Viewing Study NCT04747860



Ignite Creation Date: 2024-05-06 @ 3:46 PM
Last Modification Date: 2024-10-26 @ 1:56 PM
Study NCT ID: NCT04747860
Status: UNKNOWN
Last Update Posted: 2021-09-02
First Post: 2018-08-20

Brief Title: Predictors of Work Resumption After Back Surgery
Sponsor: KU Leuven
Organization: KU Leuven

Study Overview

Official Title: Generalization of Fear of Movement-related Pain and Avoidance Behavior as Predictors of Work Resumption After Back Surgery A Prospective Study
Status: UNKNOWN
Status Verified Date: 2021-09
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: WABS
Brief Summary: This prospective longitudinal study aims to identify modifiable predictors of return to work after back surgery
Detailed 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
AZGS2020051 REGISTRY FearedBack AZ Groeninge None
ctu2019088 REGISTRY None None