April 2023

Consensus on a standardized treatment pathway algorithm for lumbar spinal stenosis: an international Delphi study

Comer C, Ammendolia C, Battie M, et al.

Leeds Community Healthcare NHS Trust, Leeds, UK; Faculty of Medicine, University of Leeds, Leeds, United Kingdom; Faculty of Medicine, University of Toronto and Mount Sinai Hospital, Toronto, Ontario, Canada; Faculty of Health Sciences and Western’s Bone and Joint Institute, Western University, London, Ontario

BMC Musculoskeletal Disorders 2022; 23: 550.

Lumbar spinal stenosis (LSS) is a common condition affecting older adults, which is treated with a variety of non-surgical and surgical interventions (1). Despite up to 35% of patients having poor satisfaction with surgical outcomes at one-year follow-up and the lack of sustained benefits of surgery at 2-4 years’ follow-up, there have been an increasing number of LSS surgeries performed (2, 3-5). Aside from urgent cases involving cauda equina symptoms or significant neurological deficits, surgery is generally regarded as an elective procedure for patients who fail to obtain satisfactory outcomes with non-surgical, conservative care (2).

Non-surgical treatment options are frequently used in the management of LSS, but there is limited research to support their use (6). In addition, there is uncertainty regarding which patients are likely to respond to specific treatments, posing a challenge to both patients and clinicians (7). Therefore, this study attempted to reach international expert consensus on an acceptable treatment algorithm to guide clinical practice for those seeing LSS patients.

During the first phase, 57 treatments under 11 categories and 8 investigation procedures were compiled from existing systematic review papers on lumbar spinal stenosis (LSS). Among 323 experts from 6 continents and representing 7 professions, consensus was achieved for the inclusion of two treatment categories for all three LSS phenotypes, which were: 1) advice and education, and 2) exercise. In addition, multimodal care was included for phenotypes A and B, and manual therapy was included for phenotype C (phenotypes are outlined in Study Methods below). Two entire treatment categories, which were complementary therapies and physical modalities, received endorsement from fewer than 30% of respondents for all three phenotypes, leading to their exclusion following the first round.

In phase 2, 159 respondents completed the survey, and advice and education were suggested to always be provided for all three phenotypes. Consensus was achieved for manual therapy, medications and spinal injections to be part of a stepped care approach for all three phenotypes and for walking aids to be included in a stepped care approach for phenotype B. For treatment options consisting of exercise, psychologically informed care, walking aids for phenotypes A and C, and surgery, consensus was not achieved regarding when these treatments should be provided. Furthermore, key indicators for considering investigations for spinal injection and surgery were determined, each based on average scores of > 7/10 on a 0-10 scale of agreement.

In the final round completed by 397 experts, 79% responded that they believe there is currently a large degree of unwarranted variation in care for people with LSS and 88% state they believe that the development and implementation of this treatment algorithm is likely to reduce unwarranted care for this population. 86% of respondents rated that they agree with the algorithm and there was consensus that the algorithm would be useful for clinicians in different clinical settings. Furthermore, there was consensus that the algorithm would be useful to healthcare researchers and healthcare providers, but not to healthcare/medical insurers. Although there was overall consensus, mixed views were expressed about how a standardized treatment algorithm fits in clinical practice alongside clinical reasoning based on experience and expertise. In addition, issues were raised regarding implementation, specifically focusing on the resources required.

The proposed algorithm presented in this paper assists in guiding clinical care and combines both stratified and stepped care approaches. The pathway advocates for immediate imaging/surgical opinion for those with specific clinical indications, while for others, a stepped care approach or self-directed care plan is suggested, taking into consideration different lumbar stenosis phenotypes. Patients following a stepped-care pathway involves tailored multimodal rehabilitation involving exercise and education in step one, with more complex multidisciplinary care or imaging/investigation and surgery considered if required. Treatments can be followed in a stepwise fashion or entered at any point along the pathway depending on clinical need, response to previous treatment, and/or on suspicion of serious disease.

Stratified and stepped care are different approaches which can help direct more intensive treatments to patients who need them and will benefit from them, while avoiding overtreatment or exposure to risk for those who require fewer intensive interventions or no treatment. Stratified care assumes patients who will benefit from more intensive or invasive treatment without the risk of harm or overtreatment can be identified early. Stepped care, on the other hand, assumes a substantial number of patients will benefit from less intensive and invasive treatments first and will not be harmed by a delay in accessing more intensive treatments. Combining a stepped and stratified approach into the management of lumbar stenosis and integrating support for self-management may be the most promising option for the current delivery of care with the minimum burden or risk to patients (8).

This modified Delphi approach combined expertise and opinions of international spine researchers and clinicians, providing validity for the proposed algorithm as a framework to guide clinical care. While the algorithm aligns with and expands upon recommended treatment in current guidelines, some decisions in the pathways warrant further discussion. For example, although advice and education are important and recommended in numerous guidelines, there is no agreed source of clear and comprehensive advice and education for patients with stenosis. In addition, exercise treatments are recommended, but there is insufficient evidence to inform the most effective combination or determine the optimal type or dosage.

Although medication was not excluded at any point in the consensus process, the steering committee agreed that any specific medications have insufficient evidence to advocate for them. Spinal injections were excluded from the algorithm for neurogenic claudication phenotypes based on recent evidence-based guidance and internal consensus (9) and was only included for patients with radicular pain symptoms, which is in-line with other recommendations (10).

For surgical treatment, the most popular sequencing options selected by study participants were either as part of stepped care or in presence of specific clinical indications. Patients with red flag indicators are suggested to go straight to imaging and surgical opinion. However, surgery failed to reach the 70% consensus regarding where to place it within the stepped care pathway for patients without surgical indications.

In conclusion, advice, education, and exercise are advocated for in order to aid in self-management for LSS. The stepped care approach starts with individually tailored rehabilitation and offers multidisciplinary care combining physical and psychological approaches, with surgery being offered only if indicated. The pathway suggests various entrance and exit points based on the patient’s response to previous treatment, symptom severity, functional limitations and suspicion of serious, underlying disease. This algorithm is a helpful guide to assist in clinical decision making until more robust evidence is available.

This was a three-phase Delphi method study. A steering committee of international experts consisting of surgeons, physicians, and manual therapy/allied health professions across six countries were selected, in addition to patient and public representatives with lumbar stenosis.

Phase 1:
The first phase consisted of meetings with the study steering committee and patient and public representatives to compile a preliminary list of potential treatments that were used to develop a questionnaire for the first online survey. This phase focused on establishing an agreed upon set of treatment options that were matched to the description of three lumbar stenosis patient phenotypes.

Clinicians and researchers that were identified as experts took part in the survey after an invitation was sent via email. Musculoskeletal healthcare providers including physiotherapists, chiropractors, osteopaths, spinal surgeons and physicians were also invited.

Phase 2:
The second phase of the study focused on sequencing treatments for the three different phenotypes, refining the pathways for each one and incorporating them into an algorithm. Participants were asked to rank treatments from round 1 within a treatment pathway for each phenotype with response options ranging from ‘Always’ to ‘Never’. Evidence was provided to participants as the aim was to facilitate the incorporation of current evidence into the development of treatment pathways. The resulting pathways were combined into a single algorithm which was clinically appropriate, outlining treatment steps for each phenotype.

Phase 3:
This phase aimed to develop consensus on the proposed algorithm and elicit views about how useful the algorithm might be for different stakeholder groups.

After each round, data was compiled and analyzed to generate a list of retained treatment items and pathway sequencing options. Decisions were based on a pre-determined consensus threshold of more than 70%. If more than 70% endorsed the item and fewer than 30% rejected it, the item was retained. Conversely, if more than 70% rejected the item or fewer than 30% endorsed an item, it was excluded. All other scoring patterns were taken to indicate non-consensus.