Predictors of Work Resumption After Back Surgery

• Conditions: Low Back Pain

• Registration Number: NCT04747860
• Lead Sponsor: KU Leuven

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 Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2021-02-05
• Study First Posted: 2021-02-10
• Study Start: 2021-02-23
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported (sustainable) work resumption assessed by self-report questionnaires	12 months post-surgery	The investigators make a distinction between being fit for work, work resumption, and sustainable work resumption. Being fit for work will be operationalized by not receiving disability benefits. Work resumption will be operationalized by being at work without receiving disability benefits, and time to relapse. Time to relapse is defined as the time for participants to be in sick leave again after being fit for work. Sustainable work resumption will be operationalized by being at work for at least three consecutive months without receiving disability benefits. In addition, the duration of work resumption will be measured.

Secondary Outcome Measures

Name	Time	Method
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ	12 months post-surgery	Pain severity will be operationalized as the intensity of the pain, and will be assessed by one questions of the short ÖMPSQ (Linton et al., 2011). Participants are requested to answer this item (i.e., How would you rate the pain that you have had during the past week?) on a numerical rating scale with labels from 0 = no pain to 10 = pain as bad as it could be. The score on this item will be used as a measure of pain severity before and immediately after the surgery (as baseline measures) and six weeks, three months, six months and twelve months post-surgery.
Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale	12 months post-surgery	Quality of life will be operationalized as satisfaction with life. It will be measured by the one item of the Riverside Life Satisfaction Scale (RLSS) with the highest factor loading (Margolis et al., 2019). Participants are requested to answer this item (i.e., I am satisfied with my life overall.) on a 7-point Likert scale ranging from strongly disagree to strongly agree.
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)	6 weeks post-surgery	Pain severity will be operationalized as the intensity of the pain, and will be assessed by one questions of the short ÖMPSQ (Linton et al., 2011). Participants are requested to answer this item (i.e., How would you rate the pain that you have had during the past week?) on a numerical rating scale with labels from 0 = no pain to 10 = pain as bad as it could be. The score on this item will be used as a measure of pain severity before and immediately after the surgery (as baseline measures) and six weeks, three months, six months and twelve months post-surgery.
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)	12 months post-surgery	Disability will be operationalized as the degree to which pain interferes with functioning, and will be assessed by the Pain Disability Index (PDI) questionnaire (Pollard, 1984). The PDI is a self-report questionnaire that measures the degree to which pain interferes with functioning in seven areas: i.e., family/home responsibilities, recreation, social activity, occupation, sexual behavior, self-care, and life-support activity (Tait et al., 1990). Ratings for each item range from 0 = no disability to 5 = total disability. A total score will be calculated as a reliable and valid (Tait et al., 1990) measure of degree of disability before and immediately after the surgery (as baseline measures) and six weeks, three months, six months and twelve months post-surgery.

Trial Locations

Locations (9)

Centre Hospitalier de Wallonie picarde (CHwapi), department of Neurosurgery; 🇧🇪 Tournai, Henegouwen, Belgium

Ziekenhuis Oost-Limburg, department of Neurosurgery; 🇧🇪 Genk, Limburg, Belgium

University Hospital Leuven, department of Neurosurgery; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery; 🇧🇪 Tienen, Vlaams-Brabant, Belgium

Mariaziekenhuis Noord-Limburg, departement of Orthopedics; 🇧🇪 Overpelt, Limburg, Belgium

AZ Groeninge (campus kennedylaan), department of Neurosurgery; 🇧🇪 Kortrijk, West-Vlaanderen, Belgium

GasthuisZusters Antwerpen (GZA) (campus Sint-Augustinus), department of Neurosurgery; 🇧🇪 Wilrijk, Antwerpen, Belgium

AZ Sint-Lucas Gent, departement of Orthopedics; 🇧🇪 Gent, Oost-Vlaanderen, Belgium

Imeldaziekenhuis, department of Neurosurgery; 🇧🇪 Bonheiden, Belgium