Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy?

NCT02630732 | Completed

• 1 other identifier: B²asic1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Lumbar Radiculopathy

Keywords

Back School; Brain School; Lumbar surgery; Education

Outcome Measures

Primary Outcomes (4)

• Self-reported pain assessed by the Visual Analogue Scale

  Patients fill in the Visual Analogue Scale ( 0 no pain - 10 unbearable pain) for their perceived back and leg pain.

  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

• Electrical pain threshold measured with an constant current electrical stimulator (DS7A Digitimer)

  Determination of the electrical pain threshold with an electrical stimulator at the Median Nerve and Sural Nerves of each patient.

  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

• Endogenous pain inhibition assessed by the conditioned pain modulation paradigm

  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.

  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

• Quantitative Electroencephalography (QEEG) for brain mapping

  During the conditioned pain modulation a QEEG is administered to examine the differences in brain activation on the brain map between the time frames.

  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

Secondary Outcomes (8)

• Postoperative healthcare expenditure for lumbar radiculopathy will be investigated by consultation of medical notes.

  The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months

• Functional status and well-being with the Short Form Health Survey-36 items

  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".

  The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months

• Pain catastrophizing with the Dutch translation of the Pain Catastrophizing Scale

  1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months

• Pain hypervigilance with the Dutch Pain Vigilance and Awareness Questionnaire.

  1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months

Study Arms (2)

Brain School

ACTIVE COMPARATOR

Pain Neuroscience Education Program

Behavioral: Brain school

Back School

ACTIVE COMPARATOR

Classical Back School

Behavioral: Back school

Interventions

Brain school BEHAVIORAL

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.

Also known as: pain education, perioperative pain neuroscience education

Brain School

Back school BEHAVIORAL

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.

Also known as: classical back school

Back School

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• Vrije Universiteit Brussel: collaborator

Study Sites (3)

Sint-Maarten

Duffel, Antwerpen, 2570, Belgium

Location

AZ Sint-Dimpna

Geel, Antwerpen, 2440, Belgium

Location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (12)

• Butler D, Moseley GL. Explain pain: Adelaide: NOI Group Publishing; 2003.

  BACKGROUND

• van Wilgen CP, Nijs J. Pijneducatie: een praktische handleiding voor (para)medici: Bohn Stafleu van Loghum; 2010.

  BACKGROUND

• Louw A. Your Nerves Are Having Back Surgery. International Spine and Pain Institute, Minneapolis, U.S.A.; 2012.

  BACKGROUND

• Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4.

  PMID: 23478459 BACKGROUND

• Dolphens M, Nijs J, Cagnie B, Meeus M, Roussel N, Kregel J, Malfliet A, Vanderstraeten G, Danneels L. Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial. BMC Musculoskelet Disord. 2014 May 8;15:149. doi: 10.1186/1471-2474-15-149.

  PMID: 24885889 BACKGROUND

• Louw A LQ, Crous LCC. Preoperative education for lumbar surgery for radiculopathy. S Afr J Physiother. 2009;65:3 - 8.

  BACKGROUND

• Kreiner DS, Hwang SW, Easa JE, Resnick DK, Baisden JL, Bess S, Cho CH, DePalma MJ, Dougherty P 2nd, Fernand R, Ghiselli G, Hanna AS, Lamer T, Lisi AJ, Mazanec DJ, Meagher RJ, Nucci RC, Patel RD, Sembrano JN, Sharma AK, Summers JT, Taleghani CK, Tontz WL Jr, Toton JF; North American Spine Society. An evidence-based clinical guideline for the diagnosis and treatment of lumbar disc herniation with radiculopathy. Spine J. 2014 Jan;14(1):180-91. doi: 10.1016/j.spinee.2013.08.003. Epub 2013 Nov 14.

  PMID: 24239490 BACKGROUND

• Louw A, Diener I, Landers MR, Puentedura EJ. Preoperative pain neuroscience education for lumbar radiculopathy: a multicenter randomized controlled trial with 1-year follow-up. Spine (Phila Pa 1976). 2014 Aug 15;39(18):1449-57. doi: 10.1097/BRS.0000000000000444.

  PMID: 24875964 BACKGROUND

• Van Bogaert W, Huysmans E, Coppieters I, Nijs J, Putman K, Ickmans K, Moens M, Goudman L, Stas L, Buyl R. The Mediating Role of Pain Cognitions and Pain Sensitivity in the Treatment Effect of Perioperative Pain Neuroscience Education in People Undergoing Surgery for Lumbar Radiculopathy. J Pain. 2024 Aug;25(8):104521. doi: 10.1016/j.jpain.2024.03.017. Epub 2024 Apr 2.

  PMID: 38575104 DERIVED

• Van Bogaert W, Coppieters I, Nijs J, Buyl R, Ickmans K, Moens M, Goudman L, Putman K, Huysmans E. Influence of Preoperative Pain, Cognitions, and Quantitative Sensory Testing Measures on the Effects of Perioperative Pain Neuroscience Education for People Receiving Surgery for Lumbar Radiculopathy: Secondary Analysis of a Randomized Controlled Trial. J Orthop Sports Phys Ther. 2024 Apr;54(4):279-288. doi: 10.2519/jospt.2024.12051.

  PMID: 38189683 DERIVED

• Huysmans E, Goudman L, Coppieters I, Van Bogaert W, Moens M, Buyl R, Nijs J, Louw A, Logghe T, Putman K, Ickmans K. Effect of perioperative pain neuroscience education in people undergoing surgery for lumbar radiculopathy: a multicentre randomised controlled trial. Br J Anaesth. 2023 Sep;131(3):572-585. doi: 10.1016/j.bja.2023.05.007. Epub 2023 Jun 19.

  PMID: 37344337 DERIVED

• Van Bogaert W, Putman K, Coppieters I, Goudman L, Nijs J, Moens M, Buyl R, Ickmans K, Huysmans E. Health-related quality of life deviations from population norms in patients with lumbar radiculopathy: associations with pain, pain cognitions, and endogenous nociceptive modulation. Qual Life Res. 2022 Mar;31(3):745-757. doi: 10.1007/s11136-021-02964-5. Epub 2021 Aug 3.

  PMID: 34342846 DERIVED

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 15, 2015
• Study Start: June 23, 2016
• Primary Completion: March 26, 2021
• Study Completion: March 26, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

BE (3)