Lumbar RadiculopathyB²asicNCT02630732
Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy?
A study testing Brain school and Back school in people with Lumbar Radiculopathy, run by Universitair Ziekenhuis Brussel at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Brain school and Back school
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesBelgium
- Study dates
- 23 Jun 2016to 26 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Sint-Maarten
Duffel, Antwerpen, 2570
AZ Sint-Dimpna
Geel, Antwerpen, 2440
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
About this study
Official title: Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? A Randomized Controlled Trial With Two-year Follow-up
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.
Read the 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.
- Conditions
- Lumbar Radiculopathy
- Being tested
- Brain school, Back school
- Keywords
- Back School, Brain School, Lumbar surgery, Education
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain schoolBehavioural
Also called pain education, perioperative pain neuroscience education
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.
Back schoolBehavioural
Also called classical 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.
| Study group | Role | What they receive |
|---|---|---|
| Brain School | Active comparator | Pain Neuroscience Education Program Receives: Behavioral: Brain school |
| Back School | Active comparator | Classical Back School Receives: Behavioral: Back school |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Postoperative healthcare expenditure includes the number of days spent in hospital following surgery and medical tests related to post-operative surgery.
Measured: 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
Measured: 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".
Surgical experience addresses the way the patient feels to be prepared for surgery, and the extent the surgery met patient's expectations.
Measured: 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
The pain catastrophizing scale consists of 13 items describing different thoughts and feelings that individuals may experience when they are experiencing pain.
Measured: 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.
The Pain Vigilance and Awareness Questionnaire is a 16-item measure of attention to pain that assesses awareness, consciousness, vigilance, and observation of pain.
Measured: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
Kinesiophobia with the Tampa Scale for Kinesiophobia
Measured: 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.
Patients will be asked to fulfil a demographic questionnaire concerning their grade of education, professional occupation, incomes and return to work.
Measured: 1 week before surgery (except for surgical experience), 3 days after surgery, 6weeks post operative, 6 months, 12 months and 24 months
Self-reported healthcare expenditure for which diaries will be used.
Self-reported healthcare expenditure includes the number of postsurgical treatments (e.g. pain killers, physiotherapy, psychotherapy, osteopathy).
Measured: The difference between 3 days post-surgery, 6weeks post-surgery, 6 months, 12 months and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2015 (estimated)
- Study start23 Jun 2016
- Primary completion26 Mar 2021
- Study completion26 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02630732
- Sponsor's protocol ID
- B²asic1
- Acronym
- B²asic
- Status last verified
- Jun 2021
- First submitted
- 25 Nov 2015
- Last updated
- 9 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
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, 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.
PubMed 23478459Dolphens 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.
PubMed 24885889Louw A LQ, Crous LCC. Preoperative education for lumbar surgery for radiculopathy. S Afr J Physiother. 2009;65:3 - 8.
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.
PubMed 24239490Louw 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.
PubMed 24875964Van 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.
PubMed 38575104Van 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.
PubMed 38189683Huysmans 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.
PubMed 37344337Van 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.
PubMed 34342846
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Back School or Brain School for Patients Undergoing Surgery for Lumbar Radiculopathy? A Randomized Controlled Trial With Two-year Follow-up
- ClinicalTrials.gov ID
- NCT02630732
- Acronym / sponsor ID
- B²asic / B²asic1
- Conditions
- Lumbar Radiculopathy
- Keywords
- Back School, Brain School, Lumbar surgery, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Vrije Universiteit Brussel
- Study start
- 23 Jun 2016 (actual)
- Primary completion
- 26 Mar 2021 (actual)
- Study completion
- 26 Mar 2021 (actual)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brain School | Active comparator | Behavioral: Brain schoolPain Neuroscience Education Program |
| Back School | Active comparator | Behavioral: Back schoolClassical Back School |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain schoolAlso: pain education, perioperative pain neuroscience education2 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. | Behavioural | Brain School |
| Back schoolAlso: classical back schoolTwo 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. | Behavioural | Back School |
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: 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.
8 secondary outcomes
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- BackgroundButler D, Moseley GL. Explain pain: Adelaide: NOI Group Publishing; 2003.
- Backgroundvan Wilgen CP, Nijs J. Pijneducatie: een praktische handleiding voor (para)medici: Bohn Stafleu van Loghum; 2010.
- BackgroundLouw A. Your Nerves Are Having Back Surgery. International Spine and Pain Institute, Minneapolis, U.S.A.; 2012.
- Background: PubMed 23478459Louw 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.
- Background: PubMed 24885889Dolphens 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.
- BackgroundLouw A LQ, Crous LCC. Preoperative education for lumbar surgery for radiculopathy. S Afr J Physiother. 2009;65:3 - 8.
- Background: PubMed 24239490Kreiner 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.
- Background: PubMed 24875964Louw 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.
- Derived from this study: PubMed 38575104Van 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.
- Derived from this study: PubMed 38189683Van 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.
- Derived from this study: PubMed 37344337Huysmans 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.
- Derived from this study: PubMed 34342846Van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain school and Back school in people with Lumbar Radiculopathy, run by Universitair Ziekenhuis Brussel at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02630732, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.