Effect of Lumbar Spinal Fusion Predicted by Physiotherapists

NCT ID: NCT03673436

Last Updated: 2021-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-30

Study Completion Date

2020-10-01

Brief Summary

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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

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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.

Conditions

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Low Back Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with low back pain

Cohort of 200 low back pain patients, 18 years+, who have been undergoing a lumbar spinal fusion

Lumbar spinal fusion

Intervention Type PROCEDURE

The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae

Interventions

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Lumbar spinal fusion

The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Frederiksberg University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Heidi Tegner

Clinical physiotherapy supervisor, PT, MScH

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Occupational and Physiotherapy, Rigshospitalet Glostrup

Glostrup Municipality, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id

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