Trials / Completed
CompletedNCT03673436
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
Effect of Lumbar Spinal Fusion Predicted by Physiotherapists: A Prospective Cohort Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 202 (actual)
- Sponsor
- Rigshospitalet, Denmark · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Lumbar spinal fusion | The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae |
Timeline
- Start date
- 2018-09-30
- Primary completion
- 2020-10-01
- Completion
- 2020-10-01
- First posted
- 2018-09-17
- Last updated
- 2021-03-10
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03673436. Inclusion in this directory is not an endorsement.