Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 202
- Locations
- 1
- Primary Endpoint
- Oswestry Disability Index
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Health outcome and quality of life(1 year)
- Questionnaire regarding postoperative rehabilitation(1 year)
- Patient reported movement capacity(1 year)
- Back Pain(1 year)
- Leg Pain(1 year)
Investigators
Heidi Tegner
Clinical physiotherapy supervisor, PT, MScH
Rigshospitalet, Denmark