Clinical Practice Guideline
Non-Specific Low Back Pain
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Background: For many years, low back pain has been both the leading cause of days lost from work and the leading indication for medical rehabilitation. The goal of the German Disease Management Guideline (NDMG) on non-specific low back pain is to improve the treatment of patients with this condition.
Methods: The current update of the NDMG on non-specific low back pain is based on articles retrieved by a systematic search of the literature for systematic reviews. Its recommendations for diagnosis and treatment were developed by a collaborative effort of 29 scientific medical societies and organizations and approved in a formal consensus process.
Results: If the history and physical examination do not arouse any suspicion of a dangerous underlying cause, no further diagnostic evaluation is indicated for the time being. Passive, reactive measures should be taken only in combination with activating measures, or not at all. When drugs are used for symptomatic treatment, patients should be treated with the most suitable drug in the lowest possible dose and for as short a time as possible.
Conclusion: A physician should be in charge of the overall care process. The patient should be kept well informed over the entire course of his or her illness and should be encouraged to adopt a healthful lifestyle, including regular physical exercise.
For many years, low back pain has been both the leading cause of days lost from work and the leading indication for medical rehabilitation (1, 2). Musculoskeletal diseases have been second only to mental disorders in recent years as a cause of early retirement due to loss of the ability to work (3). In 2010, 26% of all adults participating in the mandatory nationwide health insurance system in Germany sought medical help at least once because of low back pain (4). The new update of the German Disease management Guideline (NDMG) on non-specific low back pain (5) contains many new elements. Among other things, psychosocial and workplace-related factors are given more emphasis, multiple imaging procedures are discouraged, and early multidisciplinary assessment is recommended. Moreover, both the guideline’s positive recommendations, such as those for less intensive diagnostic evaluation and for exercise rather than bed rest, and its negative recommendations, such as the recommendation against passive measures, are now supported by high-level evidence and confirmed by the guideline group.
The following instruments were used in the creation of the NDMG:
- The concepts of the Guidelines International Network (G-I-N),
- the guideline criteria of the German Medical Association (Bundesärztekammer, BÄK) and the National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) (6),
- the guideline regulations of the Association of the Scientific Medical Societies in Germany (Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften, AWMF) (e1), and
- the German Guideline Evaluation Instrument (Deutsches Leitlinienbewertungsinstrument, DELBI) (e2).
The essentials of the guideline-creating procedure are described in the methods report (e3), and specific details are described in the guideline report (e4). The current version of the NDMG on non-specific back pain was developed from March 2015 to March 2017 by a multidisciplinary guideline group (eBox 1). It was then organized by the German Association for Quality Assurance in Medicine (Ärztliches Zentrum für Qualität in der Medizin, ÄZQ). All of the participants’ conflicts of interest have been documented and made public, as stipulated by the AWMF (e4).
For this update, a systematic search was carried out in Medline (via PubMed) and the Cochrane database for aggregated evidence regarding non-specific low back pain (eTable 1). In a two-step procedure, the retrieved articles were examined and their key questions and recommendations were classified, extracted, and evaluated (eFigure 1) (e4). On some issues, such as the use of opioids to treat acute, non-specific back pain, supplementary searches for primary studies were carried out. Moreover, the S3 guideline on the long-term use of opioids to treat non-cancer pain (LONTS) (7) was used as a reference guideline.
Recommendation grades and consensus process
Recommendation grades were assigned in consideration of the following:
- the strength of the underlying evidence
- ethical commitments
- the clinical relevance of the effect strengths that were documented in the studies
- the applicability of the study findings to the target patient group
- patient preferences
- and the practicality of implementation in routine clinical practice.
Two upward arrows (↑↑) indicate a strong recommendation, a single upward arrow (↑) indicates a weak recommendation, and a horizontal double arrow (↔) indicates an open recommendation. The recommendations, algorithms, and information for patients were agreed upon in a formalized, written voting procedure (Delphi process) or in a consensus conference (nominal group process). The draft guideline was made accessible for public comment in September 2016 (www.versorgungsleitlinien.de). Potential consequences of the comments that were received were voted upon in a written Delphi process (e4).
If the initial history and physical examination of a patient with low back pain do not yield any sign of a dangerous course of the disease or other serious conditions, no further diagnostic steps should be undertaken for the time being (↑↑, expert consensus). Restricting the diagnostic evaluation spares the patient an unnecessary burden while avoiding unnecessary costs for the health-care system (e5). Intensive diagnostic evaluation that is not justified by clinical findings will only exceptionally result in a relevant, specific diagnosis and may well promote the patient’s fixation on his or her condition and the chronification of pain (e6–e8). The Figure is a depiction of the diagnostic course of a patient with acute low back pain or a new episode of recurrent back pain, starting from the initial contact with a physician. If any somatic warning signs (“red flags”) are present (eBox 2), then further imaging or laboratory tests and/or referral to a specialist should ensue, depending on the particular diagnosis that is suspected and its degree of urgency (↑↑, expert consensus).
Psychosocial and workplace-related risk factors (eBox 2) should be considered from the beginning (↑↑, expert consensus). After four weeks of persistent pain with an inadequate response to treatment that has been provided in accordance with the guideline (eFigure 2), the coordinating physician should assess psychosocial risk factors (“yellow flags”) with a standardized screening instrument (e.g., the STarT Back Tool or the Örebro Short Questionnaire) (↑, expert consensus) and may also assess workplace-related factors with a standardized screening instrument (↔, expert consensus). Patient information and related questionnaires are freely accessible via the German-language website www.kreuzschmerz.versorgungsleitlinien.de.
Patients with acute or recurrent low back pain in whom the history and physical examination yield no evidence of a dangerous course of the disease or other serious condition should not undergo any imaging (↓↓, [8, 9]). A systematic review of randomized and controlled trials (RCTs) revealed that, among patients with acute or subacute low back pain who have no clinical evidence of a serious condition, the intensity of pain at three months or at 6–12 months was no different in those who underwent imaging immediately than in those who had no imaging at all (standardized mean difference [SMD] at 3 months 0.11, 95% confidence interval [−0.29; 0.50]; corresponding figures at 6 months, −0.04 [−0.15; 0.07]), and at 12 months 0.01; [−0.17; 0.19]); the two groups of patients received the same treatment (8). These data were confirmed by a prospective cohort study involving 5239 patients over age 65 with acute low back pain: at one year, there was no difference in functional ability between patients who underwent imaging at an early or late date (i.e., less vs. more than 6 weeks after diagnosis). The SMD and confidence interval figures were, for plain x-rays, −0.10 [−0.71; 0.5]; for magnetic resonance imaging (MRI) and computed tomography (CT), −0.51; [−1.62; 0.60]) (9). Moreover, imaging can lead to unnecessary treatment and promote chronification (10). Patient information leaflets were developed as an aid to physician-patient communication on this topic.
Most patients experience appreciable improvement within 6 weeks (11). For patients whose low back pain continues to limit their physical activity or has worsened despite treatment in accordance with the guideline (eFigure 2), the indication for diagnostic imaging should be reassessed in 4 to 6 weeks (↑↑, expert consensus based on [10, 12]). Early reassessment in 2–4 weeks may be necessary if a currently employed patient has been unable to work for a considerable period of time, or if a diagnostic evaluation is required before the initiation of multimodal treatment. The authors of the guideline consider one-time diagnostic imaging to be justified as part of such an assessment, alongside the history and physical examination. Nevertheless, imaging that lacks any potential therapeutic relevance should be avoided. After 4–6 weeks of pain, physicians should place greater emphasis on the search for a specific somatic cause than at the patient’s initial presentation. Even in patients with persistent pain, however, the physician should first consider whether the symptoms and course might not be accounted for by other risk factors or by the individual history. Current evidence does not support routine imaging (e.g., MRI) for chronic, non-specific low back pain (12).
An analysis of claims data by WIdO (which is the scientific department of AOK, a German health-insurance carrier) revealed that 26% of patients with low back pain underwent two instances of diagnostic imaging of the lumbar spine within 5 years, and 27% underwent three or more (4). Patients with unchanged symptoms should not undergo repeated imaging (↓↓, expert consensus), as there is no reason to expect any relevant structural changes calling for a change in the treatment strategy. If the symptoms change, however, the indications for imaging may need to be reassessed.
Patients whose activities in everyday life are still restricted and who still have inadequate relief of pain despite 12 weeks of treatment in accordance with the guideline, as well as patients with an exacerbation of chronic non-specific low back pain, should undergo multidisciplinary assessment (↑↑, expert consensus). Patients at high risk of chronification should undergo such an assessment after 6 weeks of persistent pain (eFigure 2). In the assessment, the patient’s symptoms are evaluated as comprehensively and holistically as possible and the findings are discussed in a multidisciplinary case conference, where plans are made for further diagnostic evaluation and treatment.
In the outpatient setting, the principles of multidisciplinary assessment are best met by combining the diagnostic expertise of the physician, the physical therapist, and the psychologist. Broad implementation is generally difficult in ambulatory care but is feasible in the German health care system with the aid of an “integrated care contract” (IV-Vertrag; IV = integrierte Versorgung). Such assessments are regularly performed in multidisciplinary pain centers, which are entitled to obtain reimbursement for them, but usually only in a later phase of the course of the disease (13).
The management of low back pain
A physician should be responsible the overall care process (Figure and eFigure 2) (↑↑, expert consensus). Over the course of the disease, the physician should continually explain the condition and the treatment to the patient and should encourage the pursuit of a healthful lifestyle, including regular physical exercise (↑↑, [e9–e13]). Recommendations for special situations are summarized in Box 1. The diagnostic and therapeutic process for patients with persistent low back pain is presented in eFigure 2.
Patients should be instructed to continue their usual physical activities as much as possible (↑↑, ). Systematic reviews of RCTs have shown that bed rest for patients with acute non-specific low back pain either has no effect or actually delays recovery and the resumption of everyday activities, leading to longer periods of medically excused absence from work (14, 15). Bed rest should not be a part of the treatment of non-specific low back pain, and patients should be advised against it (↓↓, [14, 15]).
Exercise therapy combined with educative measures based on behavioral-therapeutic principles should be used in the primary treatment of chronic non-specific low back pain (↑↑, [16, e14–e38]). It yields more effective pain reduction and better functional ability than can be achieved with general medical care and passive treatment measures (16, e14–e34). Programs for strengthening and stabilizing the musculature seem to relieve low back pain better than programs with a cardiopulmonary orientation (e35, e36). Reviews of RCTs have shown that exercise programs based on a behavior-therapeutic approach improve physical functional ability and speed up the return to work (e22, e37). Current evidence does not show which specific type of exercise therapy is best for pain relief and improved functional ability (e14–e34). The choice of exercise therapy is, therefore, based mainly on the patient’s preference, everyday life circumstances, and physical fitness and the availability of a qualified therapist to carry it out (e39).
Weaker recommendations are given for rehabilitative sports and functional training (↑, expert consensus) and progressive muscle relaxation (↑, [e40]). Self-administered heat therapy (↔, [15, e41–e43]), manual therapies such as manipulation and mobilization (↔, [e44–e47]), massage (↔, [17, e34, e48, e49]), ergotherapy (↔, [e50]), “back school” (↔, [17, e51–e54]), and acupuncture (↔, [e28, e55–e57]) can be used to treat chronic low back pain as part of an overall concept in combination with activating therapeutic measures.
Strongly negative recommendations are given with regard to interventions for which there is little or no evidence of benefit, even if there is no evidence of harm either. This is done so as not to imply that these methods are an acceptable alternative to maintaining physical activity; a passive approach to treatment should not be promoted. The authors of the guideline, considering this to be a relevant potential harm, have altered the recommendation strengths accordingly. These interventions, while discouraged, may still be used in individual cases, in combination with physical exercise, as long as there is no evidence that they cause harm. Negative recommendations are given for interference-current therapy (e58–e62), kinesiotaping (e63, e64), short-wave diathermy (e65–e68), laser therapy (17, e69), magnetic field therapy (e70), medical aids (e71–e74), percutaneous electrical nerve stimulation (PENS) (17, e75), traction devices (17, e76), cryotherapy (e41), transcutaneous electrical nerve stimulation (TENS), and therapeutic ultrasound (e77, e78).
The treatment of non-specific low back pain with drugs is purely symptomatic. In the acute phase, drugs are used to support non-pharmacologic measures, so that the patient can return to his or her usual activities as soon as possible. The treatment of chronic low back pain with drugs is indicated if the physician considers it potentially helpful for the implementation of activating measures, or else when, despite the appropriate performance of these measures, the patient still has an intolerable functional impairment due to pain.
Overall, there is moderate evidence with a low-to-intermediate effect size showing that treatment with drugs relieves acute and chronic non-specific low back pain. Particularly long-term treatment carries relevant risks including major adverse effects. It follows that the physician must carefully weigh the risks and benefits of pharmacotherapy when starting pharmacotherapy (Box 2).
Nonsteroidal anti-inflammatory drugs (NSAID) are the pain-relieving drugs most likely recommended. Multiple reviews have documented the short-term analgesic effect and the functional benefit of oral NSAID, compared to placebo, in patients with acute and chronic non-specific low back pain, with a median difference of −5.96 points [−10.96; −0.96] at 16 weeks on a Visual Analog Scale ranging from 0 to 100 (15, 18–21). To minimize side effects NSAIDs should be given in the lowest effective dose and for the shortest possible time (↑). Considering the contraindications, COX-2-inhibitors can be used if NSAIDs are contraindicated or poorly tolerated (off-label-use) (↔, [18–20]).
In individual cases, metamizole can be considered as an treatment option if non-opiod analgesics are contraindicated or poorly tolerated. (↔, expert consensus). The systematic literature search yielded no reviews documenting its efficacy against non-specific low back pain. The Medicines Committee of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ) recommends its use only for the approved indications (severe pain for which other treatments are not indicated) and states that the patient must be adequately informed about its side effects, particularly the manifestations of agranulocytosis, which include fever, sore throat, and lesions of the oral mucosa. Monitoring of the complete blood count is recommended whenever agranulocytosis is suspected, as well as for all patients taking the drug over the long term (22).
In the light of new evidence, paracetamol ( = acetaminophen) should no longer be used (↓, ). In comparison to placebo, the use of this drug did not lead to any improvement in pain (weighted mean difference [WMD] 1.4 [−1.3; 4.1]) or functional ability (WMD −1.9 [−4.8; 1.0]) in patients with either acute or chronic non-specific low back pain. Nor should flupirtine be used to treat non-specific low back pain (↓↓, [24–32]): its inadequately documented benefit is outweighed by its risks—mainly hepatotoxicity, ranging from elevated liver function parameters to organ failure, and potential dependence (27–29) (cf. the risk assessment of the European Medicines Agency [EMA] ).
Opioid drugs can be a treatment option for acute non-specific low back pain if non-opioid analgesics are contraindicated or have been found to be ineffective in the individual patient (↔, [e82–e86]). The indication for opioid drugs should be regularly reassessed at intervals of no longer than 4 weeks (↑↑, ). They can be used to treat chronic non-specific low back pain for 4 to 12 weeks initially (↔, [19, 34–36]). If this brief period of treatment brings about a relevant improvement in the patient’s pain and/or subjective physical impairment, while causing only minor or no side effects, then opioid drugs can also be a long-term therapeutic option (↔, ). In the review articles that were identified for the creation of this guideline, the administration of opioid drugs (weak and strong, oral and transdermal) for a brief or intermediate period of time (4 to 26 weeks) significantly reduced pain (SMD: −0.43 [−0.52; −0.33]) and mildly improved physical functional ability (SMD: −0.26 [−0.37; −0.15]) compared to placebo (19, 34–36). Open long-term observations from the late observational phase of RCTs have revealed long-term analgesic efficacy in approximately 25% of the patients initially included in the trials (37). The most important points to be considered with respect to opioid therapy are summarized in the Table.
Non-specific low back pain should not be treated with percutaneous procedures (↓↓, [e34, e87–e94]) or with surgery (↓↓, [e95–e103]). Nor should intravenously, intramuscularly, or subcutaneously administered analgesic drugs, local anesthetics, glucocorticoids, or mixed infusions be used (↓↓, [e104–e112]).
Multimodal treatment programs
Patients with subacute and chronic non-specific low back pain should be treated in multimodal programs if less intensive evidence-based treatments have yielded an insufficient benefit (↑↑, [17, 38, 39]). Trials have shown the superiority of multimodal programs over traditional treatments, waiting lists, or less intensive forms of treatment (17, 38, 39). According to the most recent review, including data from a total of 6858 study participants, multimodal treatment was better than traditional treatment at lowering pain intensity (SMD: −0.21 [−0.37; −0.04]) and increasing physical functional ability (SMD: −0.23 [−0.40; −0.06]) at 12 months in patients with chronic, non-specific low back pain (38). The evidence in the underlying trials is of low to moderate quality, and some of the measured effects are weak. The heterogeneity of the findings can be attributed, in part, to wide variation in the content of the multimodal programs (39). In practice, such programs are offered by pain clinics and rehabilitation clinics (eTable 2).
We thank all authors and participants in the NDMG on non-specific low back pain: Prof. Dr. Heike Rittner, Prof. Dr. Monika Hasenbring, Dr. Tina Wessels, Patrick Heldmann, Prof. Dr. Annette Becker, Dr. Bernhard Arnold, Dr. Erika Schulte, Prof. Dr. Elke Ochsmann, PD Dr. Stephan Weiler, Prof. Dr. Werner Siegmund, Prof. Dr. Elisabeth Märker-Hermann, Prof. Dr. Martin Rudwaleit, Dr. Hermann Locher, Prof. Dr. Kirsten Schmieder, Prof. Dr. Uwe Max Mauer, Prof. Dr. Dr. Thomas R. Tölle, Prof. Dr. Till Sprenger, Dr. Wilfried Schupp, Prof. Dr. Thomas Mokrusch, Dr. Fritjof Bock, Dr. Andreas Korge, Dr. Andreas Winkelmann, Dr. Max Emanuel Liebl, PD Dr. Dipl.-Psych. Regine Klinger, Prof. Dr. Dipl.-Psych. Michael Hüppe, Dr. Dipl.-Psych. Anke Diezemann, Prof. Dr. Volker Köllner, Dr. Beate Gruner, Dr. Silke Brüggemann, Prof. Dr. Thomas Blattert, Dr. Matti Scholz, Prof. Dr. Karl-Friedrich Kreitner, Prof. Dr. Marc Regier, Prof. Dr. Hans-Raimund Casser, Ludwig Hammel, Manfred Stemmer, Prof. Dr. Tobias Schulte, Patience Higman, Heike Fuhr, Eckhardt Böhle, Reina Tholen, Dr. Dagmar Lühmann, Prof. Dr. Jost Langhorst, Dr. Petra Klose, Dr. Monika Nothacker, Dr. Christine Kanowski, Corinna Schaefer, Dr. Dr. Christoph Menzel, Peggy Prien, Isabell Vader.
Conflict of interest statement
Prof. Chenot has served as a paid consultant for WIdO, for the Bertelsmann Foundation, and for the Institute for Applied Health Care Research (Institut für angewandte Gesundheitsforschung, InGef).
Prof. Greitemann has served as a paid consultant for Bauerfeind AG. He has received author’s honoraria for works published by Springer and Thieme.
He has received research funding from DRV Westfalen (a pension insurance company).
Prof. Kladny has received lecture honoraria from Bauerfeind.
Prof. Petzke has served as a paid consultant for Janssen-Cilag.
He is the director of a multimodal pain treatment facility.
Prof. Pfingsten has received lecture honoraria from Abbvie, Gruenenthal, and Pfizer.
Dr. Schorr states that she has no conflict of interest.
Manuscript submitted on 28 July 2017, revised version accepted on
26 October 2017.
Translated from the original German by Ethan Taub, M.D.
Dr. rer. nat. Susanne Schorr
Ärztliches Zentrum für Qualität in der Medizin (ÄZQ)
Strasse des 17. Juni 106–108
10623 Berlin, Germany
For eReferences please refer to:
eFigure, eTables, eBoxes:
Opioids compared to placebo or other treatments for chronic low-back pain. Cochrane Database Syst Rev 2013; 8: CD004959 CrossRef
Section Family Medicine, Institute for Community Medicine, University Hospital of Greifswald: Prof. Dr. med. Chenot
Klinik Münsterland, DRV Westfalen: Prof. Dr. med. Greitemann
Department of Orthopedics, Fachklinik Herzogenaurach: Prof. Dr. med. Kladny
ain Clinic, Center for Anesthesiology, Emergency and Intensive Care Medicine, University Hospital Göttingen: Prof. Dr. med. Petzke, Prof. Dr. Dipl.-Psych. Pfingsten
German Agency for Quality in Medicine (AQuMed/ÄZQ), Berlin: Dr. rer. nat. Schorr
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