Effect of Lumbar Spinal Fusion Predicted by Physiotherapists
1 other identifier
observational
202
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2018
CompletedFirst Posted
Study publicly available on registry
September 17, 2018
CompletedStudy Start
First participant enrolled
September 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedMarch 10, 2021
March 1, 2021
2 years
September 12, 2018
March 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Patient reported movement capacity
1 year
Back Pain
1 year
Leg Pain
1 year
Health outcome and quality of life
1 year
Questionnaire regarding postoperative rehabilitation
1 year
Study Arms (1)
Patients with low back pain
Cohort of 200 low back pain patients, 18 years+, who have been undergoing a lumbar spinal fusion
Interventions
The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae
Eligibility Criteria
The study population consist of 200 patients with lumbar spinal fusion operated at a hospital in Denmark
You may qualify if:
- 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
You may not qualify if:
- Prior LSF surgery
- Cognitive impairments that preclude reliable answers to patient reported outcome questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rigshospitalet, Denmarklead
- Frederiksberg University Hospitalcollaborator
Study Sites (1)
Department of Occupational and Physiotherapy, Rigshospitalet Glostrup
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical physiotherapy supervisor, PT, MScH
Study Record Dates
First Submitted
September 12, 2018
First Posted
September 17, 2018
Study Start
September 30, 2018
Primary Completion
October 1, 2020
Study Completion
October 1, 2020
Last Updated
March 10, 2021
Record last verified: 2021-03