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NCT Number: NCT03673436

Effect of Lumbar Spinal Fusion Predicted by Physiotherapists

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Occupational and Physiotherapy, Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumbar spinal fusion

Procedure

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

Primary outcomes

  1. Oswestry Disability Index

    Time frame: 1 year

    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.

Secondary outcomes

  1. Patient reported movement capacity

    Time frame: 1 year

    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")

  2. Back Pain

    Time frame: 1 year

    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")

  3. Leg Pain

    Time frame: 1 year

    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")

  4. Health outcome and quality of life

    Time frame: 1 year

    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.

  5. Questionnaire regarding postoperative rehabilitation

    Time frame: 1 year

    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.

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Frederiksberg University Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 17, 2018
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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