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Lumbar RadiculopathyB²EARSNCT05047679

The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy

A study testing Perioperative Pain Neuroscience Education and Perioperative Biomedical Education in people with Lumbar Radiculopathy, run by Vrije Universiteit Brussel at 4 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to assess the effectiveness of perioperative pain neuroscience education (PPNE) in patients who are at risk for unfavorable outcome following surgery for lumbar radiculopathy. Although most of these surgeries are successful, 23-28% of patients report chronic pain and disability following surgery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lumbar Radiculopathy
What is being tested?
Perioperative Pain Neuroscience Education and Perioperative Biomedical Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
4 sitesBelgium
Study dates
30 Sep 2021to 16 Oct 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for surgery for lumbar radiculopathy
  • Aged 18 years or older
  • Willing to comply with pre-determined follow-up
  • Speaking and reading Dutch fluently
  • No new treatments/medication 3 weeks prior to participation and during the trial
  • Having chronic back and/or leg pain ≥ 6 months
  • Scoring ≥ 37/68 on the Tampa Scale for Kinesiophobia
  • Scoring ≥ 30/52 on the Pain Catastrophizing Scale

Who cannot join

  • Surgery for another condition
  • Symptoms of cord compression or bilateral leg pain
  • Other chronic illness characterized by chronic pain
  • Other chronic rheumatoid, neurological, endocrinological, psychiatric or cognitive disorders
  • Indicated cognitive impairment (Scoring ≤11/15 on the 5-min Telephone Montreal Cognitive Assessment)
  • Pregnant or have given birth during the past year
  • No access to computer, or mobile device at home
  • Complications during the surgery

Trial locations and contacts

4 sites in 1 country.

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • AZ Rivierenland

    Bornem, Antwerpen, 2880

  • AZ Sint-Dimpna

    Geel, Antwerpen, 2440

  • Universitair Ziekenhuis Brussel

    Jette, Brussels Capital, 1090

Other trials in Belgium

About this study

Official title: The Effectiveness of Pain Neuroscience Education in Patients at Risk for Unfavorable Outcome Following Surgery for Lumbar Radiculopathy: A Multicentric Randomized Controlled Trial

This study aims to assess the effectiveness of perioperative pain neuroscience education (PPNE) in patients who are at risk for unfavorable outcome following surgery for lumbar radiculopathy. Although most of these surgeries are successful, 23-28% of patients report chronic pain and disability following surgery. Many preoperative factors are associated with an unfavorable surgical outcome, including maladaptive cognitive and emotional factors. Yet, current preoperative education, which focuses on anatomy and biomechanics of the lumbar spine, is ineffective in changing those maladaptive factors. PPNE was introduced as an innovative therapy that addresses modifiable risk factors in patients undergoing surgery for lumbar radiculopathy. PPNE reconceptualizes pain, informs patients about their pain development and is well established for improving maladaptive cognitions in several chronic pain-populations. Hence, we hypothesize that PPNE will be more effective than perioperative biomedical education in improving postsurgical quality of life, pain, analgesic use and return to work in patients at risk for unfavorable outcome following surgery for lumbar radiculopathy. First, a multicentric randomized controlled trial will compare the therapy effects of PPNE to perioperative biomedical education in these at-risk patients. Next, the mediating role of changes in maladaptive cognitions, such as fear of movement and pain catastrophizing, on the therapy effect of PPNE will be investigated.

Read the detailed description

Study rationale: Lumbar radiculopathy is described as uni- or bilateral leg pain which is often worse than back pain, with pain radiating in the related dermatomes and possible associations with sensory and/or motor symptoms or even deficits. Although surgical intervention for lumbar radiculopathy is often considered anatomically successful, several patients undergoing similar surgeries continue to experience pain and disability. Furthermore, patients developing such an unfavorable outcome also report decreased quality of life values, as well as an increase in analgesic use and health care utilization. Such unfavorable outcome is associated with a multitude of preoperative factors, including but not limited to maladaptive cognitive and emotional factors (e.g., fear of movement, pain catastrophizing, anxiety, distress and depression), preexisting chronic pain and long duration of preoperative sick leave. In line with this, it has been suggested that maladaptive psychological factors require special attention and optimization before surgery. Perioperative pain neuroscience education (PPNE) is such an intervention addressing these maladaptive psychological factors, such as fear of movement and pain catastrophizing. Therefore, a study assessing the effectiveness of PPNE on surgical outcome in at-risk patients undergoing surgery for lumbar radiculopathy is warranted.

Rationale for study design: The present study builds on the evidence provided by the study of Louw et al. (2014 \& 2016) which was a randomized controlled trial comparing PPNE with no supplemental intervention in patients undergoing surgery for lumbar radiculopathy. As such, we will conduct a multicentric randomized controlled trial investigating the therapy effect of PPNE specifically in patients with lumbar radiculopathy at risk for unfavorable surgical outcome. Doing this we will address several knowledge gaps by comparing two balanced therapy groups (PPNE vs perioperative biomedical education (PBE)), therefore overcoming potential bias due to unbalanced treatment arms, by adding several relevant outcome measures, and by targeting high-risk patients rather than all patients undergoing surgery.

Study objectives: The primary objective is to examine whether PPNE is more effective than PBE in improving postoperative quality of life at 6 weeks follow-up in patients undergoing surgery for lumbar radiculopathy at risk for unfavorable surgical outcome. Secondary objectives include: 1) to explore baseline associations between pain cognitions, quality of life and pain in patients scheduled for surgery for lumbar radiculopathy at risk for unfavorable outcome; 2) to examine whether PPNE is more effective than PBE in obtaining good surgical results concerning quality of life, pain, analgesic use, return to work, self-reported symptoms of central sensitization and pain cognitions at 6 weeks, 6 months and 1 year post-surgery and 3) to reveal the mediating role of changes in pain cognitions in the mechanism behind the therapy effect of PPNE in patients undergoing surgery for lumbar radiculopathy at risk for unfavorable outcome.

Study design: This study is a randomized controlled trial with one-year follow-up using preoperative patient screening based on chronic pain (≥ 6 months), kinesiophobia (Tamp Scale for Kinesiophobia ≥ 37/68) and pain catastrophizing (Pain Catastrophizing Scale ≥ 30/52). Eligible patients undergoing surgery for lumbar radiculopathy will be randomized and receive either the experimental intervention, i.e., PPNE, or the control intervention, i.e., PBE. Follow-up assessments will be organized at 6 weeks, 6 months and 12 months following the surgery.

Patient recruitment: All patients scheduled for surgery for lumbar radiculopathy in one of the participating hospitals will be contacted by telephone by the coordinating investigator. First, patients will be informed about the project and asked if they are willing to participate. When patients agree with participating in the study, they will be screened for potential eligibility using the in- and exclusion criteria. Following the initial screening, patients will have to meet an additional set of presurgical criteria (i.e., chronic pain, pain catastrophizing and kinesiophobia) to assess whether they are at risk for unfavorable surgical outcome, and therefore eligible for inclusion in the study sample. To screen for these presurgical criteria, patients eligible for further screening after the initial telephone interview, will be asked to complete an online survey questioning the three aforementioned criteria. The first page of the online survey will inform the patients once again about the goal of the screening and all patients will have to indicate their consent (by checking a box) before they can proceed to the actual questionnaire.

Randomization and blinding procedures: Following baseline assessments, participants will be randomized to one of both treatment groups. Concealed randomization will be prepared using a stratified permuted block allocation with stratification for treatment center. Randomization will be executed by an independent researcher who is not involved in the recruitment, assessments, treatment provision or statistical analyses. Patients will not know whether the intervention they receive is the experimental or the control intervention, however they will of course be aware of the content of the received intervention. A co-investigator, who will be responsible for baseline assessment and all follow-up assessments, will also be blinded to group allocation. With regard to this, patients will be asked not to communicate with the co-investigator about the intervention they received. The therapists providing the experimental treatment will not be involved in providing the control intervention and vice versa.

Sample size: Sample size was calculated to be 108 (54 per intervention group) based on a medium effect size of 0.6, α of 0.05, desired power of 0.80, an allocation ratio (N2/N1) of 1 and an anticipated loss to follow-up of 20%. A longitudinal pilot study in patients undergoing surgery for lumbar radiculopathy and who were retrospectively selected based on chronic pain (≥3 months), kinesiophobia (Tampa Scale for Kinesiophobia ≥37/68) and pain catastrophizing (Pain Catastrophizing Scale ≥30/52) was performed and evaluated the effect of PPNE on Short-Form 36-item, these results were used to determine the effect size for the sample size calculation.

Statistical analysis: Descriptive and correlation analyses will be performed on the baseline data. An AN(C)OVA repeated measures analysis will be used to evaluate treatment effects (primary and secondary objective). Lastly, a mediation analysis will be performed to examine the potential mediating role of changes in pain cognitions on the therapy effect of PPNE on quality of life.

Being tested
Perioperative Pain Neuroscience Education, Perioperative Biomedical Education
Keywords
Biomedical Education, Pain Neuroscience Education, Lumbar surgery, Education, Chronic pain, Kinesiophobia, Catastrophization, Perioperative Education
Medical subject headings
Radiculopathy, Chronic Pain, Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Perioperative Pain Neuroscience EducationBehavioural

    Also called Pain Education

    Perioperative pain neuroscience education addresses modifiable preoperative risk factors, and in particular cognitive and emotional risk factors, such as fear of movement and pain catastrophizing (i.e., excessively negative orientation toward pain). This education is a cognitive-based therapeutic intervention which reconceptualizes pain, informs patients about what to expect from the evolution of their pain, de-emphasizes the patho-anatomical content and focuses on factors contributing to the development of pain. It explains this all within a biopsychosocial framework, which means that it aims to optimize patients' beliefs. Furthermore, it intends to reassure the patient about the decision to have surgery, to potentially decrease perioperative distress.

  • Perioperative Biomedical EducationBehavioural

    Perioperative biomedical education will discuss the anatomy, physiology and biomechanics of the lumbar spine with the patient. Additionally, the content of this education includes the expected course of postoperative back and leg pain, as well as ergonomic advice on patient-specific daily activities. This education will be given within a biomedical framework, which means that it aims to explain the patients' complaints and recovery while focusing on anatomy and biomechanics, as opposed to patients' beliefs and cognitions.

Study groups in NCT05047679
Study groupRoleWhat they receive
Perioperative Pain Neuroscience EducationExperimentalPatients in the experimental treatment group will receive Perioperative Pain Neuroscience Education, including a preoperative session 3 days before the surgery, access to an educational web application and a postoperative session 2 days following the surgery. Both education sessions will be face-to-face and will last approximately 60 minutes.
Receives: Behavioral: Perioperative Pain Neuroscience Education
Perioperative Biomedical EducationActive comparatorPatients in the control treatment group will receive Perioperative Biomedical Education, including a preoperative session 3 days before the surgery, access to an educational web application and a postoperative session 2 days following the surgery. Both education sessions will be face-to-face and will last approximately 60 minutes.
Receives: Behavioral: Perioperative Biomedical Education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in health-related quality of life

    Change in health-related quality of life will be be assessed by the Short Form 36-item Health Survey (SF-36). The SF-36 contains 8 subscales: physical, emotional, social and role functioning, bodily pain, mental health, vitality and general health. The psychometric properties are well established in a wide variety of patient populations, and its responsiveness to change following surgical interventions is superior than other generic health status measurement scales commonly used in evaluations of interventions for chronic, disabling pain. Additionally, the 5-level EuroQol 5-dimensions (EQ-5D*), which also has good measurement properties, will be used to calculate the change in health utility values between baseline and 1 year post-surgery.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery*

Secondary outcomes (9)

  1. Change in self-reported leg and low back pain intensity

    Pain intensity for the leg and low back will be assessed by a series of 100mm Visual Analogue Scales (VAS). The VAS pain score is believed to be reliable, valid and sensitive to change. More specifically the patient will be asked to rate their highest and lowest pain severity in the last 24 hours for back or leg pain, and mean pain in the last 24 hours, as well as current pain for the back and leg separately.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery

  2. Change in analgesic use

    Analgesic use will be assessed by a self-reported recall questionnaire, which has been proven to be valid and feasible for a period up to 6 months. Patients will be asked to report the name of the medication, frequency of use, dose and whether it was prescribed or not. Also, patients are asked to indicate whether the medication was taken because of their back or leg pain, and if not, what the reason was for taking this medication.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery

  3. Return to work (6 weeks post-surgery)

    Return to work will be assessed by asking patients whether they already resumed professional activities, and if yes, since when they resumed work and to what extent. Also, patients will be given the opportunity to mention whether they had to change jobs or job content for effective work resumption. Additionally, prescribed sick leave is recorded separately by asking patients to report the dates of the doctor's notes.

    Measured: 6 weeks post-surgery

  4. Return to work (6 months post-surgery)

    Return to work will be assessed by asking patients whether they resumed or maintained professional activities, and if yes, since when they resumed work and to what extent they are currently working. Also, patients will be given the opportunity to mention whether they had to change jobs or job content for effective work resumption or maintenance. Additionally, prescribed sick leave is recorded separately by asking patients to report the dates of the doctor's notes.

    Measured: 6 months post-surgery

  5. Return to work (1 year post-surgery)

    Return to work will be assessed by asking patients whether they resumed or maintained professional activities, and if yes, since when they resumed work and to what extent they are currently working. Also, patients will be given the opportunity to mention whether they had to change jobs or job content for effective work resumption or maintenance. Additionally, prescribed sick leave is recorded separately by asking patients to report the dates of the doctor's notes.

    Measured: 1 year post-surgery

  6. Change in self-reported symptoms of central sensitization

    The Dutch Central Sensitization Inventory (CSI) will be used to assess self-reported symptoms of central sensitization. The CSI consists of 25 statements about symptoms that people with chronic pain might encounter, such as sensitivity to light or concentration difficulties. A reported higher degree of self-symptomology regarding central sensitization indicates the potential presence of hypersensitivity. It shows good validity for assessing symptoms of central sensitization in patients with chronic pain.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery

  7. Change in kinesiophobia

    Kinesiophobia will be assessed with the Tampa Scale for Kinesiophobia (TSK), which is a questionnaire consisting of 17 items, and the total score can range from 17 to 68 with higher scores indicating higher levels of kinesiophobia. It has good clinimetric properties in patients with low back pain.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery

  8. Change in pain catastrophizing

    Pain catastrophizing will be assessed with the Pain Catastrophizing Scale (PCS), which has well-established clinimetric properties. It consists of 13 items describing different thought and feelings that individuals may experience when they are experiencing pain, total scores range from 0 to 52, with higher scores indicating more catastrophizing.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery

  9. Change in pain hypervigilance

    Pain hypervigilance will be assessed using the Pain Vigilance and Awareness Questionnaire (PVAQ), which is designed to measure attention to pain by assessing awareness, consciousness, vigilance and observation of pain. This questionnaire consists of 16 items and total scores can range from 0 to 90, with higher scores indicating more pain vigilance. These items have demonstrated good internal consistency reliability (Cronbach's alpha = 0.86) in patients with chronic low back pain.

    Measured: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start30 Sep 2021
  3. Primary completion16 Oct 2023
  4. Study completion16 Oct 2023

Why it stopped: Recruitment issues that could not be resolved in a timely manner.

Resources

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, Outcomes assessor
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047679
Sponsor's protocol ID
FWOSB108
Other IDs
1S61521N
Acronym
B²EARS
Status last verified
Nov 2023
First submitted
3 Sep 2021
Last updated
28 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Given the confidential nature of the collected data, the raw data will not be made open access following the study. However, excluding all possible personal identifiable data (e.g., date of birth and date of surgery), the pseudonymized data of all outcome measures (i.e., health-related quality of life, pain intensity, analgesic use, return to work, self-reported symptoms of central sensitization, pain catastrophizing, kinesiophobia and pain hypervigilance), as well as general demographic data (e.g., age, height, weight and education level) will be made available via a data repository with restricted access.

Publications

  • Ickmans K, Moens M, Putman K, Buyl R, Goudman L, Huysmans E, Diener I, Logghe T, Louw A, Nijs J. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial. J Physiother. 2016 Jul;62(3):165. doi: 10.1016/j.jphys.2016.05.009. Epub 2016 Jun 11.

    PubMed 27298051

  • 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 23478459

  • 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.

    PubMed 24875964

  • Wilson CA, Roffey DM, Chow D, Alkherayf F, Wai EK. A systematic review of preoperative predictors for postoperative clinical outcomes following lumbar discectomy. Spine J. 2016 Nov;16(11):1413-1422. doi: 10.1016/j.spinee.2016.08.003. Epub 2016 Aug 4.

    PubMed 27497886

  • den Boer JJ, Oostendorp RA, Beems T, Munneke M, Oerlemans M, Evers AW. A systematic review of bio-psychosocial risk factors for an unfavourable outcome after lumbar disc surgery. Eur Spine J. 2006 May;15(5):527-36. doi: 10.1007/s00586-005-0910-x. Epub 2005 May 25.

    PubMed 15915334

  • den Boer JJ, Oostendorp RA, Beems T, Munneke M, Evers AW. Continued disability and pain after lumbar disc surgery: the role of cognitive-behavioral factors. Pain. 2006 Jul;123(1-2):45-52. doi: 10.1016/j.pain.2006.02.008. Epub 2006 Mar 24.

    PubMed 16563624

  • Taylor RS, Taylor RJ. The economic impact of failed back surgery syndrome. Br J Pain. 2012 Nov;6(4):174-81. doi: 10.1177/2049463712470887.

    PubMed 26516490

  • Inoue S, Kamiya M, Nishihara M, Arai YP, Ikemoto T, Ushida T. Prevalence, characteristics, and burden of failed back surgery syndrome: the influence of various residual symptoms on patient satisfaction and quality of life as assessed by a nationwide Internet survey in Japan. J Pain Res. 2017 Apr 6;10:811-823. doi: 10.2147/JPR.S129295. eCollection 2017.

    PubMed 28435318

  • Manca A, Eldabe S, Buchser E, Kumar K, Taylor RS. Relationship between health-related quality of life, pain, and functional disability in neuropathic pain patients with failed back surgery syndrome. Value Health. 2010 Jan-Feb;13(1):95-102. doi: 10.1111/j.1524-4733.2009.00588.x. Epub 2009 Aug 20.

    PubMed 19695004

  • Van Oosterwijck J, Nijs J, Meeus M, Truijen S, Craps J, Van den Keybus N, Paul L. Pain neurophysiology education improves cognitions, pain thresholds, and movement performance in people with chronic whiplash: a pilot study. J Rehabil Res Dev. 2011;48(1):43-58. doi: 10.1682/jrrd.2009.12.0206.

    PubMed 21328162

  • Meeus M, Nijs J, Van Oosterwijck J, Van Alsenoy V, Truijen S. Pain physiology education improves pain beliefs in patients with chronic fatigue syndrome compared with pacing and self-management education: a double-blind randomized controlled trial. Arch Phys Med Rehabil. 2010 Aug;91(8):1153-9. doi: 10.1016/j.apmr.2010.04.020.

    PubMed 20684894

  • Louw A, Diener I, Landers MR, Zimney K, Puentedura EJ. Three-year follow-up of a randomized controlled trial comparing preoperative neuroscience education for patients undergoing surgery for lumbar radiculopathy. J Spine Surg. 2016 Dec;2(4):289-298. doi: 10.21037/jss.2016.12.04.

    PubMed 28097246

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Perioperative Pain Neuroscience Education and Perioperative Biomedical Education in people with Lumbar Radiculopathy, run by Vrije Universiteit Brussel at 4 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 was stopped early (reason given: Recruitment issues that could not be resolved in a timely manner.). Results are not available in the source record.

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?

Change in health-related quality of life (time frame: Change between baseline (1 week before surgery) and 6 weeks post-surgery, baseline and 6 months post-surgery, baseline and 1 year post-surgery*). 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 NCT05047679, which also lists 15 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 28 Nov 2023.

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