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

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05791422
Collaborator
(none)
30
11.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Improvement of Low Back Pain After Surgical Decompression in Patients With Degenerative Lumbar Spinal Canal Stenosis
    Anticipated Study Start Date :
    Mar 20, 2023
    Anticipated Primary Completion Date :
    Mar 1, 2024
    Anticipated Study Completion Date :
    Mar 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mahmoud Ahmed Fayek Amin, Principle Investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05791422
    Other Study ID Numbers:
    • LBPSD
    First Posted:
    Mar 30, 2023
    Last Update Posted:
    Mar 30, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 30, 2023