Research Review By Dr. Michael Haneline©

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Date Posted:

September 2020

Study Title:

Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial

Authors:

Konstantinou K, Lewis M, Dunn K, et al.

Author's Affiliations:

Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care; Keele Clinical Trials Unit, Keele University, United Kingdom; Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, United Kingdom

Publication Information:

Lancet Rheumatology 2020 Jun 25; 2(7): e401-e411.

Background Information:

The term sciatica refers to pain that radiates from the low back to the posterior leg and is often associated with sensory and motor deficits. Sometimes the pain only affects the leg, sparing the low back. The pain is most commonly caused by a prolapsed lumbar disc compressing one of the lumbar spinal nerve roots.

Sciatica patients are often managed by primary care physicians using what can be termed ‘usual care’. This type of care involves a stepped-care approach that initially involves conservative interventions like advice, medications and physiotherapy (or chiropractic care). If patients do not improve within a reasonable time period, they are subsequently referred for imaging, assessment by a specialist and possibly more invasive treatments, like injections and surgery. This stepped approach is thought to be advantageous because patients with prolonged symptoms have been shown to experience worse outcomes (1). Nonetheless, there is currently a great deal of variation in clinical practice as to which patients need additional care and at what point referral should be made.

A stratified care approach has been developed for patients with non-specific low back pain, which has been shown to be both clinically and cost effective. The stratified care approach involves the use of a stratification tool that identifies patients’ risk of developing disability due to persistent back pain and then matches them to appropriate treatments. However, it is not known whether this approach would be effective for patients presenting with sciatica.

These authors had previously developed a stratified care algorithm to be used with patients presenting with sciatica in primary care. This algorithm uses the STarT Back tool and combines information about the risk of persistent disability as being low, medium, or high with clinical criteria (e.g. current leg pain, pain below the knee, interference with work or home activities, and objective sensory deficits) associated with referral to spinal specialist services. This information is used to allocate patients into one of three groups that are each matched to a care pathway, as follows:
  • Group 1: Patients at low risk of poor outcome, regardless of their clinical characteristics, are offered up to two sessions with a physiotherapist for brief support with self-management.
  • Group 2: Patients at medium risk of poor outcome, including the remainder of patients who do not fit in Group 1 or 3, are offered up to six sessions of physiotherapy.
  • Group 3: Patients at medium risk of poor outcome who have all four clinical characteristics, along with patients at high risk of poor outcome with any three of the clinical characteristics, are offered a matched care pathway that involves fast-track to MRI and referral to a spinal specialist.
The objectives of this study were to investigate whether the stratified care model leads to faster resolution of sciatica symptoms as compared with non-stratified usual care, and whether this approach is cost-effective.

Pertinent Results:

Recruiting efforts resulted in 476 patients being randomized, with 238 assigned to stratified care and 238 assigned to the usual care arm.

The response rate to text messages for the primary outcome was 88% in the stratified care arm and 90% in the usual care arm. The follow-up rate for the questionnaire at 4 months was 81% in the stratified care arm and 84% in the usual care arm, and at 12 months was 74% in the stratified care arm and 76% in the usual care arm.

The median time to symptom resolution (the primary outcome) was 10 weeks in the stratified care arm and 12 weeks in the usual care arm, although this difference was not statistically significant. However, the group of patients that were diagnosed with spinal stenosis appeared to experience a median 6 weeks faster symptom resolution with stratified care. The median number of 2 physiotherapy treatment sessions was about the same for participants in both arms.

There were also no significant differences between treatment arms with regard to secondary outcomes. Most participants improved similarly during follow-up on most outcomes. On the other hand, about 25% of all patients did not report symptom resolution (i.e., completely recovered or much better). Responses to the 12-month questionnaire showed 89 patients reported being no better or being worse (43 in the stratified care arm and 46 in the usual care arm).

No adverse events were reported in either trial arm and most participants were satisfied with the care they received and the results of their care.

A cost-utility analysis showed that stratified care was slightly less effective and actually more costly than usual care.

Clinical Application & Conclusions:

The researchers in this study attempted to determine whether a stratified care model would lead to faster resolution of sciatica symptoms as compared to usual care, but the reported difference between care arms was not statistically significant. Therefore, there is no apparent advantage to the use of a stratified care model in the management of sciatica patients, especially when one considers that stratified care was shown to be slightly less effective and also more costly than usual care.

In contrast, a similar stratified care model, which uses a stratification tool to identify patients’ risk of disability due to persistent back pain and then matches them to appropriate treatments, has previously been shown to be both clinically- and cost-effective for patients with non-specific low back pain (2, 3).

EDITOR’S NOTE: The reason for the discrepancy just mentioned is not clear at this time. Or, is it clear? It is reasonable that, in general, sciatica is a more severe condition compared to an average case of low back pain, which may explain some of this difference. In practice, as you’re aware, those with true sciatica often have higher (initial) pain and disability levels, in addition to an underlying anatomical issue (most often a lumbar disc issue). With that in mind, the severity of their initial symptomatology does not always dictate the rate at which they respond to care (that is, some with severe pain respond quickly, while some with minimal symptoms do not). This complicates things for us as clinicians, but also makes researching this condition more complex. As always, a reasonable approach is to assess each patient individually and tailor your treatment approach accordingly. If the sciatica is the result of a disc problem, find symptom-modifying unloading patterns, employ pain relief measures (including spinal mobilization or manipulation, if tolerable and not contraindicated) and keep them moving!

Study Methods:

This was a pragmatic, randomized controlled trial. Pragmatic means that the clinicians utilized real-world practice methods instead of rigid treatment protocols and strict inclusion/exclusion criteria like what would be utilized in an efficacy study.

Patients were recruited from general practices in three centers in the UK which included the five community physiotherapy practices where patients in Groups 1 and 2 received treatment. Group 3 patients, who were in the fast-track pathway, were seen by spinal specialists.

The inclusion criteria were:
  • aged 18 years or older,
  • a clinical diagnosis of sciatica of any severity and duration following clinical assessment by a physiotherapist in the research clinics, and
  • had access to a mobile phone or landline.
Patients were excluded if:
  • they were receiving treatment or had received treatment in the last 3 months for the same problem;
  • they were pregnant;
  • they had previous lumbar spine surgery;
  • their general practitioner (GP) or the assessing physiotherapist suspected serious spinal pathology (e.g., cauda equina syndrome, fracture, spondyloarthropathy, malignancy, infection); or
  • they had serious physical or mental co-morbidities as judged by their GP or the assessing physiotherapist.
Patients were diagnosed with sciatica if the assessing physiotherapist was at least 70% confident in their clinical diagnosis. In addition, at least one of the following signs/symptoms had to be present:
  • leg pain approximating a dermatomal distribution;
  • leg pain worse than, or as bad as, back pain;
  • leg pain worse with coughing, sneezing, or straining;
  • subjective sensory changes approximating a dermatomal distribution;
  • objective neurological deficits indicative of nerve root compression;
  • positive neural tension test; and
  • (for spinal claudication or spinal stenosis) leg pain worse with weight-bearing activities and better with sitting.
Eligible patients were randomly assigned to one of two groups. Patients in one group received stratified care, in other words, treatment that was directed by the use of a simple tool that helps the clinician decide on the treatment pathway. Patients in the other group received usual care, where treatment was discussed and agreed on between the patient and physiotherapist.

Treatment was delivered by different physiotherapists to avoid contamination bias. The physiotherapists were not masked as to treatment allocation, although the statisticians and outcome assessors were.

Care for patients in the stratified arm was managed via the use of a stratification algorithm, whereby patients were allocated to one of three groups, as follows. Group 1 patients were offered brief advice and support in up to two physiotherapy sessions, Group 2 patients were offered up to six physiotherapy sessions, and group 3 patients were fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomization. The Group 1 and 2 treating physiotherapists could overrule the stratification algorithm if they thought it was appropriate.

Care for patients in the usual care arm was planned without the use of a stratification tool and further physiotherapy or referrals to other services were made at the discretion of the assessing physiotherapist in consultation with the patient.

The study’s primary outcome was time to first resolution of sciatica symptoms where “resolution” was defined as being “completely recovered” or “much better” as measured on a 6-point ordinal scale. To collect this data, patients responded to a text message that read: “Compared to how you were at the SCOPiC clinic X weeks/months ago, how are your back and leg symptoms today?” These data were collected weekly for the first 4 months and then every 4 weeks between 4- and 12-months’ follow-up, or until symptoms were resolved.

Secondary outcomes were collected via mailed questionnaires that included questions about 1) global perceived change, 2) physical function, 3) overall impact of sciatica symptoms, 4) back and leg pain intensity, 5) sleep disturbance, 6) fear of movement, 7) anxiety and depression, 8) risk of persistent back-pain related disability, 9) health-related quality of life (EuroQoL EQ-5D-5L), 10) general health, 11) neuropathic pain symptoms, 12) days lost from work and productivity loss due to sciatica, and 13) satisfaction with care. Additional data were collected on health-care resource use and the costs of care over 12 months.

The primary statistical analysis compared the time to self-reported resolution of symptoms between the stratified care and usual care arms over 12 months’ follow-up. The secondary outcomes were analyzed at 4 and 12 months using longitudinal mixed-effect regression models.

Study Strengths / Weaknesses

This was a well-conducted, pragmatic randomized clinical trial and its results are useful in informing clinical practice.

The trial had some particular strengths, including:
  • attainment of the target sample size;
  • a high follow-up rate for the primary outcome;
  • good adherence to matched care pathways in the stratified care arm; and
  • initial testing of the face validity of the stratified care model, which was developed by clinicians involved in the management of patients with sciatica and was developed with previous data from a similar primary care population.
The authors listed several study limitations, including:
  • the stratification algorithm was not externally validated before its use in this trial;
  • the trial design does not allow differentiation between the effect of the stratification algorithm (the subgrouping) from that of the matched care pathways; and
  • the trial was not powered to detect differences at the level of each of the three sciatica groups, so the conclusions only apply to the overall stratified care approach for patients with sciatica consulting in primary care.

Additional References:

  1. Rihn JA, Hilibrand AS, Radcliff K, et al. Duration of symptoms resulting from lumbar disc herniation: Effect on treatment outcomes. J Bone Joint Surg (Am) 2011; 93: 1906–14.
  2. Hill J, Whitehurst D, Lewis M, et al. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet 2011; 378: 1560–71.
  3. Foster N, Mullis R, Hill J, et al. Effect of stratified care for low back pain in family practice (IMPaCT Back): a prospective population-based sequential comparison. Ann Fam Med 2014; 12: 102–11.