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Predictors of Work Resumption After Back Surgery (WABS)

C

Catholic University (KU) of Leuven

Status

Unknown

Conditions

Low Back Pain

Study type

Observational

Funder types

Other

Identifiers

NCT04747860
ctu2019088 (Registry Identifier)
S63018
AZGS2020051 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

300 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

9

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Central trial contact

Steefka Zijlstra; Rini Masuy

Data sourced from clinicaltrials.gov

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