Clinical trial NCT05791422: Improvement of Low Back Pain After Decompression in Patients with Degenerative Spinal Canal Stenosis
Official title: Improvement of Low Back Pain After Surgical Decompression in Patients with Degenerative Lumbar Spinal Canal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Lumbar Spinal Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with degenerative lumbar spine disease admitted to Assiut University Hospitals, Department of Orthopaedic and Trauma Surgery to whom lumbar decompression surgery is indicated .

Brief summary: Degenerative lumbar spine disease is a leading cause of disability in the world; it encompasses conditions such as spondylolisthesis, disc degeneration, and lumbar spinal stenosis. Those conditions present with a variety of clinical symptoms, including lower extremity pain, weakness, and low back pain (LBP) of varying levels of severity and in severe cases urine and stool incontinence may result.

Detailed description: Degenerative lumbar spine disease is a common indication for lumbar decompression surgery, especially in elderly patients. Moreover, Clinical studies prove that decompression is superior to conservative treatment with more favorable outcomes .

Surgical options for decompressing the lumbar spine vary from minimally invasive disc decompression to open laminectomy and foraminotomy.

The surgery aims to improve the quality of life in appropriately selected patients , in the form of improvement of walking distance, lower limbs pain, and other symptoms of spinal compression.

Few papers assessed LBP improvement after lumbar decompression surgery . The common practice that patients with degenerative canal stenosis and low back pain should undergo fusion surgery is not evidence based.

In this study the investigators aim to assess the improvement of clinical symptoms, especially low back pain and lower limbs pain in patients with degenerative lumbar spine disease after undergoing lumbar decompression surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients with degenerative lumbar spine disease admitted to Assiut University Hospitals, Department of Orthopaedic and Trauma Surgery between March 2023 and March 2024, to whom lumbar decompression surgery is indicated regardless of age or neurological symptoms.
2. Patients with grade one spondylolisthesis without evident instability can be added.

Exclusion Criteria:

1. Patients who are not available for follow up
2. Patients who refuse to participate in the study
3. Patients with evidence of instability
4. Previously operated patients on the same or adjacent segment.

Primary outcomes:
measure: Changes in VAS score for low back pain following decompression surgery and in the follow up visits .
timeFrame: 1 year post operative
Secondary outcomes:
measure: Changes in ODI following decompression surgery and in the follow up visits.
timeFrame: 1 year post operative
measure: Changes in EQ 5D 5l following decompression surgery and in the follow up visits.
timeFrame: 1 year post operative
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Assuit university hospitals
state: Assiut
Study officials:
References:
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