Effect of Lumbar Spinal Fusion Predicted by Physiotherapists

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673436
• Other study ID #: 1
• Status: Completed
• Start date: September 30, 2018
• Est. completion date: October 1, 2020

Study information

• Verified date: March 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: October 1, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Low Back Pain

Intervention

Procedure:
• Lumbar spinal fusion
The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae

Locations

Country	Name	City	State
Denmark	Department of Occupational and Physiotherapy, Rigshospitalet Glostrup	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Frederiksberg University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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