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OpenTrials
Completed

NCT Number: NCT05791422

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

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.

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Key information

Conditions

Low Back Pain Back Pain Bone Diseases Lumbar Spinal Stenosis Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spinal Stenosis

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Assuit university hospitals

Asyut, Asyut Governorate, 71511, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Patients with grade one spondylolisthesis without evident instability can be added.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Changes in VAS score for low back pain following decompression surgery and in the follow up visits .

    Time frame: 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 outcomes

  1. Changes in ODI following decompression surgery and in the follow up visits.

    Time frame: 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

  2. Changes in EQ 5D 5l following decompression surgery and in the follow up visits.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 30, 2023
Registry last updated
Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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