Cost‐effectiveness of combination therapy among patients with a Lumbar Herniated Disc surgery
Lumbar disc herniation, also known as sciatica, is the most common cause of lumbosacral radicular syndrome (LRS). Characteristics of LRS can be described by radiating pain in the lower limbs in a certain dermatome, which can be accompanied by sensory and / or motor deficits.
There are indications that the pathophysiology of LRS is not attributed to pressure on the nerve roots alone, but to a complex interplay of inflammatory, immunological and pressure-related processes. Estimated LRS incidence in Western countries is 5 per 1,000. In the Netherlands, the incidence of LRS in general practice is 12 per 1,000 patients per year. The direct and indirect costs of LRS are estimated annually at €1.2 billion in the Netherlands.
A randomized controlled trial will be conducted with an economic evaluation. Patients 18 years and older with debilitating LRS, leg pain and an indication for a hernia surgery confirmed by MRI are being recruited from seven Dutch hospitals. While on the waiting list for lumbar hernia surgery, patients are randomized to the combination therapy or the usual care group. The primary outcome measure is the number of patients undergoing lumbar disc surgery during a 12-month follow-up. Secondary results include back and leg pain intensity (numerical pain scale), physical functioning (Roland Morris Disability Questionnaires - 23), self-perceived recovery (overall perceived effect) and health-related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ - 5D - 5L) and 12-item Short Form Health Survey (SF - 12)). Social and healthcare costs are measured for the economic evaluation. Measuring moments are baseline, 1, 2, 4, 6, 9 and 12 months. All data will be analyzed according to the intention-to-treat principle.
The general consensus is that surgical treatment is advised when conservative methods fail in patients with lumbosacral radicular syndrome (LRS). Preliminary evidence from the pilot study indicates that combination therapy (mechanical diagnosis therapy and transforaminal epidural injections) can prevent surgical treatment of patients on the waiting list for surgery. A control group was missing in the pilot study. For this reason, no definitive conclusions could be drawn regarding securities. The aim of this study is to determine whether combination therapy performed while on the waiting list for lumbar hernia surgery is effective and cost-effective compared to conventional care (ie no intervention while on the waiting list) in patients with magnetic resonance imaging (MRI) ) - Confirmed indication for lumbar hernia surgery.
The importance of this study is further emphasized by the fact that there are major regional and international discrepancies in the treatment of lumbar disc herniation. Moreover, many costs and burdens for society are associated with LRS. For this reason, combination therapy can benefit society as a whole in addition to individual patients. As far as the researchers are aware, this is the first randomized controlled study to investigate the effectiveness and cost-effectiveness of the combination therapy in patients with LRS compared to conventional care.
It is concluded that randomized controlled trials have not evaluated the effectiveness and cost-effectiveness of combination therapy compared to the usual care in patients with an indication for lumbar hernia surgery, which emphasizes the importance of this study.
Physical Therapy Science