Effect of Lumbar Spinal Fusion Predicted by Physiotherapists

Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Lumbar spinal fusion

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.

• Study Type: Observational
• Enrollment (Actual): 202

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Department of Occupational and Physiotherapy, Rigshospitalet Glostrup

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study population consist of 200 patients with lumbar spinal fusion operated at a hospital in Denmark

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with low back pain; Cohort of 200 low back pain patients, 18 years+, who have been undergoing a lumbar spinal fusion	Procedure: Lumbar spinal fusion; The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	Disability will be measured using the Oswestry Disability Index. ODI is a validated measure of condition-specific disability originally developed for patients with LBP. The ODI consists of ten items regarding pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling. For each item the patient chooses one of six answers, with 0 representing no difficulty in the activity and 5 representing maximal difficulty.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported movement capacity	Patients are asked to mark the position along a horizontal 10-cm line that best corresponded to their movement capacity. The endings of the line have verbal descriptions: 0 (''very poor capacity'') - 100 ("very good capacity")	1 year
Back Pain	A visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. Patients are asked to mark the position along a horizontal 10-cm line that best corresponded to their pain intensity. The endings of the line have verbal descriptions: 0 (''no pain'') - 100 ("the worst pain imaginable")	1 year
Leg Pain	A visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. Patients are asked to mark the position along a horizontal 10-cm line that best corresponded to their pain intensity. The endings of the line have verbal descriptions: 0 (''no pain'') - 100 ("the worst pain imaginable")	1 year
Health outcome and quality of life	Quality of life will be assessed using the EuroQol 5 Dimensions 3 levels (EQ-5D-3L). The EQ-5D is a generic questionnaire developed by an international research group including re-searchers from Denmark. EQ-5D-3L consist of 5 dimensions in health-related quality of life: Mobility, Self-care, usual activities, Pain/discomfort, and anxiety/depression. Each dimension is divided into three levels: no problems, some problems or extreme problems. EQ-5D-3L also include a 20-cm vertical scale, were the respondent are asked to describe his/her own health with endpoints of 'best imaginable health state' set at 100 and 'worst imaginable health state' set at 0. The EQ-5D has been validated in Danish, including the development of preference values and Danish population norms.	1 year
Questionnaire regarding postoperative rehabilitation	We will administer a questionnaire that includes questions regarding the postoperative rehabilitation. It is questions regarding: setting, duration, participation and the degree of relevance to the individual patient. The patient will answer the questionnaire by a yes or no and detailed answers by text.	1 year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Frederiksberg University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2018
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: September 12, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No