NCT04747860

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2018

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

September 2, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

August 20, 2018

Last Update Submit

September 1, 2021

Conditions

Low Back Pain

Keywords

Low back painBack surgeryPostoperative painPredictors of return to workFear of movement-related painAvoidanceFear generalizationAvoidance generalizationDisabilityQuality of life

Outcome Measures

Primary Outcomes (4)

  • Self-reported (sustainable) work resumption assessed by self-report questionnaires

    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.

    6 weeks post-surgery

  • Self-reported (sustainable) work resumption assessed by self-report questionnaires

    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.

    3 months post-surgery

  • Self-reported (sustainable) work resumption assessed by self-report questionnaires

    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.

    6 months post-surgery

  • Self-reported (sustainable) work resumption assessed by self-report questionnaires

    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.

    12 months post-surgery

Secondary Outcomes (12)

  • 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

  • Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ

    3 months post-surgery

  • Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ

    6 months post-surgery

  • Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ

    12 months post-surgery

  • Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)

    6 weeks post-surgery

  • +7 more secondary outcomes

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients with low back pain who will undergo back surgery

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

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

Wilrijk, Antwerpen, 2610, Belgium

RECRUITING

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

Tournai, Henegouwen, 7500, Belgium

NOT YET RECRUITING

Ziekenhuis Oost-Limburg, department of Neurosurgery

Genk, Limburg, 3600, Belgium

RECRUITING

Mariaziekenhuis Noord-Limburg, departement of Orthopedics

Overpelt, Limburg, 3900, Belgium

RECRUITING

AZ Sint-Lucas Gent, departement of Orthopedics

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

University Hospital Leuven, department of Neurosurgery

Leuven, Vlaams-Brabant, 3000, Belgium

NOT YET RECRUITING

Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery

Tienen, Vlaams-Brabant, 3300, Belgium

NOT YET RECRUITING

AZ Groeninge (campus kennedylaan), department of Neurosurgery

Kortrijk, West-Vlaanderen, 8500, Belgium

RECRUITING

Imeldaziekenhuis, department of Neurosurgery

Bonheiden, 2820, Belgium

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35193697DERIVED

MeSH Terms

Conditions

Low Back PainPain, Postoperative

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Johan WS Vlaeyen, PhD

    Health Psychology, KU Leuven

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rini Masuy

CONTACT

+32 16 37 66 41rini.masuy@kuleuven.be

Steefka Zijlstra

CONTACT

steefka.zijlstra@kuleuven.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor

Study Record Dates

First Submitted

August 20, 2018

First Posted

February 10, 2021

Study Start

February 23, 2021

Primary Completion

February 1, 2023

Study Completion

February 1, 2023

Last Updated

September 2, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(9)