The Effectiveness of Pain Neuroscience Education in At-risk Patients Following Surgery for Lumbar Radiculopathy
NCT ID: NCT05047679
Last Updated: 2023-11-28
Study Results
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Basic Information
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TERMINATED
NA
6 participants
INTERVENTIONAL
2021-09-30
2023-10-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Perioperative Pain Neuroscience Education
Patients 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.
Perioperative Pain Neuroscience 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 Education
Patients 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.
Perioperative Biomedical Education
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.
Interventions
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Perioperative Pain Neuroscience 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 Education
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Research Foundation Flanders
OTHER
Vrije Universiteit Brussel
OTHER
Responsible Party
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Jo Nijs
Professor
Principal Investigators
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Jo Nijs, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Vrije Universiteit Brussel
Locations
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AZ Rivierenland
Bornem, Antwerpen, Belgium
AZ Sint-Dimpna
Geel, Antwerpen, Belgium
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, Belgium
ZNA Middelheim
Antwerp, , Belgium
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1S61521N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FWOSB108
Identifier Type: -
Identifier Source: org_study_id