Back Pain
Conditions
Brief summary
A single blinded RCT for adult patients with spine pain. One group had a lumbar laminectomy with denervation of the facet joint at the level decompressed. The other group had a lumbar laminectomy without facet joint denervation. Both groups had their back pain and functional limitations measured using a 10 cm visual analogue scale and the Oswestry disability index (ODI). All measures were taken before surgery and at patients' 6, 12 and 24 week follow-up clinic visit.
Interventions
PROCEDUREfacet joint denervation
Bipolar electrocautery
Sponsors
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged 19 or older * a diagnosis of spinal stenosis * having neurogenic claudication * complained of back pain for at least 3 months
Exclusion criteria
* previous surgery on their spine, * fracture, systemic inflammatory disease, * malignancies or an infection affecting their spine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual analog scale for pain (VAS) | change from baseline score at 24 weeks | 10 centimeter scale with a minimum of 0 indicating no pain and a maximum of 10 indicating worst pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Oswestry Disability score (ODI) | change from baseline score at 24 weeks | The ODI is divided into ten sections designed to assess limitations of various activities of daily living. Each section is scored on a 0-5 scale. The range of scores is 0 to a maximum of 60. The total score is multiplied by 2 and expressed as a percentage. A score of 0 to 20 points indicates minimal disability; 20 to 40 points, moderate disability; and 40 to 60 points, severe disability. |
Outcome results
None listed