Study Results
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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UNKNOWN
300 participants
OBSERVATIONAL
2021-02-23
2023-02-01
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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RIZIV
UNKNOWN
KU Leuven
OTHER
Responsible Party
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Johan Vlaeyen
Principal Investigator, Professor
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
Centre Hospitalier de Wallonie picarde (CHwapi), department of Neurosurgery
Tournai, Henegouwen, Belgium
Ziekenhuis Oost-Limburg, department of Neurosurgery
Genk, Limburg, Belgium
Mariaziekenhuis Noord-Limburg, departement of Orthopedics
Overpelt, Limburg, Belgium
AZ Sint-Lucas Gent, departement of Orthopedics
Ghent, Oost-Vlaanderen, Belgium
University Hospital Leuven, department of Neurosurgery
Leuven, Vlaams-Brabant, Belgium
Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery
Tienen, Vlaams-Brabant, Belgium
AZ Groeninge (campus kennedylaan), department of Neurosurgery
Kortrijk, West-Vlaanderen, Belgium
Imeldaziekenhuis, department of Neurosurgery
Bonheiden, , Belgium
Countries
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Central Contacts
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Facility Contacts
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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.
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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