The PLUS Study: Preventing Lumbar disc surgery

Lumbar disc surgery rates in the Netherlands are high. It is estimated that
12,000 operations are performed yearly in the Netherlands. The incidence rate
of Lumbosacral Radicular Syndrome (LSRS) in general practice is 12 per 1,000
patients per year. The Dutch guideline 'Lumbosacral Radicular Syndrome (LSRS,
also known as sciatica)' recommends surgical treatment if the radiating leg
pain persists in spite of a period of conservative management.

A significant number of patients undergoing surgery for lumbar disc herniation
suffer residual complaints. Surgical and non-surgical management of lumbar
hernia are equally successful in the long term. However, withholding surgery to
patients whose complaints persist after often a long period of conservative
management is challenging. Although preventing surgery has the potential to
improve patient outcomes and reduce costs.

Results of our pilot study suggest that the provision of a combination therapy
consisting of Mechanical Diagnosis and Treatment (MDT) and Transforaminal
epidural steroid injections (TESIs) can lead to a reduction in the number of
operations (ie, only 22% of the patients underwent surgery after 1 year of
follow-up). However, our pilot study was not an RCT. We hypothesize that the
combination therapy will prevent at least 30% of the lumbar herniated disc
surgeries as compared to usual care (i.e. the wait list arm in our RCT).

The primary objective of this study is to assess the effectiveness and
cost-effectiveness in terms of the number of surgeries prevented of a
combination therapy versus usual care.
The secondary objective of this study is to assess the effectiveness and
cost-effectiveness in terms of pain (leg and back), functioning, self-perceived
recovery and health-related quality of life of a combination therapy versus
usual care.

Randomized controlled trial with economic evaluation (societal & healthcare
perspective). Treatment allocation is concealed. We will use one randomization
scheme per hospital (unit of randomization is patient).

The combination intervention (MDT and TESIs) will be administered as follows;
Using MDT principles and based on pain responses, participants are classified
as centralizers or non-centralizers. Centralizers get specific MDT exercises
and advice. Non-centralizers will be injected with dexamethasone 20 mg and
lidocaïne 0.5cc 2% under fluoroscopic guidance with contrast medium. If pain
reduction is less that 50%, then a second injection will be administered with
patient consent. After the injections, participants will be re-classified using
the same MDT principles into 4 subgroups. The subgroups are as follows;1)
resolved symptoms; 2) centralizing and significantly less pain, 3) non
centralizing and significantly less pain and 4) non-centralizing with high
levels of pain. In the first three groups mentioned here, patients will be
given advice and treated according to MDT principles with direction-specific
exercises and posture correction. Each subgroup will be treated by the MDT
therapist (1 to 6 session in on average 4 weeks). Only the patients in the
subgroup; non-centralising with high levels of pain will be referred back for
surgery.

Patients randomized to the control intervention group will placed on a waiting
list and scheduled to receive lumbar disc surgery within 2-4 months, if still
required. The aim of surgery is to remove the symptomatic disk herniation by a
minimal unilateral transflaval approach with magnification, with the patient
under general or spinal anesthesia.

The risks associated with participation in this study are equal to the risks
associated with daily practice. In the PLUS study we do not deviate from daily
practice. In the Netherlands patients suffering from sciatica can either
receive an operation or be treated using conservative methods. Conservative
methods include transforaminal steroid injections and physiotherapy/McKenzie
treatment, both of which are interventions offered in this study. Therefore
there is no risk to participants for taking part in this study.

Patients will be required to complete questionnaires at various moment and
this might be regarded as extra burden for patients.. The benefits of this
study will outweigh this extra burden. Currently more than 1.2 million per year
is associated with direct and indirect costs of sciatica in Netherlands. This
project will provide an answer to the question whether combination therapy is
cost effective compared to surgery in patients with lumbar hernia. The result
will guide evidence-based decision making for patients who (based on current
guidelines) undergo lumbar disc surgery. Thereby reducing the burden on
patients and society.