Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154].

BACKGROUND: The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). METHODS/DESIGN: Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. DISCUSSION: Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery.

Westeinde sciatica trial: randomized controlled study of bed rest and physiotherapy for acute sciatica.

OBJECT: The authors conducted a study to compare the efficacies of three nonsurgical treatment strategies in patients with sciatica. Their hypothesis was that bed rest, physiotherapy, and continuation of activities of daily living (ADLs) (control treatment) are each of equivalent efficacy. METHODS: This randomized controlled trial was designed for comparison of bed rest, physiotherapy, and continuation of ADLs. The setting was an outpatient clinic. General practitioners were asked to refer patients for treatment as soon as possible. The authors enrolled 250 patients (< 60 years of age) with sciatica of less than 1-month's duration and who had not yet been treated with bed rest or physiotherapy. Primary outcome measures were radicular pain (based on a visual analog pain scale [VAPS]) and hampered ADLs (Quebec Disability Scale [QDS]). Secondary outcome measures were the rates of treatment-related failure and surgical treatment. Measures were assessed at baseline and during follow up at 1, 2, and 6 months. Mean differences in VAPS and QDS scores between bed rest and control treatment were 2.5 (95% confidence interval [CI] -6.4 to 11.4) and -4.8 (95% CI -10.6 to 0.9) at 1 month and 0.9 (95% CI -8.7 to 10.4) and -2.7 (95% CI -9.9 to 4.4) at 2 months, respectively. The respective differences between physiotherapy and control treatment were 0.8 (95% CI -8.2 to 9.8) and -0.5 (95% CI -6.3 to 5.3) at 1 month and -0.3 (95% CI -9.4 to 10) and 0.0 (95% CI -7.2 to 7.3) at 2 months. The respective odds ratios for treatment failure and surgical treatment of bed rest compared with control treatment were 1.6 (95% CI 0.8-3.5) and 1.5 (95% CI 0.7-3.6) at 6 months. When physiotherapy was compared with control treatment, these ratios were 1.5 (95% CI 0.7-3.2) and 1.2 (95% CI 0.5-2.9) at 6 months, respectively. CONCLUSIONS: Bed rest and physiotherapy are not more effective in acute sciatica than continuation of ADLs.