The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581).

BACKGROUND: Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of 'wait and see' for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. METHODS/DESIGN: Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the acceptability of stratified care. DISCUSSION: This paper presents the details of the rationale, design and processes of the SCOPiC trial. Results from this trial will contribute to the evidence base for management of patients with sciatica consulting in primary care. TRIAL REGISTRATION: ISRCTN75449581 , date: 20.11.2014.

Physical therapy plus general practitioners' care versus general practitioners' care alone for sciatica: a randomised clinical trial with a 12-month follow-up.

A randomised clinical trial in primary care with a 12-months follow-up period. About 135 patients with acute sciatica (recruited from May 2003 to November 2004) were randomised in two groups: (1) the intervention group received physical therapy (PT) added to the general practitioners' care, and (2) the control group with general practitioners' care only. To assess the effectiveness of PT additional to general practitioners' care compared to general practitioners' care alone, in patients with acute sciatica. There is a lack of knowledge concerning the effectiveness of PT in patients with sciatica. The primary outcome was patients' global perceived effect (GPE). Secondary outcomes were severity of leg and back pain, severity of disability, general health and absence from work. The outcomes were measured at 3, 6, 12 and 52 weeks after randomisation. At 3 months follow-up, 70% of the intervention group and 62% of the control group reported improvement (RR 1.1; 95% CI 0.9-1.5). At 12 months follow-up, 79% of the intervention group and 56% of the control group reported improvement (RR 1.4; 95% CI 1.1; 1.8). No significant differences regarding leg pain, functional status, fear of movement and health status were found at short-term or long-term follow-up. At 12 months follow-up, evidence was found that PT added to general practitioners' care is only more effective regarding GPE, and not more cost-effective in the treatment of patients with acute sciatica than general practitioners' care alone. There are indications that PT is especially effective regarding GPE in patients reporting severe disability at presentation.

Cost-effectiveness of physical therapy and general practitioner care for sciatica.

STUDY DESIGN: An economic evaluation alongside a randomized clinical trial in primary care. A total of 135 patients were randomly allocated to physical therapy added to general practitioners' care (n = 67) or to general practitioners' care alone (n = 68). OBJECTIVE: To evaluate the cost-effectiveness of physical therapy and general practitioner care for patients with an acute lumbosacral radicular syndrome (LRS, also called sciatica) compared with general practitioner care only. SUMMARY OF BACKGROUND DATA: There is a lack of knowledge concerning the cost-effectiveness of physical therapy in patients with sciatica. METHODS: The clinical outcomes were global perceived effect and quality of life. The direct and indirect costs were measured by means of questionnaires. The follow-up period was 1 year. The Incremental Cost-effectiveness Ratio (ICER) between both study arms was constructed. Confidence intervals for the ICER were calculated using Fieller's method and using bootstrapping. RESULTS: There was a significant difference on perceived recovery at 1-year follow-up in favor of the physical therapy group. The additional physical therapy did not have an incremental effect on quality of life. At 1-year follow-up, the ICER for the total costs was 6224 euros (95% confidence interval, -10,419, 27,551) per improved patient gained. For direct costs only, the ICER was 837 euros (95% confidence interval, -731, 3186). CONCLUSION: The treatment of patients with LRS with physical therapy and general practitioners'care is not more cost-effective than general practitioners'care alone.

The impact of disability compensation on long-term treatment outcomes of patients with sciatica due to a lumbar disc herniation.

STUDY DESIGN: Prospective, observational study. OBJECTIVE: To compare long-term disability and health-related quality of life outcomes of individuals receiving or not receiving workers' compensation at baseline evaluation. SUMMARY OF BACKGROUND DATA: Disability compensation has long been associated with poor clinical outcomes. However, most studies have assessed outcomes over short time periods using unvalidated measures without controlling for potential confounders. METHOD: Patients with sciatica due to a herniated lumbar disc were treated by physicians in community based orthopedic, neurosurgical, and occupational medicine practices throughout Maine. Outcomes assessed included disability compensation and work status, and health-related quality of life, controlling for initial treatment received and factors predicting initial workers' compensation status. RESULTS: Among 440 eligible patients, 172 (86%) receiving workers' compensation and 222 (92%) not receiving workers' compensation at baseline evaluation completed at least one follow-up between 5 and 10 years (80% completed 10-year). Baseline demographics, past back history, imaging findings, symptoms, functional status, and expectations significantly differed according to the patient's baseline workers' compensation status. After 5-10 years, most patients, regardless of baseline workers' compensation status (yes or no), were not receiving disability compensation (83% vs. 96%, respectively) and were employed (78% for both groups). However, workers' compensation patients were significantly more likely to be receiving disability compensation and had worse symptoms, functional status, and satisfaction outcomes. Outcome differences diminished in magnitude after controlling for baseline differences among patients receiving workers' compensation or not but continued to favor those not initially receiving workers' compensation. Initial treatment received, either surgical or nonsurgical, did not influence these findings. CONCLUSIONS: Long-term employment and disability outcomes were favorable for most patients with a disc herniation, regardless of initial workers' compensation status. However, individuals initially receiving workers' compensation had worse disability and quality of life outcomes compared to individuals not receiving workers' compensation. Despite these differences, long-term work outcomes were similarly favorable.

Return to work: conducting a worksite assessment.

George is a 46 year old who, at work, develops back pain with right sided sciatica. Initial findings include an absent right ankle jerk with sensory loss in the distribution of the right S1 nerve root. MRI scan confirms the diagnosis of an L5-S1 disc herniation with pressure on the right S1 nerve root. Following referral to a neurosurgeon he undergoes microdiscectomy. He is now six weeks postoperative. The scar healed well. His sciatica and ankle jerk have improved. He is now considering returning to work.

Assessment of functional status, low back disability, and use of diagnostic imaging in patients with low back pain and radiating leg pain.

We analyzed data from outpatients with chronic low back pain (LBP) in the Veterans Health Study (n = 563) to examine the relationship between localized LBP intensity and radiating leg pain in assessing patient functional status, low back disability, and use of diagnostic imaging. Based on the localized LBP intensity, the study subjects were divided into tertiles (low, moderate, and high intensity). The study subjects were also stratified by the extent of radiating leg pain. Using analysis of variance and multiple regression analysis, we compared the relative importance of localized LBP intensity and radiating leg pain in explaining the variability in the means of the SF-36 scales and low back disability days, and in the proportion of patients who had used diagnostic imaging. The results of the study indicate that measures of localized LBP intensity and radiating leg pain contribute separately to the assessment of patient functional status, low back disability, and use of diagnostic imaging. These results suggest that localized LBP intensity and radiating leg pain may represent two different approaches in assessing back pain severity. Future epidemiological and health services research should consider both measures in assessing the impact of LBP on patient functional status, low back disability, and use of diagnostic imaging.