Predictors of Work Resumption After Back Surgery

Last updated: September 1, 2021
Sponsor: KU Leuven
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04747860
S63018
ctu2019088
AZGS2020051
  • Ages 18-55
  • All Genders

Study Summary

This prospective, longitudinal study aims to identify modifiable predictors of return to work after back surgery.

Eligibility Criteria

Inclusion

Inclusion criteria:

  • Age between 18 and 55 years
  • Proper mastery of the Dutch, English and/or French language
  • Intermittent or constant invalidating lumbosciatica for less than 1 year prior to theplanned surgery
  • Discogenic or stenotic radicular pain in the leg(s) that will be treated surgically byperforming a decompression without it leading to fusion and/or fixation
  • Self-employed or has an employment contract, and is on sick leave for less than 1 yearat the day of the surgery

Exclusion

Exclusion criteria:

  • Treated (ambulant or residential) for substance abuse, suicidal ideation or apsychotic disorder in the year before the consult with the surgeon. Ty
  • At least one back surgery in the last 5 years
  • Presence of a comorbid condition (e.g. a severe neurological deficit, a pulmonaryembolism, permanent paralysis, and another pain problem in the limbs), which mayaffect the pain, the outcome of the surgery, the duration of the rehabilitation,and/or the patient's capacity to return to work during the course of the study

Study Design

Total Participants: 300
Study Start date:
February 23, 2021
Estimated Completion Date:
February 01, 2023

Study Description

Background | Over the past decade, the number of back surgeries in Belgium has substantially increased. However, even after an anatomically successful surgery, 10% to 40% of the patients continue to report pain complaints, causing personal suffering and an enormous economic burden. The specific factors that can predict individual trajectories in postoperative pain, recovery, and work resumption are currently largely unknown.

Aim | The aim of this study is to identify modifiable predictors of work resumption after back surgery.

Methods | In this multisite, prospective, longitudinal study, 300 individuals undergoing back surgery will be followed one-year post-surgery. Prior to surgery, the participants will perform a behavioral computer task to assess fear of movement-related pain and avoidance behavior, and their generalization. In addition, participants will complete questionnaires to assess preoperative fear of movement-related pain, avoidance behavior, optimism, expectancies towards recovery and work resumption, and the duration and severity of the pain before the surgery. Immediately after surgery, as well as six weeks, three months, six months, and twelve months postoperatively, sustainable work resumption, pain severity, disability, and quality of life will be assessed.

Hypothesis | The primary hypothesis is that generalization of fear of movement-related pain and avoidance behavior will negatively affect sustainable work resumption after back surgery. Second, the investigators hypothesize that generalization of fear of movement-related pain and avoidance behavior, negative expectancies towards recovery and work resumption, longer pain duration, and more severe pain before the surgery will negatively affect work resumption, pain severity, disability, and quality of life after back surgery. In contrast, positive expectancies towards recovery and work resumption and optimism are expected positively influence work resumption, pain severity, disability, and quality of life.

Connect with a study center

  • GasthuisZusters Antwerpen (GZA) (campus Sint-Augustinus), department of Neurosurgery

    Wilrijk, Antwerpen 2610
    Belgium

    Active - Recruiting

  • Centre Hospitalier de Wallonie picarde (CHwapi), department of Neurosurgery

    Tournai, Henegouwen 7500
    Belgium

    Site Not Available

  • Ziekenhuis Oost-Limburg, department of Neurosurgery

    Genk, Limburg 3600
    Belgium

    Active - Recruiting

  • Mariaziekenhuis Noord-Limburg, departement of Orthopedics

    Overpelt, Limburg 3900
    Belgium

    Active - Recruiting

  • AZ Sint-Lucas Gent, departement of Orthopedics

    Gent, Oost-Vlaanderen 9000
    Belgium

    Active - Recruiting

  • University Hospital Leuven, department of Neurosurgery

    Leuven, Vlaams-Brabant 3000
    Belgium

    Site Not Available

  • Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery

    Tienen, Vlaams-Brabant 3300
    Belgium

    Site Not Available

  • AZ Groeninge (campus kennedylaan), department of Neurosurgery

    Kortrijk, West-Vlaanderen 8500
    Belgium

    Active - Recruiting

  • Imeldaziekenhuis, department of Neurosurgery

    Bonheiden, 2820
    Belgium

    Active - Recruiting

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