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

NCT05047679 | Terminated

• 2 other identifiers: FWOSB1081S61521N
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Lumbar Radiculopathy

Keywords

Biomedical Education; Pain Neuroscience Education; Lumbar surgery; Education; Chronic pain; Kinesiophobia; Catastrophization; Perioperative Education

Outcome Measures

Primary Outcomes (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.

  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)

• Change in self-reported leg and low back pain intensity

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

• Change in analgesic use

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

• Return to work (6 weeks post-surgery)

  6 weeks post-surgery

• Return to work (6 months post-surgery)

  6 months post-surgery

• Return to work (1 year post-surgery)

  1 year post-surgery

Other Outcomes (2)

• Demographic data

  Baseline (1 week before surgery)

• Health literacy

  Baseline (1 week before surgery)

Study Arms (2)

Perioperative Pain Neuroscience Education

EXPERIMENTAL

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.

Behavioral: Perioperative Pain Neuroscience Education

Perioperative Biomedical Education

ACTIVE COMPARATOR

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.

Behavioral: Perioperative Biomedical Education

Interventions

Perioperative Pain Neuroscience Education BEHAVIORAL

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.

Also known as: Pain Education

Perioperative Pain Neuroscience Education

Perioperative Biomedical Education BEHAVIORAL

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.

Perioperative Biomedical Education

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• Research Foundation Flanders: collaborator

Study Sites (4)

AZ Rivierenland

Bornem, Antwerpen, 2880, Belgium

Location

AZ Sint-Dimpna

Geel, Antwerpen, 2440, Belgium

Location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

ZNA Middelheim

Antwerp, 2020, Belgium

Location

Related Publications (15)

• 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.

  PMID: 27298051 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

• 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

• 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.

  PMID: 27497886 BACKGROUND

• 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.

  PMID: 15915334 BACKGROUND

• 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.

  PMID: 16563624 BACKGROUND

• 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.

  PMID: 26516490 BACKGROUND

• 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.

  PMID: 28435318 BACKGROUND

• 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.

  PMID: 19695004 BACKGROUND

• 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.

  PMID: 21328162 BACKGROUND

• 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.

  PMID: 20684894 BACKGROUND

• 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.

  PMID: 28097246 BACKGROUND

• 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

MeSH Terms

Conditions

Radiculopathy; Chronic Pain; Kinesiophobia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Jo Nijs, Prof. Dr.

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the participant and the person responsible for the monitoring of the baseline and follow-up assessments will be masked.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 17, 2021
• Study Start: September 30, 2021
• Primary Completion: October 16, 2023
• Study Completion: October 16, 2023
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Following the study, the data will be stored at a data repository with restricted access for 10 years.
• Access Criteria: Only researchers who intend to use and analyze the pseudonymized data for the purpose of scientific research can request access to the data. Additionally, researchers who intend to use the data are required to provide a statistical plan including the predetermined research question and detailing the intended analyses. Also, details regarding the storage of the shared data should be provided to ensure that the researchers took the appropriate measures to establish a secure storage location for the shared data. A request for data access can be send to the central contact person and a data sharing agreement will be signed by both parties.

Locations

BE (4)