Low Back PainWABSNCT04747860
Predictors of Work Resumption After Back Surgery
An observational study of Low Back Pain, run by KU Leuven at 9 sites in Belgium.
Trial summary
This prospective, longitudinal study aims to identify modifiable predictors of return to work after back surgery. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Low Back Pain
- How many people
- 300 participants
- Where
- 9 sitesBelgium
- Study dates
- 23 Feb 2021to 1 Feb 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with low back pain who will undergo back surgery
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
Steefka Zijlstra contact
9 sites in 1 country
Belgium9 sites, 9 recruiting
- Recruiting
Imeldaziekenhuis, department of Neurosurgery
Bonheiden, 2820
Ellen Van Loon, ellen.van.loon@imelda.be
Patrick Van Schaeybroeck, MD
- Recruiting
Ziekenhuis Oost-Limburg, department of Neurosurgery
Genk, Limburg, 3600
Cindy Vangompel, cindy.vangompel@zol.be
Dieter Peuskens, MD
- Recruiting
AZ Sint-Lucas Gent, departement of Orthopedics
Ghent, Oost-Vlaanderen, 9000
Charlotte Lezy, charlotte.lezy2@azstlucas.be
Johan Van Lerbeirghe, MD
- Recruiting
AZ Groeninge (campus kennedylaan), department of Neurosurgery
Kortrijk, West-Vlaanderen, 8500
Isabelle Boscart, ISABELLE.BOSCART@azgroeninge.be
Jeroen Ceuppens, MD
- Not yet recruiting
University Hospital Leuven, department of Neurosurgery
Leuven, Vlaams-Brabant, 3000
Dominike Bruyninckx, dominike.bruyninckx@uzleuven.be
Bart Depreitere, MD, PhD
- Recruiting
Mariaziekenhuis Noord-Limburg, departement of Orthopedics
Overpelt, Limburg, 3900
Patricia Sutens, secretariaat.orthopedie@noorderhart.be
Vorlat Peter, MD
- Not yet recruiting
Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery
Tienen, Vlaams-Brabant, 3300
Patrick Van Schaeybroeck, patrick.vanschaeybroeck@skynet.be
Patrick Van Schaeybroeck, MD
- Not yet recruiting
Centre Hospitalier de Wallonie picarde (CHwapi), department of Neurosurgery
Tournai, Henegouwen, 7500
Sarah Lonneville, sarah.lonneville@chwapi.be
Sarah Lonneville, MD
- Recruiting
GasthuisZusters Antwerpen (GZA) (campus Sint-Augustinus), department of Neurosurgery
Wilrijk, Antwerpen, 2610
Catherine Celis, cathcelis@gmail.com
Kris De Smedt, MD
About this study
Official title: Generalization of Fear of Movement-related Pain and Avoidance Behavior as Predictors of Work Resumption After Back Surgery. A Prospective Study
This prospective, longitudinal study aims to identify modifiable predictors of return to work after back surgery.
Read the 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.
- Conditions
- Low Back Pain
- Keywords
- 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
- Medical subject headings
- Low Back Pain, Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
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.
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.
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)
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.
Measured: 6 weeks post-surgery
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
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.
Measured: 3 months post-surgery
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
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.
Measured: 6 months post-surgery
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
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.
Measured: 12 months post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
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.
Measured: 6 weeks post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
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.
Measured: 3 months post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
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.
Measured: 6 months post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
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.
Measured: 12 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
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.
Measured: 6 weeks 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
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.
Measured: 3 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
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.
Measured: 6 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
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.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start23 Feb 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- RIZIV
- Responsible party
- Principal investigator, Johan Vlaeyen, KU Leuven
- Investigators
- Johan WS Vlaeyen, PhD, Principal investigator, Health Psychology, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747860
- Sponsor's protocol ID
- S63018
- Other IDs
- ctu2019088, AZGS2020051
- Acronym
- WABS
- Status last verified
- Sep 2021
- First submitted
- 20 Aug 2018
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35193697
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generalization of Fear of Movement-related Pain and Avoidance Behavior as Predictors of Work Resumption After Back Surgery. A Prospective Study
- ClinicalTrials.gov ID
- NCT04747860
- Acronym / sponsor ID
- WABS / S63018
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Back surgery, Postoperative pain, Predictors of return to work, Fear of movement-related pain, Avoidance, Fear generalization, Avoidance generalization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- RIZIV
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with low back pain who will undergo back surgery
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
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
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
Time frame: 3 months post-surgery
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
Time frame: 6 months post-surgery
Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
Time frame: 12 months post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
Time frame: 6 weeks post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
Time frame: 3 months post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
Time frame: 6 months post-surgery
Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
Time frame: 12 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
Time frame: 6 weeks 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
Time frame: 3 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
Time frame: 6 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
Time frame: 12 months post-surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Derived from this study: PubMed 35193697Masuy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steefka Zijlstra contact
Johan WS Vlaeyen, PhD principal investigator
Health Psychology, KU Leuven
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by KU Leuven at 9 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rini Masuy (+32 16 37 66 41, rini.masuy@kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported (sustainable) work resumption assessed by self-report questionnaires (time frame: 6 weeks post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.