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Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? (B²asic)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02630732
Recruitment Status : Active, not recruiting
First Posted : December 15, 2015
Last Update Posted : June 17, 2019
Sponsor:
Collaborator:
Vrije Universiteit Brussel
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Lumbar Radiculopathy Behavioral: Brain school Behavioral: Back school Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? A Randomized Controlled Trial With Two-year Follow-up
Study Start Date : January 2016
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Arm Intervention/treatment
Active Comparator: Brain School
Pain Neuroscience Education Program
Behavioral: Brain school
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.
Other Name: pain education, perioperative pain neuroscience education

Active Comparator: Back School
Classical Back School
Behavioral: Back school
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 Name: classical back school




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Quantitative Electroencephalography (QEEG) for brain mapping [ 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 ]
    During the conditioned pain modulation a QEEG is administered to examine the differences in brain activation on the brain map between the time frames.


Secondary Outcome Measures :
  1. 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.

  2. 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 ]
  3. 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.

  4. 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.

  5. 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.

  6. 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 ]
  7. 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.

  8. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery for radiculopathy
  • Speaking and reading Dutch fluently
  • 18-65 years old
  • Continuing usual care ( no new treatment) 6 weeks preceding surgery and during trial

Exclusion Criteria:

  • Surgery for another condition than radiculopathy
  • Symptoms of cord compression
  • Rheumatoid, endocrinological, neurological or psychiatric disorder
  • Chronic illness characterized by chronic pain that is not under control
  • New treatments 6 weeks preceding surgery
  • Pregnancy (preceding year)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630732


Locations
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Belgium
Sint-Maarten
Duffel, Antwerpen, Belgium, 2570
AZ Sint-Dimpna
Geel, Antwerpen, Belgium, 2440
Universitair Ziekenhuis Brussel
Jette, Brussel, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel

Publications:
Butler D, Moseley GL. Explain pain: Adelaide: NOI Group Publishing; 2003.
van Wilgen CP, Nijs J. Pijneducatie: een praktische handleiding voor (para)medici: Bohn Stafleu van Loghum; 2010.
Louw A. Your Nerves Are Having Back Surgery. International Spine and Pain Institute, Minneapolis, U.S.A.; 2012.
Louw A LQ, Crous LCC. Preoperative education for lumbar surgery for radiculopathy. S Afr J Physiother. 2009;65:3 - 8.

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02630732    
Other Study ID Numbers: B²asic1
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Keywords provided by Universitair Ziekenhuis Brussel:
Back School
Brain School
Lumbar surgery
Education
Additional relevant MeSH terms:
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Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases