Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Predictors of Work Resumption After Back Surgery (WABS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747860
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
RIZIV
Information provided by (Responsible Party):
Johan Vlaeyen, KU Leuven

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This prospective, longitudinal study aims to identify modifiable predictors of return to work after back surgery.

Condition or disease
Low Back Pain

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Generalization of Fear of Movement-related Pain and Avoidance Behavior as Predictors of Work Resumption After Back Surgery. A Prospective Study
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Self-reported (sustainable) work resumption assessed by self-report questionnaires [ Time Frame: 6 weeks 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.

  2. Self-reported (sustainable) work resumption assessed by self-report questionnaires [ Time Frame: 3 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.

  3. Self-reported (sustainable) work resumption assessed by self-report questionnaires [ Time Frame: 6 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.

  4. Self-reported (sustainable) work resumption assessed by self-report questionnaires [ Time Frame: 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 :
  1. Self-reported ratings of how much pain the participants experiences, assessed by one question of the short Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ) [ Time Frame: 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.

  2. Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ [ Time Frame: 3 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.

  3. Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ [ Time Frame: 6 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.

  4. Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ [ Time Frame: 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.

  5. Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI) [ Time Frame: 6 weeks 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.

  6. Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI) [ Time Frame: 3 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.

  7. Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI) [ Time Frame: 6 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.

  8. Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI) [ Time Frame: 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.

  9. Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale [ Time Frame: 6 weeks 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.

  10. Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale [ Time Frame: 3 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.

  11. Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale [ Time Frame: 6 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.

  12. Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with low back pain who will undergo back surgery
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04747860


Contacts
Layout table for location contacts
Contact: Rini Masuy +32 16 37 66 41 rini.masuy@kuleuven.be
Contact: Steefka Zijlstra steefka.zijlstra@kuleuven.be

Locations
Layout table for location information
Belgium
GasthuisZusters Antwerpen (GZA) (campus Sint-Augustinus), department of Neurosurgery Recruiting
Wilrijk, Antwerpen, Belgium, 2610
Contact: Catherine Celis       cathcelis@gmail.com   
Principal Investigator: Kris De Smedt, MD         
Centre Hospitalier de Wallonie picarde (CHwapi), department of Neurosurgery Not yet recruiting
Tournai, Henegouwen, Belgium, 7500
Contact: Sarah Lonneville       sarah.lonneville@chwapi.be   
Principal Investigator: Sarah Lonneville, MD         
Ziekenhuis Oost-Limburg, department of Neurosurgery Recruiting
Genk, Limburg, Belgium, 3600
Contact: Cindy Vangompel       cindy.vangompel@zol.be   
Principal Investigator: Dieter Peuskens, MD         
Mariaziekenhuis Noord-Limburg, departement of Orthopedics Recruiting
Overpelt, Limburg, Belgium, 3900
Contact: Patricia Sutens       secretariaat.orthopedie@noorderhart.be   
Principal Investigator: Vorlat Peter, MD         
AZ Sint-Lucas Gent, departement of Orthopedics Recruiting
Gent, Oost-Vlaanderen, Belgium, 9000
Contact: Charlotte Lezy       charlotte.lezy2@azstlucas.be   
Principal Investigator: Johan Van Lerbeirghe, MD         
University Hospital Leuven, department of Neurosurgery Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Dominike Bruyninckx       dominike.bruyninckx@uzleuven.be   
Principal Investigator: Bart Depreitere, MD, PhD         
Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery Not yet recruiting
Tienen, Vlaams-Brabant, Belgium, 3300
Contact: Patrick Van Schaeybroeck       patrick.vanschaeybroeck@skynet.be   
Principal Investigator: Patrick Van Schaeybroeck, MD         
AZ Groeninge (campus kennedylaan), department of Neurosurgery Recruiting
Kortrijk, West-Vlaanderen, Belgium, 8500
Contact: Isabelle Boscart       ISABELLE.BOSCART@azgroeninge.be   
Principal Investigator: Jeroen Ceuppens, MD         
Imeldaziekenhuis, department of Neurosurgery Recruiting
Bonheiden, Belgium, 2820
Contact: Ellen Van Loon       ellen.van.loon@imelda.be   
Principal Investigator: Patrick Van Schaeybroeck, MD         
Sponsors and Collaborators
KU Leuven
RIZIV
Investigators
Layout table for investigator information
Principal Investigator: Johan WS Vlaeyen, PhD Health Psychology, KU Leuven
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Johan Vlaeyen, Principal Investigator, Professor, KU Leuven
ClinicalTrials.gov Identifier: NCT04747860    
Other Study ID Numbers: S63018
ctu2019088 ( Registry Identifier: FearedBack ZOL )
AZGS2020051 ( Registry Identifier: FearedBack AZ Groeninge )
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johan Vlaeyen, KU Leuven:
Low back pain
Back surgery
Postoperative pain
Predictors of return to work
Fear of movement-related pain
 Avoidance
Fear generalization
Avoidance generalization
Disability
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations