Research Review By Dr. Brynne Stainsby©

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Date Posted:

April 2018

Study Title:

National clinical guidelines for non-surgical treatment of patients with recent onset low back pain or lumbar radiculopathy

Authors:

Stochkendahl MJ, Kjaer P, Hartvigsen J et al.

Author's Affiliations:

Department of Sports Science and Clinical Biomechanics, University of Southern Denmark, Denmark; Nordic Institute of Chiropractic and Clinical Biomechanics, University of Southern Denmark, Denmark; The Danish Health Authority, Denmark.

Publication Information:

European Spine Journal 2018; 27(1): 60-75. doi: 10.1007/s00586-017-5099-2.

Background Information:

In 2012, the Danish Health Authority was commissioned to formulate evidence-based, national clinical guidelines related to areas with a high burden of disease, perceived variation in practice or uncertainty about which care was appropriate, including low back pain (LBP) and lumbar radiculopathy (LR) (1).

It is estimated that 15% of Danish people suffer from LBP at a given time, and the majority will experience LBP throughout their lifetime – not dissimilar from other regions around the world (2, 3). With or without radiculopathy, LBP is a leading cause of disability and has a major socioeconomic impact on society, accounting for 10% of visits to a general practitioner and 20% of sick days (2). The majority of those experiencing LBP will experience recurrence (4) and 1-10% will experience LR.

The purpose of this paper was to summarize the two national clinical guidelines (NCG) regarding recommendations based on clinical questions for LBP and LR.

Summary:

  • Of the 20 clinical questions, none could be answered using clinical guidelines or systematic reviews. Sixteen were answered based on RCTs and the remaining four were answered based on consensus.
  • The recommendations from these two guidelines endorse patient enablement through information and education. They recommend advice to remain physically active and supervised exercise in addition to usual care.
  • For pain relief, manual therapy – including joint mobilization and manipulation in addition to usual care was recommended.
  • For patients with LBP, the expert group recommended using pain medication only in the form of paracetamol, NSAIDs and opioids in addition to usual care, only after careful consideration.
  • The routine use of acupuncture was not endorsed for LBP or LR (lumbar radiculopathy).
  • The authors recommended against the use of routine imaging (x-ray or MRI) in patients presenting with recent onset LBP and/or LR.
  • The authors recommended against the use of extraforaminal glucocorticoid injections in addition to usual care in patients with LR.
  • The authors recommended that patients with LR should be referred for surgical consultation within 12 weeks if severe and disabling pain persists despite non-surgical treatment.

Clinical Application & Conclusions:

The authors found a general lack of high quality evidence for non-surgical interventions for the management of recent onset LBP and LR in adults (symptoms less than 12 weeks). These guidelines are thus based on RCTs when possible, or alternatively on expert panel consensus.

The recommendations in this guideline which focus on education, information and exercise in addition to usual care correlate well to other recently published reviews of clinical practice guidelines for the non-surgical/non-invasive management of LBP with or without LR (5, 6). The same can be said for their recommendation for manual therapy (whether mobilization or manipulation) for pain management. Based on the evidence, it is reasonable to incorporate these interventions despite the paucity of evidence regarding specifics of integrating them. This highlights the importance of understanding patient preferences and incorporating clinical experience when providing evidence-based care.

Study Methods:

  • The guidelines were based on systematic reviews and meta-analyses. The authors balanced the evidence of clinical effects against the risk of harms and patient preferences to make recommendations (in accordance with international standards for clinical guidelines, based on the Grades of Recommendations, Assessment, Development, and Evaluation [GRADE] approach) (7, 8).
  • Working groups were appointed from scientific societies, professional organisations and reference groups from the Danish healthcare system and patient organizations provided feedback on the recommendations. Drafts of the clinical guidelines were presented in a public hearing and feedback was considered for the final versions.
  • Two authors independently screened titles and abstracts for inclusion.
  • Each clinical guideline addressed up to 10 clinical questions structured according to the Population, Intervention, Comparison and Outcome (PICO) framework (8).
  • Patient Population: patients above 16 years of age with non-specific LBP (no signs of LR), and patients above 18 years of age with LR. In both guidelines, symptoms must have been present for less than 12 weeks.
  • Interventions and Comparisons: Both guidelines included only non-surgical interventions, and the clinical guideline on LR was restricted to non-pharmacological interventions. It was assumed that all patients would receive information and advice, this basic treatment was considered “usual care” and trials were eligible for inclusion when usual care was provided to both groups and an intervention was added to the intervention group.
  • Outcomes: For most questions related to LBP, back pain intensity and back pain-related activity limitation were determined primary outcomes. For the LR questions, back pain intensity, leg pain intensity, back pain-related activity limitation and neurological deficits were primary outcomes. The working groups defined minimally clinically relevant effects as a difference of 15 mm on a 100 mm VAS, two points on an 11-point NRS and 10 points on a 100-point scale of back pain-related disability.
  • The literature was systematically searched until December 2014 (LR) or March 2016 (LBP) using appropriate search terms for each database. Clinical guidelines, systematic reviews and randomized clinical trials (RCT) published in English, German, Norwegian, Swedish or Danish were included.
  • The lead reviewer screened and retrieved titles and abstracts and potentially eligible papers were collected in full text.
  • The lead reviewer and a member of the working group independently screened full text papers for inclusion. Scientific quality was assessed using the AGREE-II tool for clinical guidelines (9) the AMSTAR tool for systematic reviews (10) and the Cochrane risk of bias tool for RCTs (11).
  • The quality of the evidence was graded from very low to high according to the GRADE definitions (12).
  • Evidence was summarized into evidence tables and forest plots were constructed when meta-analyses were possible. Based on the evidence, strong or weak recommendations were made for or against an intervention. In the case where no evidence was available from RCTs, a good practice recommendation was made based on the consensus of the working group.

Study Strengths / Weaknesses:

Strengths:
  • Clearly defined research questions were addressed with a thorough and systematic search.
  • Independent screening of full texts.
  • Only those trials assessed as being of high quality were included.
  • Assessment of risk of bias was performed with a validated set of criteria.
  • In addition to methodological quality, clinical relevance was also assessed.
  • Two authors independently extracted the data from the included articles.
  • Working groups were composed of clinicians and researchers, in order to address both methodological quality and clinical relevance.
  • The guidelines underwent thorough peer-review and revision.
Weaknesses:
  • The primary limitation of this study relates more to the quality of the body of evidence than the methodology of the review itself.
  • Given the paucity of high quality evidence, most recommendations were based on consensus of the working group.

Additional References:

  1. Danish Health Authority. Mandate for Development of National Clinical Guidelines [In Danish]. 4-1013-10/1/SBRO. Denmark: Danish Health and Medicines Authority, 2012.
  2. Flachs EM, Eriksen L, Koch MB et al. The burden of disease in Denmark – Diseases. National Institute of Public Health, University of Southern Denmark. Copenhagen: Danish Health Authority, 2015.
  3. Danish Health Authority. Health of the Danish people – The national health profile 2013. Danish Health Authority, Copenhagen, 2014.
  4. Dunn KM, Hestbaek L, Cassidy JD. Low back pain across the life course. Best Pract Res Clin Rheumatol 2013; 27(5): 591–600.
  5. Wong JJ, Cote P, Sutton DA et al. Clinical practice guidelines for the noninvasive management of low back pain: a systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Eur J Pain 2016; 21(2): 201–216.
  6. National Institute for Health Care Excellence. Low back pain and sciatica: management of non-specific low back pain and sciatica. National Institute for Health Care Excellence, London 2016.
  7. Qaseem A, Forland F, Macbeth F et al. Guidelines International Network: toward international standards for clinical practice guidelines. Ann Intern Med 2012; 156(7): 525–531.
  8. Guyatt GH, Oxman AD, Kunz R et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol 2011; 64(4): 395–400.
  9. Brouwers MC, Kho ME, Browman GP et al. AGREE II: advancing guideline development, reporting and evaluation in health care. J Clin Epidemiol 2010; 63(12): 1308–1311.
  10. Shea BJ, Grimshaw JM, Wells GA et al (2007) Development of AMSTAR: a measurement tool to assess the methodological quality of systematic reviews. BMC Med Res Methodol 2007; 7:10.
  11. Furlan AD, Pennick V, Bombardier C et al. 2009 updated method guidelines for systematic reviews in the Cochrane Back Review Group. Spine 2009; 34(18): 1929–1941.
  12. Balshem H, Helfand M, Schunemann HJ et al. GRADE guidelines: 3. Rating the quality 
of evidence. J Clin Epidemiol 2011; 64(4): 401–406.