroQol-5D to changes in LBP and the lack of validity of its Spanish version may explain this discrepancy [65,66]. Participants in FG4 did not experience any improvements in pain and disability, whereas participants in FG5, who appeared to be the most emotionally frail and to catastrophize even more than participants in FG4, did not report a clinically relevant improvement despite experiencing improvements in pain and disability which were above the standard cut-off points for clinical relevance [46,47]. When questioned, participants in FG4 admitted having improved, but felt that their improvement had been shortlived or had had an impact on their overall situation which did not meet their expectations. Future studies should explore whether self-discrepancies contribute to this. Self-discrepancies are perceived distances between the actual self and self-guides that can exist from two perspectives (i.e. own and other). They are associated with negative mood states, incite self-regulatory behavior, and have a negative impact on the perceived integrity of one’s self [62,67,68]. Actual-ideal and actual-ought discrepancies are hypothesized to be associated with persistent behavior, and actual-feared discrepancies with avoidance behavior [69,70].

Conclusion In conclusion, this study shows that the experience of subacute and chronic LBP in Spain is similar to the one in other cultural contexts; people who suffer from it perceive it as a stigma and feel misunderstood by those who surround them and by some clinicians. They wish to be treated with respect and empathy, by clinicians who refrain from judging them. After having undergone multiple failed treatments, they have mixed feelings towards new treatments, but most are happy to acknowledge significant improvement when they actually experience it. Therefore, people claiming to not have experienced any improvements should be believed. People with LBP feel that Neuroreflexotherapy is effective, is not associated with any relevant risk, and leads to a relevant improvement in pain and disability, which makes it possible for them to withdraw from other treatments and resume a normal life. These results are consistent with previous quantitative and qualitative studies.

Acknowledgements The authors would like to acknowledge the valuable help of Mrs. Magdalena Jaume, for implementing the procedure for selecting the patients, arranging appointments, and acting as observer during the focus groups, and Mrs. Sonia Parra for acting as external auditor, reviewing the process and output of this study. They would also like to thank the patients who kindly

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participated in this study, and offered valuable information on their experiences.

Declaration of interest There are no financial or other relationships between the authors and other third parties which might lead to conflicts of interest. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this article. The authors have no conflicts of interest to report. In accordance with usual practice within the Spanish National Health Service, neither patients, researchers, nor auxiliary personnel received any compensation for participating in this study. No pharmaceutical company, for-profit organization, or not for profit organization linked to a for-profit one, were involved in this study. This study was funded by the Kovacs Foundation (www.kovacs.org), a Spanish not for profit Institution specializing in neck and back pain research, with no links to the health industry. The funding institution did not participate in the design and conduction of the study; data collection; management, analysis and interpretation of the data; preparation, review and approval of the manuscript; or the decision to submit the article for publication. This article was written and edited exclusively by the authors, without any external help from organizations or individuals.

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