Status:
COMPLETED
The Effect of Graded Activity and Pain Education (GAPE) for Patients Early After Lumbar Spinal Fusion
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Frederiksberg University Hospital
Defactum, Central Denmark Region
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background An increasing number of patients with chronic low back pain (CLBP) undergo lumbar spinal fusion (LSF). Unfortunately, a substantial part of the patients still has persistent pain, functiona...
Detailed Description
Introduction: Over half a Billion people worldwide report low back pain (LBP), and it is the leading cause of disability at all levels of income and age groups. For the majority of people with LBP th...
Eligibility Criteria
Inclusion
- Patients from the Capital Region of Denmark undergoing LSF at Centre for Rheumatology and Spine Diseases, Rigshospitalet, Glostrup from 23st of September 2019 to 30st marts 2021 and fulfilling the following criteria:
- Low back pain \> six months
- \>18 years
- Undergoing an instrumented spinal posterior fusion of 1-2 spinal segments for degeneration of the lumbar spine, with or without an intervertebral cage placed from the anterior approach, posterior approach or from a lateral access.
- Degenerative conditions include disc herniation, spinal stenosis, spondylosis with or with-out myelopathy and spondylolisthesis.
- Read and understand Danish
- Lives no more than 1 ½ hour of transportation from Rigshospitalet, Glostrup
Exclusion
- Has previously been through an LSF
- One or more of following conditions (infection, neoplasm, metastasis, metabolic bone dis-ease, fractures, post-traumatic vertebral compression/deformity or other known autoimmune arthropathies)
- Are cognitively or otherwise unable to give informed consent and adhere to the study program
- Other special conditions where a patient is judged not able to participate in the intervention by the surgeon or researcher (HT) (weakness caused by very high age, extreme poorly functional level, other serious comorbidities)
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT04103970
Start Date
October 1 2019
End Date
March 1 2022
Last Update
November 15 2024
Active Locations (1)
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1
Department of Occupational and Physiotherapy, Rigshospitalet Glostrup
Glostrup Municipality, Denmark, 2600