Margareta C Nordin, Federico Balagué
Evid Based Med. 2013;18(2):63-64.
Abstract
Commentary on: Albert HB, Manniche C. The efficacy of systematic active conservative treatment for patients with severe sciatica: a single-blind, randomized, clinical, controlled trial. Spine (Phila Pa 1976) 2012;37:531–42.
Context
The role of conservative treatment and exercise still remain uncertain for severe sciatica.
Methods
This prospective single-blind, randomised, controlled trial compares two active exercise programmes for patients with severe sciatica. In the county of Funen, patients are referred by general practitioners, rheumatologists or chiropractors to a state funded regional facility ‘Back Center Funen’ for specialty care. The two treatment arms proposed are identical except for the exercise regimens; both groups received thorough information (anatomy of the spine, the pathogenesis of a herniated disc and the natural healing process); a special emphasis was made on the positive prognosis of sciatica. The exercise regimens differed; one group received symptom-guided exercises according to McKenzie (directional exercises) and stabilising exercises for the trunk. The comparison group received sham exercises not related to the back or lumbar spine but rather low-dose exercise to simulate an increase in systemic blood circulation such as walking. Treatment lasted for 8weeks. Medication was not controlled, only paracetamol and/or non-steroidal anti-inflammatory drugs (NSAIDs) were recommended. Patients were recommended not to receive any other treatment during the trial. Two treatment teams carried out the treatment; one team was allocated to the sham exercise and another to symptom-guided exercise. An independent observer performed the history and a clinical examination at study entrance, treatment exit and follow-up of 1year.
Primary outcomes are pain scores on the Danish version of Roland Morris Disability Questionnaire and the Low Back Pain Rating Scale. Both scales are referenced for reliability/validity in the Danish population. Clinically important cut-offs are decided in advance. Secondary outcomes are the EuroQOL (EQ-5D) a well-validated scale. Sick leave over 1year is self-reported by the patients.
A sample calculation was done before the study start and no interim analysis was performed during the study. The statistical analyses are by intent to treat analysis and are adequate. There was a low-drop-out rate and did not change the overall results in the intent to treat analysis.
Findings
The results of the two regimens were comparable. The outcomes are similar, and clinically relevant, with a slight preference for the symptom-guided exercise group for treatment outcomes (positive straight leg raising, motor deficit, disturbed sensibility at end of treatment and 1-year follow-up). One patient was referred to surgery consultation in the symptom guided group and five patients in the sham exercise group. Self-reported sick leave was also more reported in the sham exercise group compared to the symptom guided group of patients.
Commentary
What do we learn from this study? Perhaps the most important finding is the good natural course of chronic sciatica for middle aged patients with a severity of leg pain ranging from 3 to 7 of 10. Clinicians can now comfortably use this information for their patients.[1–3]
Disc herniation was ascertained by MRI. However, no specificity or sensitivity of the MRI is given. It is possible that patients with spinal stenosis (bilateral leg symptoms) are included as subjects. All treatments took place in the centre and it is unclear how much contamination there was between the patients and possibly also therapists, an issue not addressed by the authors. The study suffers from not having a control group where no treatment was given, perhaps the natural history of non-acute sciatica is positive with no treatment at all, this study does not answer that question.
Exercise treatment works and a slight preference is shown for symptom-guided exercise in three areas; the difference is borderline and most prominent for leg pain (p=0.06). The proportion of patients reporting clinical recovery after treatment and sustained recovery after 1year is also 10–20% higher in the symptom-guided individual treatment. This study relies heavily on clinical skills and the lack of information about intertester reliability reduces the confidence. There is little information about possible other confounders in the study which would have enhanced the study. Finally, no weaknesses of the study are discussed by the authors, common practice today. The conclusions of the study may be a bit overstated for the symptom-guided exercise compared with sham exercises.
References
Balagué F, Nordin M, Sheikhzadeh A, et al. Recovery of impaired muscle function in severe sciatica. Eur Spine J 2001;10:242–9.
Jacobs WC, van Tulder M, Arts M, et al. Surgery versus conservative management of sciatica due to a lumbar herniated disc: a systematic review. Eur Spine J 2011;20:513–22. Review.
Ashworth J, Konstantinou K, Dunn KM. Prognostic factors in non-surgically treated sciatica: a systematic review. BMC Musculoskelet Disord 2011;12:208.