Abstract
Physicians often encounter surgical candidates with lumbar disc herniation (LDH) who request non-surgical management even though surgery is recommended. However, second opinions may differ among doctors. Therefore, a prospective comprehensive cohort study (CCS) was designed to assess outcomes of nonsurgical treatment for surgical candidates who were recommended to undergo surgery for LDH but requested a second opinion. The CCS includes both randomized and observational cohorts, comprising a nonsurgery cohort and surgery cohort, in a parallel fashion. Crossover between the nonsurgery and surgery cohorts was allowed at any time. The present study was an as-treated interim analysis of 128 cases (nonsurgery cohort, n = 71; surgery cohort, n = 57). Patient-reported outcomes included visual analogue scores for the back (VAS-B) and leg (VAS-L), the Oswestry Disability Index, the EuroQol 5-Dimension instrument, and the 36-Item Short-Form Health Survey (SF-36), which were evaluated at baseline and at 1, 3, 6, 12, and 24 months. At baseline, age and SF-36 physical function were significantly lower in the surgery cohort than in the nonsurgery cohort (p < 0.05). All adjusted outcomes significantly improved after both nonsurgical and surgical treatment (p < 0.05). The nonsurgery cohort showed less improvement of VAS-B and VAS-L scores at 1 month (p < 0.01), but no difference between cohorts was observed thereafter for 24 months (p > 0.01). Nonsurgical management may be a negotiable option even for surgical candidates in the shared decision-making process.
Highlights
Physicians often encounter surgical candidates with lumbar disc herniation (LDH) who request nonsurgical management even though surgery is recommended
≥ 18 years of age Symptomatic single-level lumbar disc herniation (LDH) documented by magnetic resonance imaging (MRI) taken within 3 months from the clinic visit date Intractable leg pain of more than 5/10 on a visual analogue scale (VAS) for at least 6 weeks despite active non-surgical treatments such as exercise, physiotherapy, medications, or epidural injections Concordant neurological symptoms and signs such as numbness, radiating pain, mild weakness, and/or limitations on the straight leg raise test (< 60°) Voluntarily agree to study participation and sign a written informed consent form Fully understand the details of a clinical study and those who are cooperative
The data for 50/71 (70.4%) patients in the nonsurgery cohort and 44/57 (77.2%) patients in the surgery cohort were available for analysis at 24 months (Fig. 2)
Summary
Physicians often encounter surgical candidates with lumbar disc herniation (LDH) who request nonsurgical management even though surgery is recommended. A prospective comprehensive cohort study (CCS) was designed to assess outcomes of nonsurgical treatment for surgical candidates who were recommended to undergo surgery for LDH but requested a second opinion. ≥ 18 years of age Symptomatic single-level lumbar disc herniation (LDH) (protrusion, extrusion, or sequestration) documented by magnetic resonance imaging (MRI) taken within 3 months from the clinic visit date Intractable leg pain of more than 5/10 on a visual analogue scale (VAS) for at least 6 weeks despite active non-surgical treatments such as exercise, physiotherapy, medications, or epidural injections Concordant neurological symptoms and signs such as numbness, radiating pain, mild weakness (stronger than manual motor power grade IV/V), and/or limitations on the straight leg raise test (< 60°) Voluntarily agree to study participation and sign a written informed consent form Fully understand the details of a clinical study and those who are cooperative. The aim of this article is to provide the results of the interim analysis
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