BACKGROUND: Sciatica has a substantial impact on patients and society. Current care is 'stepped', comprising an initial period of simple measures of advice and analgesia, for most patients, commonly followed by physiotherapy, and then by more intensive interventions if symptoms fail to resolve. No study has yet tested a model of stratified care in which patients are subgrouped and matched to different care pathways based on their prognosis and clinical characteristics.
OBJECTIVES: The objectives were to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care.
DESIGN: This was a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial.
SETTING: Participants were recruited from primary care (42 general practices) in North Staffordshire, North Shropshire/Wales and Cheshire in the UK.
PARTICIPANTS: Eligible patients were aged = 18 years, had suspected sciatica, had access to a mobile phone/landline, were not pregnant, were not receiving treatment for the same problem and had not had previous spinal surgery.
INTERVENTIONS: In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Group 1 received advice and up to two sessions of physiotherapy, group 2 received up to six sessions of physiotherapy, and group 3 was fast-tracked to magnetic resonance imaging and spinal specialist opinion. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. Patients were randomised using a remote web-based randomisation service.
MAIN OUTCOME MEASURES: The primary outcome was time to first resolution of sciatica symptoms (six point ordinal scale, collected via text messages). Secondary outcomes (at 4 and 12 months) included pain, function, psychological health, days lost from work, work productivity, satisfaction with care and health-care use. A cost-utility analysis was undertaken over 12 months. A qualitative study explored patients' and clinicians' views of the fast-track care pathway to a spinal specialist.
RESULTS: A total of 476 patients were randomised (238 in each arm). For the primary outcome, the overall response rate was 89.3% (88.3% and 90.3% in the stratified and usual care arms, respectively). Relief from symptoms was slightly faster (2 weeks median difference) in the stratified care arm, but this difference was not statistically significant (hazard ratio 1.14, 95% confidence interval 0.89 to 1.46; p = 0.288). On average, participants in both arms reported good improvement from baseline, on most outcomes, over time. Following the assessment at the research clinic, most participants in the usual care arm were referred to physiotherapy.
CONCLUSIONS: The stratified care model tested in this trial was not more clinically effective than usual care, and was not likely to be a cost-effective option. The fast-track pathway was felt to be acceptable to both patients and clinicians; however, clinicians expressed reluctance to consider invasive procedures if symptoms were of short duration.
LIMITATIONS: Participants in the usual care arm, on average, reported good outcomes, making it challenging to demonstrate superiority of stratified care. The performance of the algorithm used to allocate patients to treatment pathways may have influenced results.
FUTURE WORK: Other approaches to stratified care may provide superior outcomes for sciatica.
TRIAL REGISTRATION: Current Controlled Trials ISRCTN75449581.
FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 49. See the NIHR Journals Library website for further project information.
|Rehab Clinician (OT/PT)|
The authors designed a two-parallel group, multicentre, pragmatic, 1 : 1 randomised controlled trial in order to investigate the clinical effectiveness and cost-effectiveness of a stratified care model compared with usual, non-stratified care in the treatment of sciatica. In stratified care, a combination of prognostic and clinical criteria associated with referral to spinal specialist services was used to allocate patients to one of three groups for matched care pathways. Usual care was based on the stepped-care approach without the use of any stratification tools/algorithms. The primary outcome was time to first resolution of sciatica symptoms. A total of 476 patients were randomised. The response rate was 88.3% and 90.3% in the stratified and usual care arms, respectively. Relief from symptoms was slightly faster in the stratified care arm. The stratified care model tested was not more clinically effective than usual care, and was not likely to be a cost-effective option.
This is mainly useful for primary care but it is extensive and long.
Arguably the most useful finding of this study is: "Further research should try to identify factors consistently and differentially associated with outcome or treatment effect in sciatica patients, to inform new stratified care models for sciatica."
It is a very useful study for clinical practice guidance.
Risk stratification has been found to improve patient outcomes in other LBP trials; this study did not provide enough details on methods to understand how their approach compared to other approaches.
The article is interesting likely to physiotherapists and possibly to OTs who work in the area of work rehabilitation.
These findings support the idea that some more invasive interventions and specialised radiology are not always the answer, even in patients with more severe pain. Even in these patients, physiotherapy can achieve very good short and long-term results.