Clinical trial NCT04747860: Predictors of Work Resumption After Back Surgery
Official title: Generalization of Fear of Movement-related Pain and Avoidance Behavior as Predictors of Work Resumption After Back Surgery. A Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
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
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: RIZIV
First posted: 2021-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low back pain who will undergo back surgery

Brief summary: 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.

Eligibility 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

Primary outcomes:
measure: Self-reported (sustainable) work resumption assessed by self-report questionnaires
timeFrame: 6 weeks post-surgery
measure: Self-reported (sustainable) work resumption assessed by self-report questionnaires
timeFrame: 3 months post-surgery
measure: Self-reported (sustainable) work resumption assessed by self-report questionnaires
timeFrame: 6 months post-surgery
measure: Self-reported (sustainable) work resumption assessed by self-report questionnaires
timeFrame: 12 months post-surgery
Secondary outcomes:
measure: Self-reported ratings of how much pain the participants experiences, assessed by one question of the short Örebro Musculoskeletal Pain Screening Questionnaire (ÖMPSQ)
timeFrame: 6 weeks post-surgery
measure: Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
timeFrame: 3 months post-surgery
measure: Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
timeFrame: 6 months post-surgery
measure: Self-reported ratings of how much pain the participants experiences, assessed by one question of the short ÖMPSQ
timeFrame: 12 months post-surgery
measure: Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
timeFrame: 6 weeks post-surgery
measure: Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
timeFrame: 3 months post-surgery
measure: Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
timeFrame: 6 months post-surgery
measure: Self-reported ratings of the extent that pain interferes with functioning, assessed by Pain Disability Index (PDI)
timeFrame: 12 months post-surgery
measure: Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale
timeFrame: 6 weeks post-surgery
measure: Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale
timeFrame: 3 months post-surgery
measure: Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale
timeFrame: 6 months post-surgery
measure: Self-reported ratings of how satisfied the participants is with his/her life overall, assessed by one item of the Riverside Life Satisfaction Scale
timeFrame: 12 months post-surgery
Other outcomes:
Locations:
city: Wilrijk
country: Belgium
facility: GasthuisZusters Antwerpen (GZA) (campus Sint-Augustinus), department of Neurosurgery
state: Antwerpen
city: Tournai
country: Belgium
facility: Centre Hospitalier de Wallonie picarde (CHwapi), department of Neurosurgery
state: Henegouwen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg, department of Neurosurgery
state: Limburg
city: Overpelt
country: Belgium
facility: Mariaziekenhuis Noord-Limburg, departement of Orthopedics
state: Limburg
city: Gent
country: Belgium
facility: AZ Sint-Lucas Gent, departement of Orthopedics
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: University Hospital Leuven, department of Neurosurgery
state: Vlaams-Brabant
city: Tienen
country: Belgium
facility: Regionaal Ziekenhuis Heilig Hart Tienen, department of Neurosurgery
state: Vlaams-Brabant
city: Kortrijk
country: Belgium
facility: AZ Groeninge (campus kennedylaan), department of Neurosurgery
state: West-Vlaanderen
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis, department of Neurosurgery
Study officials:
affiliation: Health Psychology, KU Leuven
name: Johan WS Vlaeyen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.