Clinical trial NCT03673436: Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Official title: Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Frederiksberg University Hospital
First posted: 2018-09-17
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consist of 200 patients with lumbar spinal fusion operated at a hospital in Denmark

Brief summary: The main purpose of this study is to investigate if improvements in patient self-reported pain, symptoms, function and quality of life 12 months after Lumbar spinal fusion among patients that have good projected prognosis differ from those among patients with a poor projected prognosis.

The secondary purpose is to explore the underlying factors of the physiotherapists projected prognosis to identify objective and possible modifiable candidate prognostic factors for recovery.

Detailed description: Background:

Over recent decades, an increasing number of patients with Chronic Low Back Pain (CLBP) undergo surgical lumbar spinal fusion (LSF). For many of the patients LSF is their last resort in the hope of a better life with less pain, disability and use of medication. Unfortunately, several reports show, that the pain level remains the same after LSF for many patients, and that consumption of medication remains unchanged in almost 50 % of the patients.

Knowing that characteristics such as maladaptive coping strategies, fear avoidance beliefs and pain catastrophizing seem to be predictive of worse outcome in pain, function and quality of life after surgery. It is important to assess how these individual factors in the postsurgical rehabilitation can be addressed.

The single physiotherapists have an essential role in mobilizing the LSF patient post-operatively. In clinical practice it is not enough for the physiotherapists to use their biomechanical understanding of LSF material and heeling processes, it is also essential to use a so-called "silent knowledge" of experience and personal interaction with the patient.

It remains unknown if this "silent knowledge" is a reliable predictor of the outcome of LSF surgery. If the physiotherapist can predict the outcome, it is important to explore which factors the physiotherapist rely their prognosis upon in order to identify objective and possible modifiable candidate prognostic factors for recovery.

The aim of this study is to assess if physiotherapists attending inpatients at public back surgery hospitals can predict the future course (post hospitalisation) of recovery of patients undergoing LSF. The study will also break down the physiotherapists' "silent knowledge" in an attempt to identify objective (and hopefully modifiable) candidate prognostic markers of recovery.

Eligibility criteria: Inclusion Criteria:

* Received primary LSF surgery for treatment of CLBP
* Degenerative lumbar disease with or without lumbar spondylolisthesis grades 1 to 2
* Fusion of a maximum of 3 adjacent vertebrae
* Above 18 years of age
* Competence in the Danish language
* Has an email address

Exclusion Criteria:

* Prior LSF surgery
* Cognitive impairments that preclude reliable answers to patient reported outcome questionnaire

Primary outcomes:
measure: Oswestry Disability Index
timeFrame: 1 year
Secondary outcomes:
measure: Patient reported movement capacity
timeFrame: 1 year
measure: Back Pain
timeFrame: 1 year
measure: Leg Pain
timeFrame: 1 year
measure: Health outcome and quality of life
timeFrame: 1 year
measure: Questionnaire regarding postoperative rehabilitation
timeFrame: 1 year
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Occupational and Physiotherapy, Rigshospitalet Glostrup
Study officials:
References: