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

January 21, 2025 updated by: Mahmoud Ahmed Fayek Amin, Assiut University

Improvement of Low Back Pain After Surgical Decompression in Patients with Degenerative Lumbar 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Assiut
      • Assuit, Assiut, Egypt, 71511
        • Assuit University hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 .

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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."
1 year post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year post operative
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
1 year post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2023

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

March 15, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBPSD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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