Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy?
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The primary scientific objective of the study entails examining whether perioperative pain
      neuroscience education (PPNE or 'brain school') is more effective than classical back school
      in reducing pain and improving pain inhibition in patients undergoing surgery for spinal
      radiculopathy. A secondary objective implies examining whether PPNE is more effective than
      classical back school in imparting a behavioural change (i.e. decreasing postoperative
      healthcare expenditure for lumbar radiculopathy), improving functioning in daily life and
      improving surgical experience (=better prepared for surgery, surgery meeting their
      expectations) in patients undergoing surgery for spinal radiculopathy.
    

Detailed description: 
      Prior to this study on lumbar radiculopathy patients, the proposed CPM protocol with EEG
      recordings will be pre-tested on a group of twenty healthy subjects, who will be fully
      informed about the study and subsequently gave their consent to participate. The proof of
      concept is set up to evaluate the effectiveness of the protocol, more specifically the
      appearance of nociceptive evoked potentials induced by electrical stimulation and the load on
      the subjects, as well as the safety of the protocol.

      Low back pain is a frequently reported problem in our community. In the absence of successful
      outcomes following conservative intervention, surgery (including lumbar discectomy) is a
      recommended, evidence-based treatment for lumbar radiculopathy. To prevent chronicity
      following spinal surgery, preoperative education seems to be warranted. Current preoperative
      education programs in the orthopaedic and neurosurgical domain typically rely on the
      biomedical model, including education about (spinal) anatomy and biomechanics (like done in
      'back schools'), as well as detailing the surgical procedure. Preoperative education
      focussing on the biomedical model is ineffective, and can increase anxiety and fear of
      patients undergoing spinal surgery. Therefore, there is a need to reconsider the content of
      education provided to patients undergoing spinal surgery.

      Patient recruitment. All patients scheduled for surgery for lumbar radiculopathy in the UZ
      Brussel will be invited to participate. Lumbar radiculopathy is defined as pain due to
      lumbosacral nerve root compression. The NICE guidelines describe this as unilateral leg pain
      worse than the current back pain. This pain radiates to the foot or toes, and goes together
      with numbness and paraesthesia in the same distribution, which is associated with motor
      neurological deficit. Patients undergoing surgery for lumbar radiculopathy (n ≥ 100), willing
      to participate (including willingness to comply with the predetermined follow-ups), are
      recruited.

      Randomization and concealment Randomization will be done by a computer-generated
      randomization list. A list with patient numbers and the group allocation that results from
      this randomization procedure will be stored in a sealed envelope. All the assessments will be
      performed by the same two investigators.

      Intervention. At least 50 patients undergoing surgery for lumbar radiculopathy should get the
      experimental treatment, i.e. perioperative pain neuroscience education (PPNE). All patients
      will receive usual care plus surgery for lumbar radiculopathy. PPNE will comprise of two
      treatment sessions delivered by one physiotherapist (verbal one-on-one) and an educational
      booklet. The first treatment session will be in the week before surgery, the second on day 2
      following surgery. Each treatment session will last approximately 60 minutes.

      Patients will receive pain neuroscience education and will have extensive possibilities to
      ask questions during the sessions. At the end of the first educational session, patients will
      receive the educational booklet about the neurophysiology of pain and will be asked to read
      it carefully once before and once following surgery. In addition, they will be asked to
      complete the interactive part in the book before the second session. The second educational
      session (postoperative) is highly individually-tailored as it will readdress the patient's
      illness perceptions, answers questions and discuss the way of applying the knowledge into the
      patient's daily life. Immediately after the second educational session the participants will
      be asked to complete the Neurophysiology of Pain Test.

      Control intervention. At least 50 patients should undergo the control treatment. As is the
      case with patients from the experimental group, patients in the control group will receive
      usual care plus surgery for lumbar radiculopathy. In addition to this standard treatment
      received by all patients included in the study, they will receive back school. The amount of
      therapist-patient contact, the number of treatment sessions as well as the mode of
      administration will be identical in both treatment groups. The procedure of the control
      treatment is identical to the experimental treatment, apart from the content of the
      treatment, which is based on the clinical guidelines and several studies. The education
      covers the normal course of back pain.

      Data collection. All assessments will be performed in the UZ Brussel. Baseline assessments
      will take place during the week prior to the surgery. Immediate treatment effects will be
      assessed at post-operative day 3. Short-term and intermediate follow-up assessments will take
      place at, respectively, 6 weeks and 6 months post-surgery. Twelve and 24 months after the
      surgery the long-term follow-up treatment effects will be investigated.

      Statistical analysis. At baseline, correlation analyses will be performed in order to examine
      possible associations between preoperative endogenous analgesia and the psychological
      factors.

      All postoperative data analyses will be based on the Intention-to-Treat principle (i.e. the
      baseline observation carried forward method). AN(C)OVA repeated measures analyses will be
      used to evaluate and compare treatment effects. Baseline data of the outcome measure of
      interest, age and gender will serve as covariates. Statistical, as well as clinical
      significant differences will be defined and the effect size will be determined. In addition,
      numbers needed to treat will be calculated. Again, correlation analyses will be performed to
      evaluate whether changes in any of the outcome measures are related to changes in the
      psychological factors.
    

Intervention name(s): Brain school; Back school
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 2 sessions of education provided by a therapist. The first session one day before surgery, the other two days after surgery. Education contains physiology of the central nerve system and the pain system. Information about acute pain, chronic pain and central sensitisation.; Two education sessions ( one day before surgery and two days after surgery) with information about the biomechanics of the lumbar spine, physiology of the spine and ergonomics.
Other intervention name(s): pain education, perioperative pain neuroscience education; classical back school
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Back School; Brain School; Lumbar surgery; Education