Predictors of Work Resumption After Back Surgery

NCT ID: NCT04747860

Last Updated: 2021-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-23

Study Completion Date

2023-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 the planned surgery
* Discogenic or stenotic radicular pain in the leg(s) that will be treated surgically by performing 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 year at the day of the surgery

Exclusion Criteria

* Treated (ambulant or residential) for substance abuse, suicidal ideation or a psychotic 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 pulmonary embolism, permanent paralysis, and another pain problem in the limbs), which may affect 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RIZIV

UNKNOWN

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Johan Vlaeyen

Principal Investigator, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Johan WS Vlaeyen, PhD

Role: PRINCIPAL_INVESTIGATOR

Health Psychology, KU Leuven

Locations

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

Wilrijk, Antwerpen, Belgium

Site Status RECRUITING

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

Tournai, Henegouwen, Belgium

Site Status NOT_YET_RECRUITING

Ziekenhuis Oost-Limburg, department of Neurosurgery

Genk, Limburg, Belgium

Site Status RECRUITING

Mariaziekenhuis Noord-Limburg, departement of Orthopedics

Overpelt, Limburg, Belgium

Site Status RECRUITING

AZ Sint-Lucas Gent, departement of Orthopedics

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

University Hospital Leuven, department of Neurosurgery

Leuven, Vlaams-Brabant, Belgium

Site Status NOT_YET_RECRUITING

Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery

Tienen, Vlaams-Brabant, Belgium

Site Status NOT_YET_RECRUITING

AZ Groeninge (campus kennedylaan), department of Neurosurgery

Kortrijk, West-Vlaanderen, Belgium

Site Status RECRUITING

Imeldaziekenhuis, department of Neurosurgery

Bonheiden, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Rini Masuy

Role: CONTACT

+32 16 37 66 41

Steefka Zijlstra

Role: CONTACT

Facility Contacts

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Catherine Celis

Role: primary

Sarah Lonneville

Role: primary

Cindy Vangompel

Role: primary

Patricia Sutens

Role: primary

Charlotte Lezy

Role: primary

Dominike Bruyninckx

Role: primary

Patrick Van Schaeybroeck

Role: primary

Isabelle Boscart

Role: primary

Ellen Van Loon

Role: primary

References

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Masuy R, Bamelis L, Bogaerts K, Depreitere B, De Smedt K, Ceuppens J, Lenaert B, Lonneville S, Peuskens D, Van Lerbeirghe J, Van Schaeybroeck P, Vorlat P, Zijlstra S, Meulders A, Vlaeyen JWS. Generalization of fear of movement-related pain and avoidance behavior as predictors of work resumption after back surgery: a study protocol for a prospective study (WABS). BMC Psychol. 2022 Feb 22;10(1):39. doi: 10.1186/s40359-022-00736-5.

Reference Type DERIVED
PMID: 35193697 (View on PubMed)

Other Identifiers

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ctu2019088

Identifier Type: REGISTRY

Identifier Source: secondary_id

AZGS2020051

Identifier Type: REGISTRY

Identifier Source: secondary_id

S63018

Identifier Type: -

Identifier Source: org_study_id

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