Improvement of Low Back Pain After Decompression in Patients with Degenerative Spinal Canal Stenosis

Completed

• Conditions: Low Back Pain; Lumbar Spinal Stenosis

• Registration Number: NCT05791422
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-15
• Study Start: 2023-03-20
• Study First Submitted QC: 2023-03-29
• Study First Posted: 2023-03-30
• Primary Completion: 2024-12-20
• Study Completion: 2024-12-20
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in VAS score for low back pain following decompression surgery and in the follow up visits .	1 year post operative	The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Secondary Outcome Measures

Name	Time	Method
Changes in ODI following decompression surgery and in the follow up visits.	1 year post operative	ODI is a 10-item self-assessing questionnaire, each item contains 6 levels of answers that can be scored from 0 to 5
Changes in EQ 5D 5l following decompression surgery and in the follow up visits.	1 year post operative	EQ-5D-5L is a descriptive system that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression

Trial Locations

Locations (1)

Assuit university hospitals; 🇪🇬 Assuit, Assiut, Egypt