Clinical Trial: Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy?

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? A Randomized Controlled Trial With Two-year Follow-up

Brief 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 Summary:

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
Sponsor: Universitair Ziekenhuis Brussel

Current Primary Outcome:

• Self-reported pain assessed by the Visual Analogue Scale [ Time Frame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery ]
  Patients fill in the Visual Analogue Scale ( 0 no pain - 10 unbearable pain) for their perceived back and leg pain.
• Electrical pain threshold measured with an constant current electrical stimulator (DS7A Digitimer) [ Time Frame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery ]
  Determination of the electrical pain threshold with an electrical stimulator at the Median Nerve and Sural Nerves of each patient.
• Endogenous pain inhibition assessed by the conditioned pain modulation paradigm [ Time Frame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery ]
  Conditioned pain modulation will be tested with the electrical stimulator as test stimulus and the cold pressor (12 °C) as conditioning stimulus. The difference between the electrical pain threshold (baseline) and the electrical pain threshold during the cold pressor (baseline + cold pressor) is called the conditioned pain modulation effect.
• Quantitative Electroencephalography (QEEG) for brain mapping [ Time Frame: 
  
  

  Original Primary Outcome:

  • Self-reported pain assessed by the Visual Analogue Scale [ Time Frame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery ]
    Patients fill in the Visual Analogue Scale ( 0 no pain - 10 unbearable pain) for their perceived back and leg pain.
  • Pressure pain threshold measured with an algometer [ Time Frame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery ]
    Determination of the pressure pain threshold (kg/cm2) with an algometer at the hand, Quadriceps and calf of each patient.
  • Endogenous pain inhibition assessed by the conditioned pain modulation paradigm [ Time Frame: Change between baseline(1 week before surgery) and 3 days post-surgery, baseline and 6weeks post-surgery, baseline to 6 months post-surgery, baseline to 12 months post-surgery and baseline to 24 months post-surgery ]
    Conditioned pain modulation will be tested with the algometer as test stimulus and the cold pressor (12 °C) as conditioning stimulus. The difference between the pressure pain threshold measured with the algometer (baseline) and the pressure pain threshold during the cold pressor (baseline + cold pressor) is called the conditioned pain modulation effect.
  • Quantitative Electroencephalography (QEEG) for brain mapping [ Time Frame: Change between baseline(1 week before surger
    
    

    Current Secondary Outcome:

    • Postoperative healthcare expenditure for lumbar radiculopathy will be investigated by consultation of medical notes. [ Time Frame: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months ]
      Postoperative healthcare expenditure includes the number of days spent in hospital following surgery and medical tests related to post-operative surgery.
    • Functional status and well-being with the Short Form Health Survey-36 items [ Time Frame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months ]
    • Surgical experience assessed with statements about patients their spinal surgery/education experience with a level of agreement on a numerical scale from 1 "minimal" to 10 "maximal agreement". [ Time Frame: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months ]
      Surgical experience addresses the way the patient feels to be prepared for surgery, and the extent the surgery met patient's expectations.
    • Pain catastrophizing with the Dutch translation of the Pain Catastrophizing Scale [ Time Frame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months ]
      The pain catastrophizing scale consists of 13 items describing different thoughts and feelings that individuals may experience when they are experiencing pain.
    • Pain hypervigilance with the Dutch Pain Vigilance and Awareness Questionnaire. [ Time Frame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months ]
      The Pain Vigilance and Awareness Questionnaire is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.
    • Kinesiophobia with the Tampa Scale for Kinesiophobia [ Time Frame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months ]
    • Socio-economic factors with a demographic questionnaire concerning their return to work, professional occupation, incomes and grade of education. [ Time Frame: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months ]
      Patients will be asked to fulfil a demographic questionnaire concerning their grade of education, professional occupation, incomes and return to work.
    • Self-reported healthcare expenditure for which diaries will be used. [ Time Frame: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months ]
      Self-reported healthcare expenditure includes the number of postsurgical treatments (e.g. pain killers, physiotherapy, psychotherapy, osteopathy).
    
    
    

    Original Secondary Outcome: Same as current
    
    Information By: Universitair Ziekenhuis Brussel
    

    Dates:
    Date Received: November 25, 2015
    Date Started: January 2016
    Date Completion: August 2019
    Last Updated: July 29, 2016
    Last Verified: July 2016